Disease & Vaccine Information

COVID-19 Overview



covid-19

Below are brief introductions to COVID-19 disease and the COVID-19 vaccine with links to more information. Scroll down for a list of QUICK FACTS that provide a summary overview of key facts for the disease and the vaccine.

SARS-Coronavirus-2 (SARS-CoV-2) and COVID-19

Most coronaviruses, including those causing the common cold, are not associated with significant mortality. The novel SARS-Coronavirus-2 (SARS-CoV-2) identified in 2019 causes a collection of symptoms that can cause severe illness, which has become known as COVID-19. The SARS-CoV-2 virus is contagious  and infected persons can be asymptomatic  or exhibit symptoms ranging from mild to severe. Symptoms include fever; chills; cough; shortness of breath/difficulty breathing; fatigue; muscle, joint or body aches; rash; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting and diarrhea. 

Complications of SARS-CoV-2 include pneumonia, acute respiratory failure, Acute, Respiratory Distress Syndrome (ARDS), acute kidney, liver, and heart injury, septic shock, disseminated intravascular coagulation (DIC), rhabdomyolysis (muscle breakdown), chronic fatigue syndrome, blood clots and death. Many complications may be caused by a condition known as a cytokine storm. 

Research on natural immunity from SARS-CoV-2 infection varies and suggests that durable immunity to the virus lasts for at least 20 months  and may be life-long.  An August 2021 retrospective study of Israel’s second largest HMO found that natural immunity “confers longer lasting and stronger protection against infection, symptomatic disease, and hospitalization caused by the Delta variant.”  Click to learn more about SARS-CoV-2 virus…

COVID-19 Vaccine

New ways to make vaccines including new technologies and production platforms, such as mRNA vaccines, have become favored over the older traditional ways to make vaccines in the COVID-19 vaccine race.    Messenger RNA (mRNA) vaccines are gene based vaccines that involve injecting lipid nanoparticles containing mRNA (genetic code) that enable the vaccine to get past the cell wall, into the intracellular space, then causes the cell’s ribosome to make viral proteins (antigen that stimulate the immune system.)  In essence, an mRNA vaccine tricks the body into producing the viral proteins to trigger an immune response.  

There are two mRNA COVID-19 vaccines licensed and recommended in the U.S. by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC).    There are four additional COVID-19 Vaccines are available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines for use in infants and children aged 6 months through 4 years and for children five through 11 years of age  and one mRNA COVID-19 vaccine for use in infants aged 6 months through 11 years.  There is one protein subunit vaccine authorized for use in individuals 12 years of age and older. 

Under EUA authority, the FDA Commissioner may permit unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.  EUA status, however, also shields vaccine manufacturers and providers from liability under the Public Readiness and Emergency Preparedness Act (PREP Act). 

The EUA status granted to these vaccines does not mean that the FDA has evaluated all safety and efficacy data. For example, the CDC reported in July 2021, after general use in the population under EUA status, that COVID-19 vaccines did not prevent infection the fully vaccinated or transmission of the virus by the fully vaccinated.  Additionally, multiple studies have found that vaccine effectiveness wanes quickly and vaccinated persons may be more at risk of infection.             

NVIC encourages consumers to make informed vaccination decisions and to read the FDA fact sheet and other information and resources provided on our website.  Click to learn more about COVID-19 vaccines…

SARS-CoV-2 & COVID-19 Quick Facts

  • A few coronavirus strains can cause very severe respiratory disease with significant mortality, such as Severe Acute Respiratory Syndrome (SARS) that emerged in China in 2002-2003  and Middle Eastern Respiratory Syndrome (MERS) that was first reported in Saudi Arabia in 2012.  SARS-CoV-2, which was identified in China in late 2019  and declared a global pandemic by the World Health Organization (WHO) in March 2020,    has a much lower mortality rate than SARS or MERS. 

  • In 2020, the U.S. Centers for Disease Control and Prevention (CDC) reported that about 94 percent of COVID-19 related-deaths occurred in persons over age 65 and individuals with underlying poor health conditions.  According to the CDC, those considered to be at highest risk for severe COVID-19 disease are the immunocompromised; pregnant women; individuals with chronic heart, lung or kidney disease; the obese; type 2 diabetics; and individuals with cancer, Down’s syndrome, sickle cell disease and thalassemia. There are other chronic health conditions that might increase risks for severe COVID-19 disease, including asthma, high blood pressure, dementia and neurologic conditions, liver disease, cystic fibrosis, and type 1 diabetes.  Click to read more COVID-19 Quick Facts…

Coronavirus Vaccine Quick Facts

  • On Mar. 10, 2020, the U.S. Secretary of the Department of Health and Human Services (DHHS) declared the COVID-19 pandemic a public health emergency and invoked the 2005 Public Readiness and Emergency Preparedness (PREP) Act. The public health emergency ended in the U.S. on May 11, 2023. However, COVID-19 vaccines remain a public health emergency “countermeasures” and continue to fall under the PREP Act, which shields manufacturers and vaccine providers from liability. The Countermeasures Injury Compensation Program (CICP) awards compensation to those injured by countermeasure vaccines.       

  • There are two COVID-19 vaccines for use in the U.S. Comirnaty mRNA COVID-19 vaccine,  developed and manufactured by Pfizer-BioNTech, and Spikevax mRNA COVID-19 vaccine,  developed and manufactured by Moderna. Both vaccines are monovalent mRNA COVID-19 vaccines containing the SARS-CoV-2 Omicron variant XBB.1.5. and are approved for use in individuals age 12 years and older.

  • Additional COVID-19 Vaccines available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines produced by Pfizer-BioNTech for use in infants and children aged 6 months through 4 years and for children five through 11 years of age  and one mRNA COVID-19 vaccine produced by Moderna for use in infants aged 6 months through 11 years.  There is one protein subunit vaccine, Novavax, authorized for use in individuals 12 years of age and older.   Click to read more COVID-19 Quick Facts…

IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

What is SARS-Coronavirus-2 and COVID-19 (SARS-CoV-2)?

 covid-19

Coronaviruses come from a large family of viruses that are known to cause infections like the common cold. Named for their crown-like spiked surfaces, these viruses are further classified into four additional sub-groups known as alpha, beta, delta, and gamma.

First identified in the mid-1960’s, there are seven known coronaviruses that can cause illness in humans. The four common coronaviruses circulating among humans are: 

  • 229E (alpha coronavirus)
  • NL63 (alpha coronavirus)
  • OC43 (beta coronavirus)
  • HKU1 (beta coronavirus)

Symptoms of common coronaviruses include cough, headache, sore throat, runny nose, fever, and general malaise. In persons with heart and lung disease, infants, older adults, and person with immune disorders, additional illnesses may include lower respiratory infections such as bronchitis and pneumonia. 

There are three human coronaviruses known to cause severe illness in humans.

The first coronavirus recognized as causing severe illness in humans was identified in 2003 and became known as Severe Acute Respiratory Syndrome (SARS). Health officials believe that the virus originated from an animal source, possibly a bat, and infected other animals prior to human transmission. The origin of this virus was traced to the Guangdong province of Southern China. Initial symptoms of SARS included headache, malaise, fever, muscle aches, shivering and diarrhea. Shortness of breath, cough, and diarrhea commonly occurred in the first or second week of illness and in serious cases, progressed rapidly to respiratory distress requiring intensive care.  The outbreak was considered contained by July of 2003, and no cases of the illness have been reported since 2004. SARS was believed to have infected 8,096 individuals and resulted in 774 deaths. 

The second, Middle Eastern Respiratory Syndrome (MERS), was identified by health officials in Saudi Arabia in September 2012. The exact origin of the virus remains unknown; however, it is believed to have originated in bats and spread to camels prior to human transmission. Classic symptoms of MERS include cough, fever, and shortness of breath. Respiratory distress requiring intensive care and mechanical ventilation occurs in severe cases. While the fatality rate of MERS is estimated at 35 percent, health officials believe that the true fatality rate is lower since milder cases are likely not diagnosed. The virus is not easily transmitted, and most infections have occurred in health care settings among personnel providing care to infected individuals. While MERS has been reported in 27 countries, 80 percent of cases have been reported in Saudi Arabia.  Only two cases of MERS have been reported in the U.S. and both involved health care providers residing and working in Saudi Arabia. 

The third and most recent is the novel SARS-Coronavirus-2 (SARS-CoV-2), which causes a collection of symptoms including severe illness that has become known as COVID-19. Initial reports began on January 8, 2020, when the CDC issued a health advisory alert regarding a cluster of pneumonia cases with links to a wholesale animal and fish market in Wuhan City, in the Hubei province of China. The initial health alert reported illness in 59 individuals with symptom onset dates beginning December 12, 2019 that included shortness of breath and fever. No deaths were reported and according to Chinese health officials, there were no reports of human-to-human transmission. 

Chinese health officials identified the virus as a novel coronavirus on December 31, 2019, and by the end of January 2020, 217 deaths among 9,776 confirmed cases had been reported. On January 30, 2020, the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of International Concern” with health officials reporting that the origin of the virus was likely an unsanitary food market in Wuhan City, China. WHO officials suggested that infected individuals were exposed after consuming infected bats and snakes from the city’s market. 

The origins of SARS-CoV-2, however, has been disputed by many researchers who believe that the virus was most likely leaked from the Wuhan Institute of Virology where scientists were conducting studies on bat coronaviruses.     

COVID-19 Symptoms and Complications

Symptoms of COVID-19, the illness caused by SARS-CoV-2, include: 

  • Cough
  • Congestion
  • Runny nose
  • Shortness of breath
  • Difficulty breathing
  • Fever
  • Chills
  • Fatigue
  • Muscle aches
  • Body aches
  • Sore throat
  • Headache
  • New loss of taste or smell
  • Diarrhea
  • Nausea
  • Vomiting

Complications of the virus include pneumonia, acute respiratory failure, Acute, Respiratory Distress Syndrome (ARDS), acute kidney, liver, and heart injury, septic shock, disseminated intravascular coagulation (DIC), rhabdomyolysis (muscle breakdown), chronic fatigue syndrome, and blood clots. 

Many complications may be caused by a condition known as a cytokine storm. This occurs when an infection triggers the immune system to flood the bloodstream with inflammatory proteins referred to as cytokines, which can damage organs and kill tissue.  Health officials also believe that the virus may trigger a multisystem inflammatory syndrome in children and adolescents known as Multisystem Inflammatory Syndrome in Children (MIS-C). The CDC reports that they do not know what causes this condition but that many children who develop it have a personal health history of exposure to the SARS-CoV-2 virus or have been in contact with an infected individual.  Early in the pandemic, the CDC reported the incident rate of MIS-C to be one in 3,000 to 4,000 children and adolescents infected with SARS-CoV-2. This rate has decreased steadily throughout the pandemic and as of March 2023, MIS-C is considered rare. 

SARS-CoV-2 Variants

Multiple variants of the SARS-CoV-2 virus continue to emerge. Like all viruses, SARS-CoV-2 continually evolve due to genetic mutations during the genome’s replication, which results in a variant. 

The Centers for Disease Control and Prevention (CDC) classify SARS-CoV-2 variants into four distinct categories: Variant Being Monitored; Variant of Interest; Variant of Concern; and Variant of High Consequence. The variant’s transmissibility, the severity of illness, and the effectiveness of current medical treatments factor into the classification of each variant.

As of August 27, 2023, the Omicron variant is the predominant SARS-CoV-2 variant in the U.S. and remains a Variant of Concern.   

Public health experts admit that they are uncertain as to how effective the current authorized treatments and vaccines will be against novel SARS-CoV-2 variants.   

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Is SARS-CoV-2 Contagious?

covid-19

Yes, SARS-CoV-2, which causes COVID-19, is contagious and is transmitted through aerosolized particles and respiratory droplets. These particles and droplets can be inhaled or can enter the mouth, nose, or eyes. 

The U.S. Centers for Disease Control (CDC) has also stated that SARS-CoV-2 transmission can occur when a person touches a contaminated object and then touches their mouth, nose, or eyes.  The risk of transmission from surfaces is considered to be low, and estimated to occur at a rate of one case per 10,000. 

There is also evidence that the virus can be spread through the fecal-oral route, which supports the recommendation for frequent handwashing. Infected feces can contaminate food, surfaces, and hands, and has the potential to cause illness. 

A study published November 19, 2020 in The Lancet Microbe found that the SARS-CoV-2 virus was most contagious in the first five days after the onset of symptoms. This study also reported that there was no difference in the viral loads among asymptomatic or symptomatic SARS-CoV-2-positive individuals, and research indicated that people without symptoms clear the virus more quickly and are therefore less contagious.  Research studies have also found that viral loads among vaccinated and unvaccinated SARS-CoV-2 positive people to be similar.   

A study conducted in the UK found that the SARS-CoV-2 virus lost 90 percent of its virulence within 20 minutes of being exhaled. After only 10 minutes, the virus lost 50 percent of its ability to infect. Humidity of the environment was also determined to play a role in the ability of the virus to infect. When the environment had a humidity level of less than 50 percent, the virus lost its ability to infect within 10 seconds.   

Natural Immunity after SARS-CoV-2 infection

In January 2021, researchers reported that more than 95 percent of people who recovered from SARS-CoV-2 infection had durable immunity to the virus for at least eight months.  Another study conducted by researchers at the Washington University School of Medicine in St. Louis found that persons who recover from COVID-19 illness, including those with asymptomatic and mild cases, continued to have lasting immunity upon recovery. Study researchers also speculated that immunity following COVID-19 infection would likely endure long-term. 

A study conducted by the Cleveland Clinic Health System in June 2021 involving 52,238 employees found that "Not one of the 1,359 previously infected subjects who remained unvaccinated had a [Covid-19] infection over the duration of the study and vaccination did not reduce the risk. Study authors concluded that persons previously infected with SARS-CoV-2 were unlikely to benefit from COVID-19 vaccination.  Another study specific to health care workers in an urban Massachusetts setting between December of 2020 and September of 2021, when the Delta variant was most prominent, also reported no cases of re-infection with SARS-CoV-2 among those previously infected. 

An August 25, 2021 retrospective study of Israel’s second largest HMO, yet to undergo peer review, compared 673,676 vaccinated individuals who had not been previously infected by SARS-CoV-2, 62,883 unvaccinated individuals and 42,099 previously infected individuals with a single vaccine dose. The study found that natural immunity “confers longer lasting and stronger protection against infection, symptomatic disease, and hospitalization caused by the Delta variant.” 

According to a CDC report published in January 2022 on cases and hospitalizations by COVID-19 vaccination status conducted in New York and California between May 2021 and November 2021, unvaccinated individuals with a history of natural SARS-CoV-2 infection had infection rates of between 14.7 and 29 times lower than unvaccinated individuals without prior infection. In contrast, COVID-19-vaccinated individuals with a past history of SARS-CoV-2 infection were noted to have infection rates that were only between 4.5 and 6.2 times lower. Additionally, hospitalization rates among persons with natural immunity were reported to be between 2 and 6 times lower than those who were vaccinated and had no prior infection. 

Over one hundred studies have reported natural immunity to be equal or better than vaccine acquired immunity.   

According to the CDC, as of early October 2021, there have been approximately 146.6 million COVID-19 infections in the U.S.  A survey of blood donor samples completed in December 2021 and updated in February 2022 found that nearly 95 percent of the U.S. population over age 16 have antibodies to COVID-19, either through infection or vaccination.  In April 2022, health officials estimated that approximately 75 percent of U.S. infants and children from birth to 11 years of age had previously been infected. 

The CDC has acknowledged that they have no evidence that any person with natural immunity due to past infection has been able to transmit the virus to another individual. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is the history of SARS-CoV-2 and COVID-19 in America and other countries?

disease history

On January 8, 2020, the U.S. Centers for Disease and Prevention (CDC) issued a health advisory alert regarding a cluster of pneumonia cases with links to a wholesale animal and fish market in Wuhan City, in the Hubei province of China. The initial health alert reported illness in 59 individuals with symptoms that included shortness of breath and fever. No deaths were reported and according to Chinese health officials, there were no reports of human-to-human transmission. 

Initial reports out of China that the virus was unlikely to spread between humans turned out to be inaccurate as more and more cases were confirmed by Chinese and international health authorities. Early news reports, such as one where a patient was suspected of having infected as many as 14 medical staff in one hospital, showed that the infection was spread more easily than initially thought. 

When the virus was first identified, the CDC stated that little was known about how the novel coronavirus, SARS-CoV-2, spread. Initially, beliefs about virus infectiousness were primarily based on what was known about similar coronaviruses – that most transmission occurs from person-to-person between close contacts (about six feet). 

 

Public Health Emergency Declared

Chinese health officials identified the virus as a novel coronavirus on December 31, 2019, and by the end of January 2020, 217 deaths among 9,776 cases had been confirmed. On January 30, 2020, the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of International Concern” with health officials reporting an unsanitary food market in Wuhan City, China as the likely source. WHO officials suggested that infected individuals were exposed through consumption of infected bats and snakes from the city’s market. 

One day later, the U.S. DHHS Secretary Alex M. Azar declared the novel coronavirus a U.S. public health emergency.  U.S. citizens who had been in China’s Hubei Province in the previous 14 days would be subject to a 14-day mandatory quarantine prior to entering the U.S. In addition, the U.S. suspended entry for most travelers who were not U.S. citizens and had recently been in China. 

The COVID-19 U.S. public health emergency remained in effect until May 11, 2023.  

 

Quarantine and Isolation

On February 1, 2020, the Secretary of Defense (DOD) Mark Esper approved a request from the U.S. Department of Health and Human Services (DHHS) for housing support at military bases for 1,000 people, including American citizens who arrived from other countries and could be subject to mandatory quarantine. 

The cruise line industry was one of the first to be adversely affected by government quarantine measures. Thousands of passengers and crew members were not permitted to disembark if anyone on the boat tested positive for SARS-CoV-2.     

On February 6, 2020, the New York Times reported that Chinese government authorities responding to the country’s SARS-CoV-2 epidemic ordered round-the-clock house-to-house police searches to take the temperatures of all Wuhan residents and detain anyone who was sick, or suspected of being sick, using force, if necessary, and then “warehousing them in enormous quarantine centers.” A senior Chinese official announced that both the city where the epidemic began and the whole country faced “wartime conditions” and that “There must be no deserters, or they will be nailed to the pillar of historical shame forever.”  

Videos emerged showing people suspected of being infected forcefully being dragged from their homes by officials wearing masks and white protective suits, as the men and women shouted out in protest and unsuccessfully struggled to break free. Another video showed officials wearing masks, dressed in black and carrying large metal sticks chasing a man suspected of being infected through the largely deserted streets of the city as he ran trying to escape being confined in one of the mass quarantine camps. 

Officials from the Wuhan City Central Hospital also announced that Li Wenliang, the 34-year old ophthalmologist who had been silenced for warning people about the virus in late December 2019, had died from the infection. CNN reported that Dr. Wenliang had been questioned by local authorities in December 2019 after he alerted colleagues and was “later summoned by Wuhan police to sign a reprimand letter in which he was accused of ‘spreading rumors online’ and ‘severely disrupting social order.’”   Chinese officials eventually exonerated Dr. Wenliang and apologized to his family in mid-March 2020.  

On February 11, 2020, the Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, declared that China’s SARS-CoV-2 outbreak posed a “very grave threat for the rest of the world.” He called for creation of a roadmap to accelerate development of drugs and vaccines “around which research and donors will align.”  By February 11, 2020, there had been 44,138 confirmed cases globally. All but a few hundred cases had occurred in mainland China with a total of 1,107 reported deaths. 

 

SARS-CoV-2 Origins Questioned

By mid-February 2020, new questions surfaced about whether the novel coronavirus could be traced back to scientific research conducted in Wuhan labs, a subject that had been widely discussed since January after the outbreak in China emerged.  According to a February 16, 2020 report in the Daily Mail, South China University of Technology scientists wrote a paper questioning whether research on bats and respiratory diseases at the Wuhan Institute of Virology and the Wuhan Centers for Disease Control (WCDC) had created a new chimeric coronavirus capable of infecting humans. The WCDC is located just 300 yards from the fish and wildlife food market thought to be the origin of the coronavirus and is adjacent to the Union Hospital where the first group of doctors were infected. 

On February 15, 2020, a paper was published in The Lancet by Chinese scientists, “Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China.” In this paper, the authors stated that “In December, 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei, China, with clinical presentations greatly resembling viral pneumonia” and they described 41 cases hospitalized by January 2, 2020, of which 66 percent (27 people) had been exposed to the food market and 15 percent (6 people) died.  

As questions about the origin of the virus began circulating, WHO quickly endorsed the theory that it had spontaneously jumped from animals, most likely bats, to humans in the Wuhan market selling seafood and wildlife animals, additionally, the WHO stated that online speculation to the contrary was “misinformation.” In early February 2020, it was reported that WHO had teamed up with Google to battle online “misinformation” about the SARS-CoV-2 epidemic,  and additional meetings included many big tech companies. 

In January 2021, Dr. John Dye, Chief of Viral Immunology for the U.S. Army Medical Research Institute of Infectious Diseases, was interviewed and asked what was known about the origins of SARS-CoV-2 and if the Wuhan lab in China had been ruled out. His response was “No, at this point, nothing has been ruled out. We do not know. It is undetermined whether it was from a laboratory or from an environmental exposure, at this point in time, and we probably never will know.” 

By mid-February 2021, controversy was fueled as revelations by a lead infectious disease expert traveling to Wuhan as a member of an international delegation from the WHO stated that only summary data on early cases were provided to the delegation. Dr. Dwyer added that it was standard practice in an outbreak investigation for raw data to be shared and had yet to be provided by China. 

In an interview on CNN in late March 2021, former CDC Director Robert Redford, MD stated that it was his opinion that the SARS-CoV-2 virus originated in a laboratory in Wuhan China, and transmission had already begun by September or October of 2019. 

Additional investigative reports have provided evidence to support the lab origin theory and have suggested that the U.S. and China were involved in research involving genetic manipulation of bat coronavirus in an attempt to create vaccines and therapeutics. From information uncovered, evidence has found that these projects were funded by U.S. taxpayers and paid out by National Institutes of Health (NIH), including the National Institute of Allergy and Infectious Diseases (NIAID), and the U.S. Agency for International Development (USAID). Reports have also noted that those who have fought hard to debunk the COVID-19 lab origin theory have ties to the vaccine research and funding partnerships with the Wuhan Institute of Virology (WIV).   

In early May 2021, multiple federal legislators requested that the lab origin theory be fully investigated and have requested information on the U.S funding of research completed at the WIV. 

In September 2021, The Intercept announced that it had received over 900 pages of documents outlining the work of EcoHealth Alliance, an organization based in the U.S. that used money from federal agencies to fund bat coronavirus research at the Wuhan Institute of Virology. The documents were made available to the public for review as part of ongoing Freedom of Information Act (FOIA) legislation. 

The released data revealed that experiments on bat coronaviruses took place at the biosafety Level 3 lab at the Wuhan University Center for Animal Experiment and not the WIV. Grant funding, which totaled $3.1 million, also included nearly $600,000 that was used by the WIV to identify and alter bat coronaviruses that had the capability to infect humans. 

NIAID Director Dr. Anthony Fauci has continually denied that his agency funded bat coronavirus research at the WIV.  However, in mid-October 2021, the NIH changed their story and confirmed that they had funded studies in Wuhan that made bat coronavirus more virulent. 

In September 2022, the Lancet published a paper which suggested that SARS-CoV-2 may have originated in a laboratory from experiments on similar coronaviruses.  This paper contradicted their conclusions from 2020, which stated that individuals who did not believe that the virus evolved from a bat were conspiracy theorists and spreading misinformation. 

 

Risk Factors and Severity

In February 2020, information coming out of China suggested that some people were at high risk of complications from COVID-19 infections, but most people had mild symptoms and recovered without treatment.  WHO stated that: 

“Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirusMost people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.”

Evidence published in the medical literature by early March 2020 characterizing the type of COVID-19 disease symptoms and risk factors for severe disease among the population in China revealed that common major symptoms (22-88 percent) included fever, cough, myalgia or fatigue, expectoration and difficulty breathing. Minor symptoms (less than 12 percent) included headache or dizziness, diarrhea, nausea and vomiting, with those aged 60 years or older at higher risk.  Another study published by Chinese scientists found that underlying cardiovascular disease, secondary infections, older age and elevated inflammatory indicators in the blood suggested that COVID-19 mortality might be due to “virus-activated ‘cytokine storm syndrome’ or fulminant myocarditis.” 

 

Pandemic Declaration

By the end of February 2020, WHO had not yet declared COVID-19 to be a pandemic,  but there had been daily reports in the media warning that COVID-19 was taking a foothold in the U.S.  and many concerned Americans had begun to prepare to protect themselves by buying masks, hand sanitizer and stocking up on food and household supplies. On March 1, 2020, former U.S. Surgeon General Dr. Jerome Adams sent out a message on Twitter: 

“Seriously people – STOP BUYING MASKS. They are NOT effective in preventing general public from catching coronavirus but if healthcare providers can’t get them to care for sick patients, it puts them and our communities at risk! The best way to protect yourself and your community is with everyday preventive actions, like staying home when you are sick and washing hands with soap and water, to help slow the spread of respiratory illness. Get your flu shot – fewer flu patients = more resources for COVID-19.”

Former CDC Director Dr. Robert Redfield reported to the House Foreign Affairs Committee that, There is no role for these masks in the community. These masks need to be prioritized for health care professionals that as part of their job are taking care of individuals. 

WHO declared COVID-19 a global pandemic on March 11, 2020, and urged countries to take strong action to stop its spread.    Globally, governments quickly closed borders, restricted or halted travel between and within countries and ordered healthy people to eliminate physical contact with each other by staying in their homes.  The halt to travel and closure of schools, businesses, stores and shopping centers, restaurants, theaters, sports arenas, gyms, beaches, parks and recreation areas, churches, and other places, where children are educated and people conduct business, shop and engage in recreation, sent stock markets into a sudden nosedive   and crippled the world’s economy. 

Two days after WHO declared a COVID-19 pandemic, the New York Times published a widely-quoted article on March 13, 2020, titled “The worst-case estimate for U.S. coronavirus deaths” that raised even more concern about the potential lethality of COVID-19.  The article stated that the CDC had been conferring with epidemiologists at universities around the world and were modeling pandemic COVID-19 scenarios based on what was known about the transmissibility and severity of the new mutated SARS-CoV-2 virus to come up with “worst case” estimates if no actions were taken to slow transmission.  

An epidemic modeler at Johns Hopkins, Lauren Gardner, was quoted as saying, There is a lot of room for improvement if we act appropriately,” and urged people to “change their behavior” to alter the course of the pandemic. University of Nebraska infectious disease specialist, Dr. James Lawler, was quoted as estimating there would be 96 million Americans infected and 450,000 deaths. 

 

CDC Faulty Tests – U.S. Lags in Testing Ability

Testing for the virus, however, was not widely available in many countries. In the U.S., the initial test developed by the CDC was faulty. In most cases, the results came back as inconclusive due to an incorrectly formulated test ingredient. The faulty tests caused significant testing delays. Facilities testing for the virus were forced to send samples directly to the CDC, which resulted in diagnosis delays. Additionally, the CDC severely restricted testing criteria so that few people qualified – including many who presented with COVID-19 symptoms.   

In late February 2020, Science Magazine reported the CDC had only performed 459 tests for the SARS-CoV-2 virus in patients suspected to be infected due to faulty COVID-19 tests.  Additionally, the CDC, which had declined to follow testing guidelines compiled by the World Health Organization, chose to create a more complicated test that could identify additional viruses. This test, however did not work as anticipated. 

At a congressional hearing on March 12, 2020, Director of the National Institute for Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci admitted that the U.S. was unable to meet the required capacity for SARS-CoV-2 testing of everyone in the U.S. who needed it. The system is not really geared to what we need right now, he  said. That is a failing. Let’s admit it. 

On March 22, 2020, the FDA approved a 45-minute lab test to confirm SARS-CoV-2 infections,  however, the testing delays had significantly impaired the U.S. response to the virus. 

Former President Donald Trump declared the novel coronavirus outbreak a national emergency on March 13, 2020. The declaration permitted the president to access up to $50 Billion dollars which would be directed to assist states, localities, and territories impacted by the virus.  On March 15, 2020, Dr. Fauci said on NBC’s Meet the Press:  

“I think Americans should be prepared that they are going to have to hunker down significantly more than we as a country are doing…I think we should really be overly aggressive and get criticized for overreacting.

Dr. Fauci also reported that he had not received any pushback from government officials to his suggestions and stated thatin fairness, they listen and they generally go with what we say.” 

 

Testing Controversy

Results from the reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) test are used to identify individuals infected with the SARS-CoV-2 virus and reported as a simple “yes” or “no” answer to the question of whether someone is infected. 

However, the validity of COVID-19 testing has continually been questioned by some health experts. There are reports that the PCR testing for SARS-CoV-2, the virus associated with COVID-19 illness, is too sensitive and adjustments are needed to distinguish people who have insignificant amounts of harmless viral material in their system versus people who are clinically infected with live virus. The most significant concern is that the number of detection cycles for the test is so high that it reports a positive result for people who have infectious live virus as well as a positive result for people who have only a few genetic fragments left over from a past infection and no longer pose a risk to others.   

A New York Times review published on August 29, 2020 reported on three sets of testing data that included cycle thresholds (CT) values compiled by officials in Massachusetts, New York, and Nevada. The review found that “up to 90 percent of people testing positive barely carried any virus” and experts stated that tests using high CT values may be detecting not only live virus, but also genetic fragments; “leftovers from an infection that pose no particular risk” for contagiousness. The review reported that most tests used a CT value of 40, and noted the CDC’s acknowledgment that samples with a CT value above 33 cycles were unlikely to detect live virus. 

According to the U.S. Food and Drug Administration (FDA), cycle threshold ranges used to determine who is positive are set by commercial manufacturers and laboratories. 

A positive RT-qPCR test does not confirm whether a person is currently ill or will become ill in the future, whether they are infectious or will become infectious, whether they are recovered or recovering from COVID-19, or whether the RT-qPCR test identified a viral fragment from another coronavirus infection in the past. The RT-qPCR test is only capable of reporting that a person has come into contact with coronavirus RNA. 

Carl Heneghan, the director of the Centre for Evidence Based Medicine at the University of Oxford and editor of BMJ Evidence-Based Medicine has expressed concerns regarding the use of PCR testing to confirm a case of COVID-19 and noted: 

“In any other disease we would have a clearly defined specification that would usually involve signs, symptoms, and a test result… We are moving into a biotech world where the norms of clinical reasoning are going out of the window. A PCR test does not equal COVID-19; it should not, but in some definitions it does.”

A systematic review published in September of 2020 in Infectious Diseases and Therapy stated that lower CT values may be associated with severe COVID-19 outcomes and help in predicting the course of the illness. 

Another review published in December 2020 in Clinical Infectious Diseases focused on COVID-19 viral cultures from PCR samples and assessed their infectious potential. A key finding from this review noted that the data suggests that complete live viruses are necessary for transmission of COVID-19, and not fragments that may be identified by PCR tests utilizing a high CT value. The review also estimated that the recovery of live virus from specimens with a CT value greater than 35 was only 8.3 percent, with five studies in the review reporting no growth in specimens with a CT value ranging from 24 to 35. The review also found that infectious potential declined after day 8, including cases with ongoing high viral loads. 

The CDC reports that a person who has recovered from COVID-19 may have low levels of virus in their bodies for up to three months after diagnosis and may test positive, even though they are not spreading COVID-19. 

Addressing the controversial CT value aspect of COVID-19 PCR tests, on January 13, 2021, WHO issued a medical product alert and stated that persons who interpret results for specimens tested using PCR methodology should be aware that "careful interpretation of weak positive results is needed." 

A specimen may be considered weak if a high number of cycles are performed prior to virus detection. This may also mean that the person who provided the specimen might not be infectious.    WHO is advising that a positive PCR test that is not consistent with the clinical presentation of COVID-19 should be confirmed through retesting of a new specimen. 

In May 2021, the CDC issued new guidance to laboratories and recommended reducing the RT-PCR CT value to 28 when testing persons previously vaccinated with the COVID-19 vaccine. This guidance was issued in response to reporting of breakthrough cases of COVID-19 in fully vaccinated individuals. 

On May 19, 2021, the FDA announced that the use of antibody testing to evaluate immunity to SARS-CoV-2 from past infection or vaccination was not recommended.  

According to the FDA, the available authorized SARS-CoV-2 antibody tests are not validated to evaluate protection or immunity to the virus.  

The reliability of COVID-19 testing has also been called into question. Throughout the pandemic, many COVID-19 tests have been recalled for being faulty.         

 

Differing Lockdown Approaches

Quarantine measures varied by state; however, most states implemented lockdown measures that significantly restricted Americans. Businesses deemed non-essential were forced to close, causing financial hardships and skyrocketing unemployment claims.      By the end of March 2020, schools in all 50 states had shut down. 

End-of-life care policies for infected individuals became a topic of discussion as hospitals tried to weigh the ethics of resuscitating critically-ill patients against the risk of exposing health care staff to the SARS-CoV-2, especially since most hospitals were ill-equipped to provide their staff with adequate personal protective equipment (PPE).   

By April 10, 2020, there had been more than 18,000 COVID-19 related deaths reported in the U.S.  According to the CDC, most cases were mild or asymptomatic, including in children,  unless an individual had an underlying chronic health issue such as asthma, obesity, diabetes, autoimmunity, immune suppression, high blood pressure, chronic obstructive pulmonary disease (COPD) or heart disease. 

Large mortality variations among different countries and similar wide variations in mortality among populations living in different states in the U.S. were noted.  At least one study published in early April 2020 found that air pollution subjecting individuals to long-term exposure to fine matter particulates greatly increased the risk for death from COVID-19, and noted that,

“The majority of the pre-existing conditions that increase the risk of death for COVID-19 are the same diseases that are affected by long-term exposure to air pollution.” 

Published data from the CDC confirmed that mortality in the U.S. was much higher among senior citizens over age 65, rising to 10 to 27 percent for those over age 85.  The CDC also stated that the risk of hospitalization and death increased with age. Persons over the age of 85  and those with underlying health conditions were noted to be at highest risk of severe illness and death. 

It was also reported that federal health officials were counting all deaths of persons with SARS-CoV-2 as ‘COVID-19’ deaths, regardless of whether they had underlying health issues that may have contributed. 

 

Many Elderly Die – Department of Justice Reviews State’s with High Counts

In the U.S., the pandemic hit New York City hard. By April 1, 2020, there were 76,049 cases and 1,941 COVID-19-related deaths.  Temporary hospitals were constructed, and the 1,000 bed U.S. Navy Ship Comfort docked to assist in the pandemic’s response. 

COVID-19 deaths in New York City continued to surge. At the same time, questions about the accuracy of the statistics surfaced. In mid-April, New York City added nearly 3,800 deaths to their COVID-19 death statistics, though these deaths were not confirmed. Health officials justified the addition of these unverified deaths, reporting that over 3,000 excess deaths had occurred in the previous month than what would have been typically expected.   

To free up hospital beds, New York health officials ordered nursing homes to accept COVID-19 positive patients. This decision was criticized by many long-term care advocates who expressed concerns that this would place many frail residents at high-risk of illness. Federal health officials had previously banned nearly all nursing home visits, leaving many residents isolated from loved ones. 

By July 2020, reports indicated that more than 6,300 SARS-CoV-2 positive patients had been discharged into nursing homes to recover, resulting in New York nursing home deaths from COVID-19 being highest in the U.S. Former New York Governor Andrew Cuomo denied any link between his administration’s order to return infected patients to nursing homes and the elevated death rates, and instead placed blame on staff members who continued to work while infected. 

In late August 2020, the U.S. Department of Justice announced that it was reviewing nursing home death rates in New York as well as Pennsylvania, New Jersey, and Michigan, to determine whether laws were broken when these states governors used their emergency powers authority to order nursing homes to accept SARS-CoV-2 positive patients.    By mid-February 2021, the media reported on the initiation of an investigation by the FBI and federal prosecutors on Former Governor Cuomo’s nursing home admission policies of March 2020.   

In late July 2021, the U.S. Department of Justice announced that it would not be opening a Civil Rights investigation into COVID-19 nursing home deaths in New York, Michigan, New Jersey, and Pennsylvania. 

 

Reopening After Lockdowns in U.S.

Most states that implemented lockdown orders in March began reopening by early May 2020. Reopening plans varied by state, but most continued to restrict crowd size and imposed additional restrictions  including face mask mandates.  A small number of states, however, chose not to issue lockdown orders. These included Nebraska, Iowa, Arkansas, North and South Dakota. In South Dakota, Governor Kristi Noem refused to implement restrictive measures and stated: 

“Ultimately it is the people themselves that are primarily responsible for their safety,” Noem said. “They are the ones who are entrusted expansive freedoms. They are free to exercise their rights to work, worship, and to play or to stay at home and to conduct social distancing.”

Noem was widely criticized, but stood by her decision, stating that it was her duty to uphold the Constitution. 

According to a report published by the American Legislative Exchange Council (ALEC) on October 20, 2020, South Dakota was ranked 40th in death rates, with 182.3 deaths per 1 million population. In contrast, New Jersey, which issued strict lockdown orders that included penalties, fines, and even jailtime for violations, was ranked first in death rates, at 1,791.6 per 1 million population. 

A working paper published in April 2022 by the National Bureau of Economic Research concluded that lockdowns had essentially no impact on decreasing COVID-19 deaths, but led to significant educational and economic damage. On a state by state basis, Utah, Nebraska, and Vermont were rated highest for their response to COVID-19, while the District of Columbia, New York, and New Jersey were given the lowest rating. 

In the summer of 2021, the state of Florida experienced a surge in COVID-19 cases, hospitalization, and deaths, and was among the most impacted states in the nation. Government officials, however, chose not to implement any restrictive policies such as mask mandates or business closures. Instead, the state focused on making vaccines accessible to individuals who wanted them, and opened monoclonal antibody treatment centers throughout the state. Florida governor Ron DeSantis reported that the spike was seasonal and would wane. Additionally, DeSantis stated that this strategy would work to defeat the pandemic. By the end of October 2021, Florida had one of the lowest rates of COVID-19 cases and deaths. 

In contrast, New York State recorded the highest one-day case count of COVID-19 in mid-December 2021,  despite having one of the highest vaccination rates in the country. 

 

Lockdowns and Reopening Globally

Globally, evidence suggests that lockdowns have not been as effective as hoped and countries that implemented strict restrictions did not fare any better than those who did not. Sweden, a country with a population of 10 million people chose not to lockdown its country because of COVID-19 despite heavy criticism. Although Sweden requested its citizens to stay home if sick and practice social distancing when possible, the government did not close businesses, primary schools, restaurants, shops, gyms and recreational facilities, which prevented the country from suffering the kind of economic meltdown being experienced by most other countries.  

Without lockdowns, Sweden still reported better mortality rate outcomes than Italy, the U.S and the U.K. and its rank in global COVID-19 death rates continues to decline. As of September 22, 2023, Sweden was ranked 44th among nations in population-adjusted deaths from COVID-19. 

In late March 2021, Reuters reported that infectious disease experts stated Sweden’s overall stance on fighting the pandemic had merits worth studying.  The article noted that the more moderate pandemic measures in use by Sweden had spared the country severe economic impacts in comparison to many European countries, and placed its overall excess mortality at 18 out of 26 countries, with Poland, Spain and Belgium ranking at the top. However, excess death rates should be used with caution and are impacted by overall health of the population, as Sweden’s population is healthier than the EU’s average. 

COVID-19 Travel Restrictions

Throughout the pandemic, the CDC issued travel advisories to many countries based on SARS-CoV-2 transmission rates and many foreign nationals were denied entry into the U.S. 

In December 2021, new travel policies went into effect requiring that all persons over the age of two entering the U.S. by air show proof of a negative COVID-19 test completed within one day of travel, regardless of vaccination status.  Testing requirements were lifted in June 2022.  Non-U.S. citizens and non-U.S. immigrants 18 years and older traveling to the U.S. by air were required to show proof of being fully vaccinated before boarding the airplane, with only limited exceptions.  Proof of vaccination for COVID-19 was also required for all non-U.S. citizens and non-U.S. immigrants 18 years and older for entry into the U.S. by land or ferry crossings, however, testing was not required.  On May 12, 2023, the CDC discontinued the proof of vaccination requirement for non-U.S. citizens and non-U.S. immigrants entering the U.S. by air. 

As of September 22, 2023, the CDC continues to recommends COVID-19 vaccination for all travelers. COVID-19 testing is also suggested for persons who develop symptoms of COVID-19 before, during, or after travel, if at a higher risk of exposure during travel, or if traveling to visit anyone considered to be at high risk for serious COVID-19 illness. 

 

COVID-19 in Children

While older adults and those with pre-existing medical conditions continue to be at a higher risk for severe disease, children remain at minimal risk of developing serious infection. Data has indicated that transmission of SARS-CoV-2 between children and from children to adults occurs infrequently  and in the U.S., children under the age of 14 have accounted for only 0.00035 of one percent of COVID-19 deaths.  Nationwide through September 20, 2023, the CDC reports that there have been 2,320 deaths attributed to COVID-19 in children ages 0-17. 

Schools, which closed in response to the pandemic, have reopened. Reopening, however, varied by state and school districts, with some school districts opting to provide only virtual schooling options for the 2021/2022 school year.  Many schools that were open during the pandemic imposed social distancing guidelines, facemask requirements, and additional cleaning protocols.  

In February 2021, CDC Director Dr. Rochelle Walensky publicly stated that schools could re-open safely for in-person learning by following guidelines that include social distancing, mask wearing, hand-washing, and contact tracing. Health officials reported that in-person learning did not increase community infection rates, and transmission of the virus between students rarely occurs.  The need to keep schools open during the increase in COVID-19 cases related to the Omicron variant was also emphasized by the White House in January 2022. 

In August 2022, the CDC revised their school recommendations and stated that school children exposed to COVID-19 would no longer need to quarantine or test to remain in school. 

A meta-analysis conducted in 2021 reported that children who developed COVID-19 had a 99.9973 percent chance of survival.  Additional studies have also concluded that children, especially those without co-morbidities, rarely suffer serious COVID-19 illness.   

In late December 2021, Dr. Anthony Fauci admitted that most COVID-19 positive hospitalization in children involved cases where the admissions were related to other causes.  The CDC also acknowledged in early January 2022 that they had not seen an increase in severe COVID-19 cases in children related to the Omicron variant. They also reported that most children were hospitalized with COVID-19 and not because of COVID-19. 

In April 2022, the CDC reported that by February 2022, 75 percent of children had COVID-19 antibodies. 

 

Cases and Deaths in 2020-2021

As of September 22, 2023, there have been over one hundred million cases and over 1.1 million COVID-19 related deaths reported in the US.  This data, however, includes both confirmed and probable cases. 

According to the CDC’s August 5, 2020 interim case definition for Coronavirus Disease 2019 (COVID-19), a confirmed COVID-19 case is one where laboratory evidence indicates the presence of the SARS-CoV-2 virus by a molecular amplification test  such as reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) or nucleic acid amplification test (NAAT). 

A probable COVID-19 case is a case where a person meets the clinical criteria for COVID-19 illness based on at least one symptom and the individual is also epidemiologically linked to another confirmed or probable case. The criteria for epidemiological linkage include close contact with a confirmed or probable case of COVID-19 disease or else being considered at risk based on criteria defined by public health officials during an outbreak. Probable cases are also cases confirmed by antigen testing, a rapid test considered less sensitive and not as reliable as molecular amplification tests.   

COVID-19 death counts also include both confirmed and probable cases. The CDC’s August 5, 2020 interim case definition for Coronavirus Disease 2019 (COVID-19) counts all deaths as a COVID-19 when the death certificate lists COVID-19 disease or SARS-CoV-2 as an underlying cause of death. Probable deaths are those where the death certificate list COVID-19 even without laboratory evidence to confirm the presence of the SARS-CoV-2 virus. 

In early April 2020, Dr. Deborah Birx, the former response coordinator for the White House coronavirus task force, reported that all deaths that occurred in SARS-CoV-2-positive individuals would be counted as a COVID-19 death regardless of whether the virus was responsible. As a result, the CDC’s data does not differentiate between persons who died as a direct result of COVID-19 illness and those who died from other causes but who tested positive for SARS-CoV-2. 

According to data released by the CDC in early September 2020, 94 percent of COVID-19 deaths occurred in persons with significant underlying health conditions. On average, there were 2.6 additional conditions or causes per COVID-related death. The most common respiratory conditions listed included influenza, pneumonia, respiratory failure, and adult respiratory distress syndrome. Comorbid circulatory diseases included hypertension, cardiac arrest, ischemic heart disease, heart failure, and cardiac arrhythmia. Approximately 16 percent of the death certificates listed diabetes, and 11 percent stated that vascular and unspecified dementia contributed or was the cause of death. Three percent had intentional or unintentional injury, poisoning or other type of adverse event listed. 

COVID-19 mortality rates have decreased since the beginning of the pandemic. One study published in October 2020 in the Journal of Hospital Medicine that involved 5,000 patients within New York’s Langone Health System reported an 18 percent mortality rate decrease between March and August 2020. Persons over the age of 75 years had the largest decrease in death rates, from nearly 45 percent in March to just under 10 percent in August. 

A study conducted by the Alan Turing Institute in the United Kingdom reported similar findings over the course of their research period, between March 1 and May 30, 2020. Researchers attribute the decrease in mortality rates to the introduction of effective treatment options and the decline in cases that require critical care interventions. 

 

The Great Barrington Declaration

On October 6, 2020, an international coalition of scientists, doctors and medical professionals created and signed a document expressing grave concern regarding the potential negative repercussions of lockdown measures imposed by governments in the wake of COVID-19 and called for a global policy change to what they call focused protection.152 The document, entitled The Great Barrington Declaration (GBD), was named for the Massachusetts town where organizers gathered and in which the petition was signed.153

The creators of the GBD expressed concerns that “current lockdown policies are producing devastating effects on short and long-term public health,” including fewer healthcare screening visits, worse outcomes for cardiovascular disease and other pre-existing conditions, and serious effects on mental health. Stating that vulnerability to death from COVID-19 is more than a thousand-fold higher in the old and infirm than the young and further, that for children, COVID-19 is less dangerous than many other harms, including influenza, the authors recommended that measures be put in place to protect vulnerable segments of society, while allowing all others to immediately return to normal life.154

Specifically, they suggested that nursing home staff be limited to those with acquired immunity, staff rotations minimized and staff and visitors frequently tested. Groceries and other essentials should be delivered to elderly who live in the community and the vulnerable should interact with people outside whenever possible. For everyone else, the authors recommended that:155

  • businesses and restaurants should open fully;
  • schools and universities should immediately reopen for in-person attendance, and offer all extracurricular activities;
  • sports, art, music, and other group events should resume; and
  • young low-risk adults should return to work instead of working from home.

Dr. Fauci and former NIH Director Dr. Francis Collins, however, called the authors fringe scientists and reported that if public health officials had followed the recommendations made in the GBD, more infections, hospitalizations, and deaths would have occurred.156

Rationale for Lockdowns Questioned

In mid-October 2020, the WHO’s Special Envoy, Dr. David Nabarro, stated that lockdowns should not be used as the primary method to control COVID-19 outbreaks. Dr. Nabarro noted that lockdowns will increase poverty and hunger globally and that it is likely that within a year, child malnutrition and poverty will double. Additionally, a study conducted in May 2020 reported that the anxiety and stress of lockdowns will likely “destroy seven times the years of life that lockdowns potentially save.” 

In January 2021, the European Journal of Clinical Investigation published a peer-reviewed paper conducted by Stanford University researchers that reported that their study failed “to find an additional benefit of stay-at-home orders and business closures." 

In an interview aired on May 20, 2021, former White House COVID-19 advisor, Dr. Scott Atlas, called the COVID-19 associated lockdowns a “heinous abuse of power” and did nothing to protect the most vulnerable populations at risk for the illness. Atlas criticized the response of public health officials, and stated that:

“the lockdowns failed, they still failed to protect the people who are high risk, and the lockdowns destroyed and killed. Many other people destroyed families, sacrificed our children out of fear for adults—even though the children do not have significant risk. And we didn’t care as a country. We kept them out of school.” 

The CDC reported that from March 2020 to March 2021, 96,779 drug overdoses occurred in the United States, an increase of nearly 30 percent from one year prior and was noted to be the largest single year increase ever in the U.S. National Institute on Drug Abuse Director Dr. Nora Volkow noted that the COVID-19 pandemic had "created a devastating collision of health crises in America."  The US reported a record number of drug overdoses in 2022, with 109,680 drug related deaths reported. 

More than 400 published studies have reported on the failure of COVID-19 lockdown and masking policies to slow transmission or reduce deaths.  A review of the available literature and a meta-analysis on the effects of lockdowns on COVID-19 mortality conducted by the Johns Hopkins Institute for Applied Economics, Global Health, and the Study of Business Enterprise published in January 2022 reported that the lockdowns in the U.S. and Europe reduced mortality rates by only 0.2 percent on average. Shelter in place orders were reported to have only reduced mortality rates by 2.9 percent. Non-pharmaceutical interventions were reported to have no noticeable effects on reducing COVID-19 mortality. 

 

Emergence SARS-CoV-2 Variants

In the fall of 2020, public health officials reported that multiple variants of the SARS-CoV-2 virus had emerged and were circulating worldwide. Like all viruses, SARS-CoV-2 continually evolve because genetic mutations happen during the genome’s replication. A variant is the result of one or more genetic mutations. 

In the United Kingdom, the B.1.1.7 variant (Alpha) emerged in September 2020, and by January 22, 2021 it was confirmed as the dominant circulating strain in England. The transmissibility of this variant was reportedly greater than other circulating SARS-CoV-2 virus variants.  Health officials reported that this variant appeared to be 30 to 80 percent more transmissible and increased a person’s risk of death by 30 percent.   

The B.1.351 variant (Beta) was initially detected in Nelson Mandela Bay in South Africa in early October 2020. By December 2020, this variant was found to be the predominant variant circulating in Zambia. 

The P.1.(Gamma) variant was first detected in Japan in four travelers from Brazil. In late December, 42 percent of positive samples collected in Manaus, the largest city in the Amazon region of Brazil, were the P.1. variant. Public health officials expressed concerns that this variant could be transmitted more effectively or be responsible for re-infection. 

On February 11, 2021, the Journal of the American Medical Association (JAMA) published a letter from researchers reporting on a novel SARS-CoV-2 variant, the CAL.20C variant (now B.1.427/B.1.429 or Epsilon), that had emerged in late 2020 in Southern California. By mid-January 2021, this variant was found to account for 35 percent of SARS-CoV-2 specimens from California, and 44 percent of specimens from Southern California.   

Another variant, the B.1.526 (Iota) variant, was identified by research teams from Columbia University and the California Institute of Technology (CalTech). Both teams of researchers found that the strain was detected in New York in November 2020 and that the variant may represent an antigenic drift in the virus with possible blunting of current vaccine effectiveness.   

On May 4, 2021, the CDC classified the SARS-CoV-2 variant B.1.617 (Delta) as a variant of interest.  This variant, which originated in India, was declared a variant of concern by the World Health Organization (WHO) on May 10, 2021. According to the WHO, the Delta variant was associated with increased transmissibility and decreased neutralization. As a result, vaccinated individuals and persons who have previously recovered from a COVID-19 infection could be at risk for infection from this variant. 

By the end of June 2021, almost 90 percent of COVID-19 cases in Israel were reported as being from the Delta variant, with 50 percent occurring in fully vaccinated adults.  Health experts reported the Delta variant to be more easily transmissible and that vaccinated individuals were capable of spreading the virus on to others, as COVID-19 vaccines were unable to stop viral transmission. 

The C.37 variant (Lambda), first identified in Peru in August 2020, was classified by WHO as a Variant of Interest on June 14, 2021.  The Lambda variant was reported to be highly contagious and more resistant to vaccines. 

On August 30, 2021, WHO designated the Mu variant a Variant of Interest.  Initially identified in Columbia in January 2021, this variant, also known as B.1.621, became increasingly prevalent in South America. WHO reported that "the Mu variant has a constellation of mutations that indicate potential properties of immune escape," but stated that further studies were needed on the variant. 

Resurgence of Cases related to the Omicron Variant

The B.1.1.529 variant (Omicron), which was initially identified in early November 2021 in South Africa, was labeled a Variant of Concern by WHO on November 26, 2021. According to WHO, the variant was concerning because it contained a significant number of mutations.  Many countries, including the U.S., announced that travel restrictions from eight African countries would be implemented by the end of November 2021 in an attempt to curb spread of the new variant.  Top South African health officials reported that while the variant appeared to be highly transmissible, symptoms were “extremely mild”. 

In late November 2021, health officials declared the Omicron variant a Variant of Concern. By December of 2021, health officials reported that cases associated with the variant would surge to record numbers and likely peak in mid-January 2022.  The variant, however, has been associated with lower rates of hospitalization, shorter in-patient stays, and lower fatality rates. 

As of August 27, 2023, the Omicron variant continues to be labeled a Variant of Concern by the CDC. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can COVID-19 Cause Injury and Death?

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Yes, COVID-19 can cause injury and death. By August 2023 the CDC had reported over 1.1 million COVID-19 related deaths.  This data, however, includes both confirmed and probable cases. As early as 2020, the White House coronavirus task force reported that all deaths that occurred in SARS-CoV-2-positive individuals would be counted as a COVID-19 death regardless of whether the virus was responsible. As a result, the CDC’s data did not differentiate between persons who died as a direct result of COVID-19 illness and those who died from other causes but who tested positive for SARS-CoV-2.   

COVID-19 mortality rates have decreased since the beginning of the pandemic that may in part be attributed to effective treatment and fewer cases requiring critical care interventions.   

COVID-19 Injuries

Most people who become infected with SARS-CoV-2 will have mild symptoms and fully recover;  however, COVID-19 can have serious complications that lead to adverse health outcomes and death. 

Many complications may be caused by a condition known as a cytokine storm. This occurs when an infection triggers the immune system to flood the bloodstream with inflammatory proteins referred to as cytokines, which can damage organs and kill tissue.  Complications of COVID-19 disease include pneumonia; acute respiratory distress syndrome (ARDS); acute kidney, liver, and heart failure or damage; septic shock; disseminated intravascular coagulation (DIC); rhabdomyolysis (muscle breakdown); chronic fatigue syndrome; blood clots and death. 

Additionally, Multisystem Inflammatory Syndrome in Children (MIS-C) is under investigation in relation to COVID-19 and it is not known what causes this condition. However, many children who develop this condition have been previously exposed to SARS-CoV-2. MIS-C is a condition where various organs of the body become inflamed. Symptoms of the syndrome can include neck pain, rash, diarrhea, vomiting, red eyes, excessive fatigue, and abdominal pain. 

Adults may also be at risk for developing a similar condition to MIS-C, known as Multisystem Inflammatory Syndrome in Adults (MIS-A), days to weeks following SARS-CoV-2 infection. Symptoms are similar to those found in children, but may also include low blood pressure and chest pain. The CDC states that they still do not know what triggers this conditions and report that they are continuing to research the syndrome. 

It is reported that about 2 percent of individuals who recover from COVID-19 may also experience debilitating symptoms which include shortness of breath, nausea, diarrhea, racing heart, intermittent high fever, as well as neurological problems such as memory loss, “brain fog”, and attention problems and is termed “long-COVID”.    The median age for this condition is 45 and women appear to carry the burden of this condition. 

There are no tests to confirm a diagnosis of long COVID and the CDC reports that some people with symptoms of long COVID have had no prior history of a COVID-19 infection or positive COVID-19 test. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who is at Highest Risk for Getting SARS-CoV-2 and COVID-19 Illness?

covid-19

Persons considered most at risk for severe illness include those with cardiovascular disease, hypertension, cerebrovascular disorders, cystic fibrosis, pulmonary fibrosis, liver disease, Downs Syndrome, dementia and neurological disorders, chronic obstructive pulmonary disease (COPD), type 1 and type 2 diabetes mellitus, chronic kidney disease, cancer, sickle cell disease, thalassemia, and those who are immunocompromised due to solid organ transplant, HIV, immune deficiencies, blood or bone marrow transplant, or those taking medications that suppress the immune system. Persons who are obese (body mass index of 30 or higher), pregnant, smokers, including current and former smokers, and persons with substance use disorders are also considered to be at a higher risk of developing severe illness. 

Also at risk for developing COVID-19 are front-line health care workers treating SARS-CoV-2 infected patients. Individuals who work outside the home and in positions that require contact with the public are also at an increased risk of infection. Additionally, persons who require personal care from others such as those who are aged or disabled are also at an increased risk. 

Minorities are considered to be at an increased risk of COVID-19, including severe illness. However, no biological mechanism has been identified and health official report that a lack of health insurance and limited access to health care are likely responsible for this increased susceptibility. Moreover, a higher percentage of minorities may work in public settings which also places them at a higher risk of illness.  Many rely on public transportation and live in crowded apartments, which increases their risk of exposure. 

According to the National Academies of Sciences, Engineering, and Medicine: 

“People of color — specifically Black, Hispanic or Latinx, and American Indian and Alaska Native — have been disproportionately impacted by COVID-19 with higher rates of transmission, morbidity, and mortality. Currently there is little evidence that this is biologically mediated, but rather reflects the impact of systemic racism leading to higher rates of co-morbidities that increase the severity of COVID-19 infection and the socioeconomic factors that increase likelihood of acquiring the infection, such as having front line jobs, crowded living conditions, lack of access to personal protective equipment, and inability to work from home.”

Persons experiencing homelessness are also thought to be at a greater risk due to frequent close contact with others in shelters and on the streets. 


IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who is at Highest Risk for Complications from SARS-CoV-2 and COVID-19?

covid-19

Persons considered most at risk for developing complications from COVID-19 include those with cardiovascular disease, hypertension, cerebrovascular disorders, cystic fibrosis, pulmonary fibrosis, liver disease, Downs Syndrome, dementia and neurological disorders, chronic obstructive pulmonary disease (COPD), type 1 and type 2 diabetes mellitus, chronic kidney disease, cancer, sickle cell disease, thalassemia, and those who are immunocompromised due to solid organ transplant, HIV, immune deficiencies, blood or bone marrow transplant, or those taking medications that suppress the immune system. 

Persons who are obese (body mass index of 30 or higher), pregnant, smokers, including current and former smokers, and persons with substance use disorders are also considered to be at a higher risk of developing severe illness. 

The CDC also states that the risk of hospitalization and death increases with age, and that individuals over the age of 85 are at the greatest risk of developing severe illness. 

Severe Illness Risk Factors for Minorities

In the U.S., African Americans and individuals of Asian, Hispanic and Native American descent have been disproportionally affected by SARS-CoV-2, with higher rates of COVID-19 illness and death reported in comparison to white Americans.      Research has also found that hidden biases exist in health care that prioritizes white Americans over African Americans. 

However, African Americans also have higher rates of underlying chronic illness including diabetes, hypertension, and heart disease, which are known to increase a person’s risk of developing SARS-CoV-2 complications. Many African Americans are also critical front-line workers, which may also increase rates of infection within the African American population.   

Ethnic and racial minorities are known to have less access to health care services and often less likely to have adequate health insurance. As a result, they may not seek prompt treatment for symptoms, which places them at higher risk of hospitalization and death if initial care begins at a later point in the disease process. 

Additionally, higher rates of illness among racial and ethnic minorities in the U.S. has been attributed to lower socioeconomic status among these populations, rather than a predisposition to the illness. Many African Americans, Hispanics, and persons of Native American descent are more likely to reside in crowded conditions, in multigenerational households, be employed in positions that can’t be performed remotely, and use public transportation. As a result, they are more likely to be exposed to the SARS-CoV-2 virus. 

Individuals who are not proficient in English, particularly those who lack an understanding of health literacy, have also been noted to have poorer COVID-19 health outcomes. Experts report that information provided by public health officials is not adequately communicated and distributed to these populations, placing them at higher risk of severe outcomes. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

 

SARS-CoV-2 and COVID-19 Prevention and Treatment Options

covid-19

Prevention

Avoiding exposure to the SARS-CoV-2 virus is the best way to prevent illness. Staying away from individuals who are ill or who may have been exposed to the virus can reduce your risk of contracting the virus. 

Washing hands with soap and water or using an alcohol-based hand sanitizer when handwashing facilities are not available can also be effective in reducing infection risk.  A study published in the American Journal of Preventive Medicine in December 2022 found that exercise reduced the risk of severe COVID-19 outcomes, with researchers recommending that public health officials “add physical activity to pandemic control strategies.”   

 

Evidence Base for Masks

While the CDC continues to promote the use of masks as a method to reduce the risk of viral transmission, and report that consistently wearing a well-fitted mask is better than not wearing one,  multiple studies, have found that masks show little or no benefit, and may potentially cause harm.          

In January 2023, the Cochrane Library published a review on the available literature pertaining to the use of physical interventions to reduce the spread of respiratory viruses. The authors concluded that wearing medical/surgical masks in community settings offered little to no protection against influenza-like illness and COVID-19. Additionally, the authors also found that when compared to surgical/medical masks, N95 and P2 respirators likely offered little to no additional protection against respiratory illness. 

There are also several studies finding that there are harms associated with masking, such as exposure to dangerous levels of carbon dioxide,     fatigue or drowsiness, headaches, concentration impairments, irritability, malaise, impairments in learning, depressed moods, and a reluctance to attend school. 

 

Vitamin D and Severe COVID-19 Illness

Individuals who are deficient in vitamin D have been found to be at an increased risk of severe COVID-19 disease.    In addition to strengthening teeth and bones, vitamin D supports nervous, brain and immune system health, lung and cardiovascular function and regulates insulin levels.

A 2021 large-scale observational study revealed that high vitamin D levels may be protective against COVID-19 and noted that while the recommended dietary allowance for vitamin D is 600 to 800 international units (IUs) per day, the National Academy of Medicine states that up to 4,000 IUs per day is safe for the majority of people.  Another 2021 study found that persons with low vitamin D levels were at higher risk of serious disease, increased intensive care unit stays, and death.  Ensuring adequate vitamin D levels may prevent a person from developing serious COVID-19 illness.       

 

Additional Nutritional Information

A review published in May 2020  stated that while there were no published nutrition studies specific to COVID-19 and SARS-CoV-2, there was evidence from acute respiratory distress syndrome in other clinical settings that demonstrated that n-3 fatty acids EPA and DHA can help control the cytokine storm. Study authors stated that while this therapeutic treatment protocol had not been tried in the treatment of severe COVID-19, it might be something to consider.

The review also stated that in general, vitamins A, B6, B12, C, E, folate and trace minerals such as iron, zinc, selenium, and copper are vital in reducing the risk of infections and supporting immune function. Ensuring a healthy diet containing these essential vitamins and minerals, or supplementing when dietary sources are inadequate, may be helpful in preventing illness. This review also noted that gut health was important in maintaining a healthy immune system and that consuming fermented foods and a diet rich in fiber could help to maintain a healthy gut microbiota. 

 

Treatments

According to the CDC, most people who become ill with COVID-19 will not require any specific treatment, with over-the-counter fever and pain reducers to relieve aches and pains associated with illness advised.  Ensuring adequate hydration and rest are also considered important for recovery. 

The CDC also recommends that individuals with one or more underlying health conditions contact a health care provider immediately following a positive COVID-19 test to discuss treatment and intervention options. 

FDA Approved Treatments

Vekluky (Remdesivir)

The FDA has approved Remdesivir for use in COVID-19 patients 28 days of age and older and who weigh at least 3 pounds. Remdesivir, an antiviral medication administered intravenously, must be given in an acute care setting such as a hospital or similar facility.  This drug, initially approved for use under EUA in May 2020, received FDA approval for use in SARS-CoV-2 positive hospitalized individuals aged 12 years and older and weighing at least 40 pounds in October 2020.  The FDA has since expanded its approval of the drug to include children as young as 28 days of age, and for use in outpatient settings, for the treatment of mild to moderate COVID-19 illness. 

Approval for the use of Remdesivir in infants and young children was based on an open label study of only 53 children, with no placebo control. In this study, 72 percent of children suffered adverse events, but 21 percent of these serious adverse events were considered by the investigators to be unrelated to the medication. Three children died during the study, from either COVID-19 or a pre-existing condition. 

In 2020, the World Health Organization (WHO) reported that preliminary results of a larger international study found that Remdesivir “appeared to have little or no effect on hospitalized COVID-19.”  Additionally, the European Society of Intensive Care Medicine stated in 2020 that Remdesivir should not be used routinely in COVID-19 patients.  In 2021, the Journal of the American Medical Association (JAMA) concluded that 

“remdesivir treatment was not associated with improved survival but was associated with longer hospital stays. Routine use of remdesivir may be associated with increased use of hospital beds while not being associated with improvements in survival.”

The Lancet similarly concluded later in 2021 that: 

“No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support.”

Paxlovid (Nirmatrelvir/ritonavir)

In May 2023, the FDA approved Paxlovid, an oral anti-viral medication, for the treatment of mild-to-moderate COVID-19 in adults considered at high risk for developing severe COVID-19 illness. The drug manufactured and packaged under EUA, however, will continue to be made available under EUA to adults and to children aged 12 through 17 years of age not covered by the FDA approval. 

Paxlovid, manufactured by Pfizer, initially received approval under EUA for use in SARS-CoV-2 positive children aged 12 years and older considered at high risk for severe disease, to be given as soon as a diagnosis is made and within five days of symptom onset. 

Side effects of the medication include diarrhea, impairment of taste, high blood pressure, and muscle aches. One of the components of Paxlovid, Ritonavir, can cause liver damage. This medication may also lead to HIV-1 drug resistance in persons with undiagnosed or uncontrolled HIV-1. The medication is not recommended for use in persons with kidney or liver disease. According to the FDA, an analysis of the medication in 1,039 individuals reported a 0.86 fatality rate in persons who received Paxlovid, compared to the placebo group (1,046 individuals) that reported a 6 percent death rate. Studies on the medication are ongoing.  Paxlovid has the potential to cause severe or life-threatening reactions if taken with common medications such as antidepressants, anticoagulants, and statins. 

A case study published in September 2022 suggested that individuals treated with Paxlovid may experience COVID-19 rebound infections.  This information prompted the CDC in 2022 to issue an emergency alert to health care providers regarding the risk of “rebound” COVID-19 infection in individuals treated with Paxlovid. The alert stated that additional treatment with Paxlovid was not recommended and those experiencing a relapse in symptoms should re-isolate for at least five days and wear a mask for at least ten days.  During 2022, several individuals, including Dr. Anthony Fauci,  President Joe Biden,  and First Lady Jill Biden  reported rebound COVID-19 infection after taking Paxlovid.

In late April 2022, Pfizer announced that Paxlovid did not prevent symptomatic COVID-19 illness in household contacts of persons who took the medication. 

 

Emergency Use Authorization (EUA) Treatments

Emergency Use Authorization (EUA) is a status given to experimental and licensed products by the FDA during a public health emergency, as defined under federal law.   

Monoclonal Antibodies

In 2020, the FDA issued EUAs for several monoclonal antibodies to treat COVID-19. Monoclonal antibodies are laboratory produced synthetic versions of antibodies and included the drugs baricitinib,  bamlanivimab,    casirivimab,  imdevimab,  etesevimab,   sotrovimab,   and bebtelovimab.  In 2021, Evusheld, a long-acting COVID-19 preventative monoclonal antibody received EUA status by the FDA for persons 12 years and older considered immunocompromised or for those unable to receive a COVID-19 vaccine. 

By December 2022, however, health officials reported that monoclonal antibodies were no longer an effective treatment against the circulating SARS-CoV-2 strains found in the U.S.  As of August 27, 2023, all EUAs for monoclonal antibodies targeting the SARS-CoV-2 virus have been revoked. 

Anti-Viral Medications

In December 2021, the FDA issued an EUA for Molnupiravir, an oral anti-viral, for the treatment of mild to moderate COVID-19 illness in SARS-CoV-2 positive adults considered at high risk for severe COVID-19 illness, including hospitalization and death when other FDA authorized treatments are not available or appropriate. 

Molnupiravir, manufactured by Merck, is authorized for use in adults 18 years and older for the treatment of COVID-19 illness who are positive for SARS-CoV-2 and at risk of severe illness. According to clinical trials, of the 709 individuals who received molnupiravir, 6.8 percent required hospitalization compared to 9.7 percent of the 699 individuals who received the placebo. One person who received molnupiravir died, compared to nine people who received the placebo. This experimental medication is not recommended for use in pregnant women because animal reproductive studies appear to indicate a risk of fetal harm. Reported side effects include diarrhea, nausea, and dizziness. 

Some scientists have expressed concern about Molnupiravir because it is capable of mutating RNA and could potentially cause new and possibly deadlier virus variants.61

 

Additional Treatments for COVID-19

High doses of vitamin C given intravenously (IV) have been used to treat COVID-19. Three clinical trials and several smaller studies reported successful outcomes among patients who received IV vitamin C at doses varying from 50 to 200 milligrams per kilogram of body weight to up to 200 mg per kg per day. 

One study published in March 2020 reported:

“High-dose intravenous VC has also been successfully used in the treatment of 50 moderate to severe COVID-19 patients in China. The doses used varied between 10 g and 20 g per day, given over a period of 8–10 h. Additional VC bolus may be required among patients in critical conditions. The oxygenation index was improving in real time and all the patients eventually cured and were discharged.”  

The Frontline COVID-19 Critical Care Alliance (FLCCC), a group comprised of highly published critical care experts, created a protocol to treat hospitalized COVID-19 patients. In 2021, the FLCCC’s clinical and scientific rationale on their methylprednisolone, ascorbic acid (vitamin C), thiamine, heparin and co-interventions (MATH+) protocol was peer reviewed and published in Journal of Intensive Care Medicine.  The protocol was reported as effective in the treatment of severe COVID-19 illness requiring hospitalization. Additional treatment co-interventions noted in the research article included the use of melatonin, famotidine, atorvastatin, vitamin D3, and the application of therapeutic plasma exchange (a treatment that replaces an individual’s blood plasma). 

The article noted that systematic use of MATH+ in two U.S. hospitals demonstrated an absolute mortality risk reduction of more than 75 percent, or 5.1 percent vs. 22.9 percent, when compared to multiple published COVID-19 hospital mortality rates in the U.S. The article concluded:

“It is exceedingly unlikely that a “magic bullet” will be found, or even a medicine which would be effective at multiple stages of the disease. The Math+ treatment protocol instead offers an inexpensive combination of medicines with a well-known safety profile based on strong physiologic rationale and an increasing clinical evidence base which potentially offers a life-saving approach to the management of COVID-19 patients.”  

 

FDA Approved Drugs Used Off-Label to Treat COVID-19

Because the SARS-CoV-2 virus was new, there were no FDA approved drugs specific to this new virus. This resulted in some health care professionals using their clinical experience to treat COVID-19 symptoms using existing FDA approved drugs off-label.

According to the FDA’s website on understanding the use of off label drugs, “once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” The FDA’s website also states that the reason for off-label usage of a drug can stem from no approved drug exists to treat the patient’s condition, to drugs that have been approved may not be working for the patient.  The U.S. Department of Health and Human Services has stated that off label drug use is very common and that one in five drug prescriptions written are for off-label use. 

Hydroxychloroquine and Chloroquine

Controversy over the off-label use of hydroxychloroquine and chloroquine for COVID-19 continues today. These anti-malaria drugs received emergency use authorization from the FDA in March of 2020, based on laboratory studies that showed these medications to be effective against coronaviruses. However, the FDA revoked the EUA for hydroxychloroquine in mid-June 2020, stating that the medication was ineffective against COVID-19 and potentially harmful. 

The World Health Organization (WHO) halted their hydroxychloroquine drug trials after May 2020 study reported that hydroxychloroquine was not effective against COVID-19 and was associated with heart arrhythmias and higher death rates. The validity of this study was immediately questioned and when the study data could not be obtained for independent review, study was retracted. 

In June 2020, scientists affiliated with the Henry Ford Hospital System published research on hydroxychloroquine that indicated that the drug was effective in reducing the COVID-19 death rate, improved outcomes with early treatment, with no heart-related side effects were reported.  These findings, however, have been criticized by health officials including Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID). 

Hydroxychloroquine administered in combination with zinc and azithromycin has also been reported to be an effective treatment for hospitalized COVID-19 patients. 

A January 2021 published study in the American Journal of Medicine reported that when the medicine was administered early in the treatment stage, it was effective at halting disease progression, preventing hospitalization, and reducing mortality rates. This study also reported the effectiveness of using the hydroxychloroquine in combination with either azithromycin or doxycycline, two commonly prescribed antibiotics. 

Ivermectin

FDA approved to treat parasites, the drug ivermectin has been found to inhibit SARS-CoV-2, the virus that causes COVID-19, in vitro.  Australian gastroenterologist Dr. Thomas Borody, known for developing the first peptic ulcer cure, reported that ivermectin administered in conjunction with zinc and the antibiotic doxycycline could be a ‘potential life-saver.’  A January 2021 published study reported that the use of ivermectin was associated with lower rates of death, especially in patients who had severe pulmonary involvement.  A journal study published in April 2021 concluded that: 

“Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.”

The FDA has not approved the use of ivermectin for SARS-CoV-2. Further, in 2021 the CDC issued a health advisory regarding the use of ivermectin as a treatment option for COVID-19 and noted it was not approved or authorized as a COVID-19 treatment and warned against its use. 

Multiple studies have found ivermectin to be effective in treating COVID-19 illness, preventing hospitalization, and reducing mortality.   

Budesonide

The corticosteroid Budesonide, commonly used to treat asthma symptoms, has also been successfully used off-label to treat COVID-19 symptoms. A University of Oxford study showed budesonide significantly decreased urgent care visits and hospitalizations, and shorter recovery time and duration of symptoms when used within seven days of symptom onset. 

Other FDA Approved Medications

Additional medications used off-label demonstrating effectiveness in the early treatment options for COVID-19 illness include fluvoxamine,       a medication typically used to treat depression, and fenofibrate, a medication used to decrease cholesterol.    

 

Convalescent Plasma

In early August 2020, Mayo Clinic researchers reported that blood plasma donated from individuals who had recovered from COVID-19, was helpful despite a lack a formal data to support its use.  In October 2020, a study on the use of convalescent plasma to treat moderate COVID-19 illness in adults reported that this treatment was not effective in reducing the progression to severe disease or preventing COVID-19 related deaths.  In 2021, the FDA revised the authorization for convalescent plasma and limited its use to high-titer convalescent plasma for early treatment of hospitalized patients or in persons with impaired humoral immunity who are unable to produce an adequate antibody response. Low-titer convalescent plasma was declared ineffective and its use was no longer authorized. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is COVID-19 vaccine?

There are two COVID-19 vaccines licensed and recommended in the U.S. by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC). Comirnaty,  an mRNA vaccine developed and produced by Pfizer- BioNTech and SPIKEVAX,  an mRNA vaccine developed and manufactured by Moderna with the National Institutes of Allergy and Infectious Disease (NIAID). Both vaccines are approved for use in persons 12 years of age and older.

Messenger RNA (mRNA) vaccines are gene based vaccines that involve injecting lipid nanoparticles containing mRNA (genetic code) that enable the vaccine to get past the cell wall, into the intracellular space, then causes the cell’s ribosome to make viral proteins (antigen that stimulate the immune system.)  In essence, an mRNA vaccine tricks the body into producing the viral proteins to trigger an immune response.  Messenger RNA vaccines can be produced in the lab using faster and less expensive processes than traditional vaccines. 

Additional COVID-19 Vaccines are available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines produced by Pfizer-BioNTech for use in infants and children aged 6 months through 4 years and for children five through 11 years of age  and one mRNA COVID-19 vaccine produced by Moderna for use in infants aged 6 months through 11 years.  There is one protein subunit vaccine, Novavax, authorized for use in individuals 12 years of age and older. 

 

Emergency Use Authorization (EUA)

According to the FDA, vaccine makers may submit an application to have their products approved under an Emergency Use Authorization (EUA). Under EUA authority, the FDA Commissioner may permit “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.”9 To learn more about EUA products and vaccines and consumer rights, visit NVIC’s FAQ on  Emergency Use Vaccines (EUA) & Vaccine Injury Compensation.

 

Comirnaty COVID-19 mRNA Vaccine (Age 12 and older)

In September 2023, the FDA approved an updated mRNA COVID-19 vaccine developed and manufactured by Pfizer-BioNTech for use in persons 12 years and older to target the Omicron variant XBB.1.5. 

Comirnaty COVID-19 mRNA Vaccine was initially authorized for use under EUA as Pfizer-BioNTech COVID-19 vaccine in persons 16 years and older by the in December 2020. This vaccine targeted the original SARS-CoV-2 virus and was authorized to be given as a 2-dose series.  In August 2021 the FDA licensed and granted EUA status to Comirnaty COVID-19 vaccine, an mRNA vaccine developed by BioNTech, for use in persons 16 years of age and older.  The FDA licensed Comirnaty for use in teens 12 through 15 years in July 2022.  In August 2022, the FDA authorized use of a bivalent Pfizer-BioNTech COVID-19 vaccine containing the original SARS-CoV2 strain and the Omicron BA.4/BA.5 variant. 

According to the Comirnaty COVID-19 vaccine package insert “The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.”  

Each 0.3mL dose contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2 Omicron Variant lineage XBB.1.5.

Additional vaccine ingredients include lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, 0.01 mg potassium chloride, and 6 mg sucrose. The 0.9 percent sodium chloride Injection diluent adds another 2.16 mg sodium chloride per dose. The vaccine does not contain a preservative and the vaccine vial stoppers are free of latex. 

The 2023-2024 Comirnaty COVID-19 vaccine is approved to be given intramuscularly (IM) as a single dose, at least two months after receipt of a previous COVID-19 vaccine dose. 

There is no data available on the co-administration of the Comirnaty COVID-19 Vaccine with any other vaccine product.  

Comirnaty COVID-19 vaccine may not offer protection to all individuals.   This vaccine is also incapable of reducing or stopping transmission of the virus. This means that vaccinated individuals may still be capable of transmitting the virus to others.   

Individuals with immunocompromising conditions, including those who take medications that induce immunosuppression may have a decreased immune response to Comirnaty COVID-19 vaccine.  

According the Comirnaty package insert, data on the safety and effectiveness of the vaccine for use in pregnant women is not known. It is also not known whether the vaccine can be transmitted through breastmilk.  

Comirnaty COVID-19 vaccine has not been studied for its potential to cause cancer, genotoxicity or male infertility. 

On September 12, 2023, the CDC’s ACIP voted to approve use of the 10mcg dose of the 2023-2024 Comirnaty COVID-19 mRNA vaccine targeting the Omicron variant XBB.1.5 in all persons aged 12 years and older. 

 

Pfizer – BioNTech mRNA COVID-19 Vaccine (Age 5 through 11 years)

In September 2023, the FDA issued an EUA for an updated Pfizer-BioNTech COVID-19 mRNA vaccine for use in children aged five through 11 years of age to target the Omicron variant XBB.1.5. 

The FDA initially authorized use of a 10-mcg dose of Pfizer-BioNTech mRNA COVID-19 vaccine to target the original SARS-CoV-2 strain for children 5 through 11 years of age in October 2021,  and an updated vaccine product containing the original SARS-CoV-2 variant and the Omicron BA.4/BA.5 variant in October 2022.  These previously authorized vaccine formulations are no longer available for use in the U.S. 

According to the Fact Sheet provided by the FDA, for 2023-2024, each 0.3 ml dose of Pfizer-BioNTech COVID-19 Vaccine contains 10mcg of nucleoside modified messenger RNA (mRNA) that encodes the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus targeting the Omicron variant XBB.1.5. 

Each dose also contains a total lipid content of (0.14 mg (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 0.02 mg 2[(polyethylene glycol)-2000- N,N-ditetradecylacetamide, 31 mg sucrose, 0.06 mg tromethamine, and 0.4 mg tromethamine hydrochloride. The vaccine also contains 0.9mg sodium chloride per dose. The vaccine vial stoppers are free of latex and the vaccine does not contain a preservative. 

The vaccine is recommended to be administered intramuscularly (IM). There is no data on the safety or effectiveness of administering the Pfizer-BioNTech COVID-19 vaccine with any other vaccine. 

Pfizer-BioNTech COVID-19 vaccine has not been studied for its potential to cause cancer, genotoxicity or male infertility. 

On September 12, 2023, the CDC’s ACIP voted to approve use of the 10mcg dose of the Pfizer-BioNTech 2023-2024 COVID-19 mRNA vaccine targeting the Omicron variant XBB.1.5 in all children 5 through 11 years of age. 

 

Pfizer – BioNTech mRNA COVID-19 Vaccine (Age 6 months through 4 years)

In September 2023, the FDA granted an EUA for an updated Pfizer-BioNTech mRNA COVID-19 vaccine for use in children aged 6 months through 4 years of age to target the Omicron variant XBB.1.5. 

The FDA originally issued an EUA for a 3mcg dose of Pfizer-BioNTech mRNA COVID-19 vaccine containing the original SARS-CoV-2 strain for infants and young children aged 6 months through 4 years of age in June 2022,  and a bivalent booster dose containing the original SARS-CoV-2 and Omicron strains BA.4/BA.5 in December 2022.  These previously authorized vaccine formulations are no longer available for use in the U.S. 

According to the Fact Sheet provided by the FDA, each 0.3 mL dose of the vaccine contains 3mcg of nucleoside modified messenger RNA (mRNA) that encodes the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.  

Each dose also contains the following ingredients: 9.4 mg sucrose, 0.02 mg tromethamine, 0.12 mg tromethamine hydrochloride; lipids (0.04 mg ((4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.005 mg 2[(polyethylene glycol)-2000- N,N-ditetradecylacetamide, 0.01 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.02 mg cholesterol). The sterile 0.9 percent sodium chloride diluent adds 1.88 mg of sodium chloride per dose. The vaccine vial stoppers are free of latex and the vaccine does not contain a preservative. 

Children aged six months through four years are recommended to receive at least 3-doses of Pfizer-BioNTech mRNA COVID-19 vaccine. The number of recommended doses of the authorized 3mcg Pfizer-BioNTech COVID-19 vaccine targeting Omicron variant XBB.1.5 will depend on previously authorized doses of COVID-19 vaccine. 

Pfizer-BioNTech COVID-19 vaccine has not been studied for its potential to cause cancer, genotoxicity or male infertility. 

The CDC’s ACIP voted to approve use of the 3mcg dose of the Pfizer-BioNTech 2023-2024 mRNA COVID-19 vaccine targeting the Omicron variant XBB.1.5 for use in all children aged 6 months through 4 years of age on September 12, 2023. 

 

Spikevax mRNA COVID-19 Vaccine (Age 12 and older)

On September 11, 2023, the FDA approved an updated mRNA COVID-19 vaccine developed and manufactured by Moderna for use in persons 12 years and older to target the Omicron variant XBB.1.5. 

The Moderna mRNA COVID-19 vaccine containing the original SARS-CoV-2 virus was initially issued an EUA by the FDA in December 2020 for use in persons 18 years of age.  On January 31, 2022, the FDA licensed and granted EUA status to Moderna for SPIKEVAX COVID-19 vaccine for use in persons 18 years of age and older. The FDA also stated that use of SPIKEVAX and the experimental Moderna mRNA COVID-19 vaccine were interchangeable due to having the same formulation.  In August 2022, the FDA authorized use under EUA to Moderna for a bivalent COVID-19 vaccine containing the original SARS-CoV-2 virus and the Omicron BA.4/BA.4 variant in persons 18 years and older.  A bivalent COVID-19 vaccine was also authorized for use in adolescents aged 12 through 17 years in October 2022.  These previously authorized vaccine formulations are no longer available for use in the U.S. 

According to the SPIKEVAX COVID-19 vaccine package insert “The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.” 

Each 0.5 ml dose of SPIKEVAX 2023-2024 mRNA COVID-19 vaccine contains 50 mcg of nucleoside modified messenger RNA (mRNA) that encodes the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 Omicron variant lineage Omicron XBB.1.5. 

Each dose also contains a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG 2000 dimyristoyl glycerol [DMG, cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC), 0.25 mg tromethamine, 0.021 mg acetic acid, 1.2 mg tromethamine hydrochloride, 43.5 mg sucrose and 0.10 mg sodium acetate trihydrate. The vaccine does not contain a preservative and the vaccine vial stoppers are free of latex.  

The 2023-2024 SPIKEVAX COVID-19 vaccine is approved to be given intramuscularly (IM) as a single dose, at least two months after receipt of a previous COVID-19 vaccine dose. 

The duration of vaccine-acquired immunity from SPIKEVAX COVID-19 vaccine is not known. The vaccine offers only minimal protection against infection and transmission. This means that vaccinated individuals can still become infected with the virus and spread it on to others. 

There is no data available on the co-administration of the SPIKEVAX COVID-19 Vaccine with any other vaccine product.  

Individuals with immunocompromising conditions, including those who take medications that induce immunosuppression may have a decreased immune response to SPIKEVAX COVID-19 vaccine. 

According the SPIKEVAX package insert, data on the safety and effectiveness of the vaccine for use in pregnant women is not known. It is also not known whether the vaccine can be transmitted through breastmilk. 

SPIKEVAX COVID-19 vaccine has not been studied for its potential to cause cancer, genotoxicity or male infertility. 

On September 12, 2023, the CDC’s ACIP voted to approve use of the 50mcg dose of the 2023-2024 SPIKEVAX COVID-19 mRNA vaccine targeting the Omicron variant XBB.1.5 in all persons aged 12 years and older. 

 

Moderna COVID-19 Vaccine for Children (Ages 6 months through 11 years)

In September 2023, the FDA issued an EUA for an updated Moderna COVID-19 mRNA vaccine for use in children aged 6 months through 11 years of age to target the Omicron variant XBB.1.5. 

The FDA originally issued an EUA to Moderna in June 2022 for an mRNA COVID-19 vaccine containing the original SARS-CoV-2 virus for use in children ages 6 months through 11 years of age.  In October 2022, the FDA authorized use of a Moderna bivalent COVID-19 vaccine containing the original SARS-CoV-2 variant and the Omicron BA.4/BA.5 variant in children 6 through 11 years  and in infants and children aged 6 months through five years in December 2022.  These previously authorized vaccine formulations are no longer available for use in the U.S. 

According to the Fact Sheet provided by the FDA, each 0.25mL dose of Moderna COVID-19 mRNA vaccine contains 25 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 Omicron variant lineage XBB.1.5. 

Additional ingredients contained in the vaccine include 21.8 mg sucrose, 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and a total lipid content of 0.5 mg (SM-102, polyethylene glycol [PEG 2000 dimyristoyl glycerol [DMG, cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC). The vaccine does not contain a preservative and the vaccine vial stopper does not contain natural latex rubber. 

Children aged six months through four years are recommended to receive at least 2 doses of Moderna mRNA COVID-19 vaccine. The number of recommended doses of the authorized 25mcg Moderna COVID-19 vaccine targeting Omicron variant XBB.1.5 will depend on previously authorized doses of COVID-19 vaccine. Children aged five through 11 years are recommended to receive one dose of the 2023-2024 Moderna COVID-19 vaccine, at least two months after receipt of a previous COVID-19 dose.  

There is no data on the safety or effectiveness of administering the Moderna COVID-19 vaccine with any other vaccine. 

Moderna COVID-19 vaccine has not been studied for its potential to cause cancer, genotoxicity or male infertility. 

On September 12, 2023, the CDC’s ACIP voted to approve use of the 25mcg dose of the 2023-2024 Moderna COVID-19 mRNA vaccine targeting the Omicron variant XBB.1.5 in all children aged 6 months through 11 years. 

 

Novavax COVID-19 Vaccine (Age 12 and older)

In October 2023, the FDA issued an EUA to Novavax for its adjuvanted COVID-19 vaccine containing spike protein from the Omicron XBB.1.5 variant of SARS-CoV-2. 

The FDA initially issued an EUA to Novavax for an adjuvanted COVID-19 vaccine, for use in adults 18 years and older who had not received a prior dose of COVID-19 vaccine on July 13, 2022. The vaccine was authorized as a two-dose primary series, to be administered intramuscularly three weeks apart.  The EUA was expanded on August 19, 2022 to include adolescents aged 12 through 17 years.  The original Novavax COVID-19 vaccine is no longer authorized for use in the U.S. 

Maryland-based Novavax Inc, a biotechnology company which had never successfully delivered a product to market,  developed an experimental vaccine using recombinant nanoparticle technology. Referred to as a protein subunit vaccine,  NVX‑CoV2373 contains Novavax’s patented saponin-based Matrix-M™ adjuvant designed to enhance the immune response and stimulate high levels of neutralizing antibodies. 

Matrix-M1 contains nm (nanometers) of nanoparticles composed of Quillaja saponins, phospholipid and cholesterol. Quillaja saponins are chemical compounds extracted from the soapbox tree and are used as emulsifiers in food additives and beverages. 

According to the fact sheet for health care providers administering Novavax COVID-19 vaccine, each 0.5 mL dose of the Adjuvanted Novavax COVID-19 Vaccine contains 5 mcg of SARS-CoV-2 recombinant spike protein from the SARS-CoV-2 Omicron variant XBB.1.5 and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is made of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree (Quillaja saponaria Molina). The recombinant spike protein is made by recombinant DNA technology in an insect cell line that is derived from cells of the Spodoptera frugiperda species. 

Each 0.5mL dose of the Adjuvanted Novavax COVID-19 vaccine also contains the following ingredients: potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), cholesterol, phosphatidylcholine, sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg) and polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with either sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of the Novavax vaccine may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), Triton X-100 (< 0.025 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), and Tergitol (NP9) (< 0.05 mcg). The Adjuvanted Novavax COVID-19 vaccine does not contain preservative and the vial stoppers are not made with natural rubber latex.  

The Adjuvanted Novavax COVID-19 vaccine is authorized to be given as a single dose to individuals 12 years of age and older who have previously received a dose of COVID-19 vaccine. Individuals who have not received any COVID-19 vaccines are recommended to receive two doses of adjuvanted Novavax COVID-19 vaccine at least three weeks apart. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is the history of COVID-19 vaccine use in America?

vaccine history

Immediately after the January 30, 2020 WHO declaration that a novel coronavirus (SARS-CoV-2) outbreak in China posed a “public health emergency of international concern,” the Gates Foundation  and World Health Organization (WHO)  issued press releases informing the world that experimental coronavirus vaccines already in development would be put on a fast track to licensure for global use.

A research and development plan published by WHO stated there was an “urgent need” to fill in scientific knowledge gaps about the “basic biology” of COVID-19 illness and clinical evolution of COVID-19 and its epidemiology, as well as the need to develop appropriate animal models for research because some previous SARS and MERS vaccine studies in animals showed enhanced respiratory disease can occur in vaccinated animals after exposure to the live virus. 

 

Vaccine Development Hampered by Enhanced Respiratory Disease

For the past two decades, coronavirus vaccine research has been hampered by one consistent vaccine adverse outcome in particular - paradoxical immune enhancement (antibody disease enhancement). This outcome has not only been observed in SARS-CoV-1 and MERS-CoV vaccines, but also with vaccines using formalin-inactivation for measles (this vaccine was withdrawn in 1967) and respiratory syncytial virus (RSV) vaccines. Disease enhancement has also been observed with the live tetravalent dengue vaccine, Dengvaxia.  

Vaccine induced disease enhancement occurs when the vaccine primes detrimental T cell response or antibodies in the recipient and increases the risk for infection or severe disease. This means that a vaccinated person may seem fine until they contract the illness, but the excess non-neutralizing antibodies not only fail to protect the person from infection but actually make it easier for the virus to infect cells and cause damage and, as a result, the disease is much more severe than it would have otherwise been.   

 

COVID-19 Vaccine Development Efforts

By mid-March and early April 2020, the WHO, National Institutes of Health  universities,  and global pharmaceutical corporations  had announced development of more than 50 experimental COVID-19 vaccines.   

Responding to the call by public health officials to lockdown the U.S. with in-home quarantines, Congress passed the CARES Act signed into law on March 27, 2020 that would cost American taxpayers over two trillion dollars. This federal legislation included $27 billion for development of COVID-19 vaccines, drug therapies and purchase of pandemic medical supplies. The legislation, however, did not include a cap placed on how much money drug companies could charge and profits they could make on the COVID-19 vaccines and drug therapies they develop with the use of money from the government. 

On March 30, 2020, the HHS Assistant Secretary of Preparedness and Response announced that the government was taking steps to “speed the development and manufacturing of vaccines to prevent COVID-19.”  

The Biomedical Advanced Research and Development Authority (BARDA) was created by Congress in 2006 under the Pandemic and All Hazards Preparedness Act,  legislation that has given billions of dollars to DHHS since then to develop “bioterrorism” and pandemic influenza vaccines.  That federal legislation also removed all civil liability from pharmaceutical companies for injuries and deaths caused by vaccines and drugs manufactured in response to declared public health emergencies, such as pandemics. 

Johnson & Johnson issued a press release on March 30, 2020, stating that BARDA had awarded Janssen Pharmaceutical Companies $1 billion to establish new U.S. vaccine manufacturing capabilities and additional production capacity outside the U.S to produce a global supply of more than 1 billion doses of the COVID-19 vaccine. 

According to a March 30, 2020 Reuters report, Moderna, Inc. “also signed a deal with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. The arrangements were part of the federal government’s effort to encourage drugmakers to be able to produce massive amounts of COVID-19 vaccines even before any are proven to work.” 

In May 2020, former President Donald Trump formally announced the framework and leadership of “Operation Warp Speed”, a private-public partnership aimed at making a COVID-19 vaccine available to the public by January of 2021. Trump appointed venture capitalist and former Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline Dr. Moncef Slaoui as chief advisor on vaccine development. General Gustave F. Perna, the U.S. army’s four-star general responsible for global supply chain and materiel and installation readiness for the U.S. Army, was selected as chief operating officer and charged with COVID-19 vaccine distribution. 

 

U.S. Food and Drug Administration Vaccine Approval process

On June 30, 2020, the U.S. Food and Drug Administration (FDA) announced that a COVID-19 vaccine would only receive approval if it were at least 50 percent more effective than a placebo at either preventing infection or reducing illness severity. 

The FDA released its guidance for industry regarding EUA approval for COVID-19 vaccines on October 6, 2020, and stated that they would be requiring that at least half of all Phase 3 clinical trial participants be followed for at least two months following administration of the second vaccine dose. The FDA also requested that vaccine makers submit information on a minimum of five cases of severe COVID-19 disease among individuals who received the placebo. 

Under EUA authority, the FDA Commissioner may permit “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.” 

On October 22, 2020, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss COVID-19 vaccine safety and efficacy, and included groups representing ethnic and racial minorities.  VRBPAC is comprised of non-FDA “experts” whose charge is to provide “advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.” 

Safety concerns dominated much of the meeting and several committee members expressed worry that the median two-month safety monitoring period appeared to be “arbitrary”. Additionally, if EUA approval was granted, there was concern that placebo control groups and blinding of the Phase 3 trials would be halted immediately and additional vital data would be lost. 

A presentation on vaccine hesitancy by the Reagan-Udall Foundation for the Food and Drug Administration, a nonprofit established by Congress to advance the FDA’s overall mission, reported on the public’s concern over the speed of vaccine development and their overall distrust of the healthcare system and of government. Several committee members stated that allowing a COVID-19 vaccine to be approved under EUA would only increase vaccine safety concerns. 

Concerns that minority populations were under-represented in clinical trials were discussed, however, Dr. Doran Fink of the FDA's Office of Vaccines Research and Review stated that while under-representation was not ideal, this would not cause the vaccine to be restricted for use in this demographic.  Vaccine hesitancy among racial and ethnic minorities was also highlighted and attributed to past historical experiments that have resulted in mistrust of government and health officials. 

COVID-19 vaccine efficacy discussions included a presentation by Dr. Hilary Marston, of the National Institutes of Health, who recommended that the FDA require at least a 60 percent efficacy rate for any approved COVID-19 vaccine. 

Several committee members expressed concern that the FDA had allowed vaccine manufacturers to use broad definitions of COVID-19 disease as their primary endpoint criteria. Concerns included the potential that a vaccine that showed protection against mild disease could be licensed even though the product did not reduce hospitalizations or deaths. 

VRBPAC Committee members also did not unanimously support the idea of allowing data from adult vaccine trials to be used to measure vaccine efficacy for children. VRBPAC Chair, Dr. Arnold Monto cautioned that due to differing immune responses and the potential risk of Multisystem Inflammatory Syndrome in Children (MIS-C), standard bridging of data may be inappropriate. 

Additional VRBPAC meetings for each vaccine candidate approval or EUA was promised by the FDA, however, the FDA would not be required to follow any of the recommendations made by their federal committee. 

 

Gene-Based Vaccines and Traditional Vaccines

Drug companies and government agencies racing to be the first to license a COVID-19 vaccine, began using different technology platforms to create experimental vaccines: inactivated virus, attenuated virus, recombinant protein subunit, virus-like particle, DNA, RNA and replicating and non-replicating viral vector.  Traditional viral vaccines contain attenuated or inactivated viruses or protein subunits in addition to adjuvants, such as aluminum, to stimulate an immune response that produces artificial immunity. For the past two decades, researchers have been experimenting with new technology platforms, notably ones that introduce foreign DNA and RNA directly into the body’s cells for the purpose of developing experimental vaccines for SARS, MERS, HIV and other diseases. 

Gene-based vaccines, which include DNA and mRNA types, encode for a specific viral protein from a pathogen - such as the spike protein for the SARS-CoV-2 virus. The genetic encoding instructs cells in the vaccine recipient to produce antigens that stimulate the immune system to produce antibodies specific to the antigen, without the recipient becoming infected by the pathogen that causes the disease. Compared to traditional vaccines, nucleic acid (genetic) vaccines are inexpensive and easier to manufacture because they consist only of DNA or RNA, which is taken up and translated into protein by host cells.   

 

COVID-19 mRNA Vaccine Development

Messenger RNA (mRNA) vaccines inject human cells with mRNA, usually within lipid nanoparticles, to stimulate cells in the body to become manufacturers of viral proteins.    In March 2020, a virologist at Imperial College London told Chemistry World that one advantage of using mRNA technology to make vaccines for humans is that, “Rather than generating proteins in a manufacturing plant and purifying them, you are getting the muscle to do the job and make the protein itself.” 

While traditional vaccines typically work with a person’s acquired immune system (immunity gained from exposure to pathogens), COVID-19 mRNA vaccines also have the potential to trigger an immune response from a person’s innate immune system, or the immunity we are born with. However, there are many unknowns, such as length of immunity provided by COVID-19 mRNA vaccines, whether or not the correct viral proteins have been chosen, and the frequency and severity of vaccine reactions and disease enhancement. 

 

Moderna COVID-19 Vaccine

The National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Anthony Fauci issued a press release on March 16, 2020 announcing that a Phase 1 human clinical trial conducted by Kaiser Permanente Washington Health Research Institute in Seattle had begun to evaluate an experimental mRNA vaccine for COVID-19 (mRNA-1273) co-developed by NIAID scientists and scientists at Moderna, Inc, based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness (CEPI) helped fund the manufacturing of the vaccine for the Phase 1 clinical trial. 

Moderna and NIAID began conducting human trials of the experimental mRNA-1273 COVID-19 vaccine prior to first conducting pre-clinical animal trials, which has been an important and customary part of vaccine development and testing process.  On March 30, 2020, Moderna stated that its COVID-19 vaccine might be ready for emergency use in certain individuals, including healthcare workers, by the fall of 2020. 

Although neither DNA or mRNA vaccines had been tested in large-scale clinical trials, an April 3, 2020 article in Chemical and Engineering News highlighted the breakneck speed at which COVID-19 vaccines “are moving new technologies from the computer and into the clinic at an unprecedented rate.” What should be separate pre-licensure phases for proving safety and effectiveness - preclinical animal models, clinical testing, and manufacturing – were now “happening all at once.” 

Moderna announced on May 18, 2020, that Phase 1 human clinical trials of its experimental COVID-19 vaccine showed positive results, with eight of the 45 healthy adult volunteer trial subjects developing antibodies that may provide protection against the SARS-CoV-2 virus. 

The company also reported that four participants suffered Grade 3 vaccine reactions. Of the four participants who experienced Grade 3 reactions, three had received the 250-µg dose level and one had received the 100-µg dose level. The U.S. Department of Health and Human Services (HHS) describes a Grade 3 adverse event as

“severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care” such as “bathing, dressing and undressing, feeding self, using the toilet, taking medications.” 

On July 27, 2020, National Institute of Allergy and Infectious Diseases (NIAID) announced that Phase 3 clinical trials of the Moderna COVID-19 vaccine had begun. The vaccine, a joint venture between Moderna, Inc., and the NIAID, part of the National Institutes of Health (NIH), was expected to enroll 30,000 healthy COVID-19-negative adults at 89 clinical test sites. 

According to NIAID, study participants would be randomly assigned 1:1 to receive either two doses of the 100- µg experimental mRNA COVID-19 vaccine or two normal saline placebo doses. NIAID officials reported that the study’s primary goal was to evaluate vaccine safety and whether two vaccine doses could prevent symptoms of COVID-19. Additional secondary goals included evaluation of the vaccine’s ability to prevent severe COVID-19 disease or death, and the effectiveness of a single vaccine dose in preventing symptomatic COVID-19. 

Moderna COVID-19 Vaccine EUA

In the U.S., Moderna’s mRNA COVID-19 vaccine Phase 3 clinical trials initially stalled due to the inability by company officials to recruit enough minority volunteers – a requirement of the FDA for any vaccine maker seeking Emergency Use Authorization (EUA) for its product. Health officials blamed past unethical and immoral medical experiments that targeted minority populations and not employing people of color to recruit minority clinical trial volunteers.  However, on October 22, 2020, Moderna reported that it had completed enrollment of trial participants and had recruited 11,000 participants from ethnically diverse communities  and participants between 18 and 65 years of age with underlying conditions. 

On November 16, 2020, Moderna announced that its experimental mRNA vaccine candidate showed a 94.5 percent efficacy against COVID-19. Company officials reported that their first interim results found a total of 95 COVID-19 cases among trial participants, with 90 cases in the placebo group and five in the vaccine group. According to Moderna, no severe cases of COVID-19 occurred among the vaccine recipients while 11 severe cases occurred in the placebo cases. 

There was insufficient data on the use of Moderna’s COVID-19 vaccine in persons who were positive for SARS-CoV-2 at baseline. In clinical trials, there were no cases of COVID-19 illness in persons who were determined to be positive for SARS-CoV-2 at baseline in the vaccine group, and only one case among the SARS-CoV-2 positive individuals at baseline who were part of the placebo group. 

Moderna’s Phase 3 clinical trials were not designed to determine whether their vaccine could reduce the impact of COVID-19 illness by decreasing hospitalizations, intensive care stays, or death. Additionally, Moderna did not study the vaccine to determine whether it could halt SARS-CoV-2 virus transmission. The durability of vaccine-acquired immunity was not known, and safety and efficacy data were limited in immunocompromised persons and in children and adolescents. 

On December 18, 2020, the FDA issued an EUA for Moderna’s mRNA COVID-19 Vaccine for use in persons 18 years of age and older. 

Within days of the EUA approval, cases of anaphylaxis following vaccination with Moderna’s COVID-19 vaccine began occurring. According to a report published by the CDC, between December 21, 2020 and January 10, 2021, 108 adverse events reports were identified as possible cases of severe allergic reaction to the vaccine. However, health officials considered only 10 cases to be anaphylaxis and reported that anaphylaxis occurred at a rate of 2.5 cases per million doses of Moderna COVID-19 vaccine administered. 

Deaths following Moderna’s COVID-19 vaccination were also reported. On Jan. 5, 2021, baseball Hall of Famer Hank Aaron was administered the Moderna vaccine in an event that appeared to encourage others, especially African-Americans, to receive the vaccine. Seventeen days later, on January 22, 2021, Aaron died. Health officials have denied that the COVID-19 vaccine played a role in his death, and reported that his death post-vaccine was purely coincidental. 

A study published in November 2021 in the New England Journal of Medicine that examined the Phase 3 clinical trials noted that there were 17 deaths in vaccine group and 16 deaths in the placebo group. Additionally, study authors reported that one COVID-19 related death occurred among Moderna vaccine recipients and three COVID-19 related deaths occurred among placebo recipients.   

Moderna mRNA COVID-19 Monovalent Booster Doses

In early April 2021, Moderna CEO Stéphane Bancel reported that a third vaccine dose would be needed within one year. In an interview with Business Insider, Bancel stated that "I hope this summer to get the vaccine authorized for a boost so that we can help people getting boosted before the fall, so that we all have a normal fall and not a fall and winter like we just saw in the last 6 months." Moderna officials reported that the vaccine was 90 percent effective six months after the second vaccine dose. 

On July 8, 2021, the CDC and FDA announced that booster doses of COVID-19 vaccines were not required but they, along with the National Institutes of Health (NIH), were actively engaged “in a science-based, rigorous process to consider whether or when a booster might be necessary.” 

According to a pre-peer review study conducted by researchers from the Mayo Clinic and nference, a data analytics company, by July 2021, the Moderna COVID-19 vaccine was reported to be only 76 percent effective. This study was conducted during a time when approximately 70 percent of the case were reported as being of the Delta variant. 

One month later, the FDA authorized use of a third dose of the Moderna COVID-19 vaccine in persons with immunosuppressive conditions.  These individuals were recommended to receive a three dose primary series of a 100mcg dose of the vaccine. 

On August 18, 2021, Health and Human Services (HHS) announced a plan to begin administration of COVID-19 mRNA booster doses beginning the week of September 20, 2021, with public health officials recommending the third dose be given eight months after second COVID-19 dose.  Leading health officials, however, reported that review of the application to support use of a third Moderna vaccine dose would likely not be completed prior to the White House’s September 20, 2021 timeline. According to health officials, data submitted by Moderna to the FDA as of September 1, 2021 was inadequate to support the recommendation. 

The FDA authorized a 50mcg booster dose, or half dose, of the Moderna COVID-19 vaccine on October 20, 2021, to be given six months following administration of the second vaccine dose.  One day later, the CDC approved use of the booster dose in all persons 65 years of age and older, in persons 18 and older at risk for severe COVID-19 disease, and in persons 18 and older who live or work in a setting that puts them at an increased risk of exposure to SARS-CoV-2. 

A first booster dose of mRNA COVID-19 vaccine was authorized by the FDA and recommended by the CDC for use in all persons 18 years and older who were previously vaccinated with two doses of an mRNA vaccine (Pfizer-BioNTech or Moderna) on November 19, 2021. The booster dose was initially recommended at least six months following receipt of the second mRNA COVID-19 vaccine dose.    On January 7, 2022, the interval between the second vaccine dose and the booster dose was shortened to five months. 

On March 29, 2022, a second booster dose was authorized by the FDA and recommended for all persons 50 years and older, to be given at least four months after the first booster dose. Immunocompromised individuals who received a 3- dose primary series and a single booster dose were also recommended to receive a second booster dose, at least four months after the initial booster dose.   

The FDA issued an EUA to Moderna in June 2022 for use of a 100mcg mRNA COVID-19 vaccine for use in adolescents aged 12 through 17 years. Additionally, the FDA also authorized use of a 50mcg mRNA COVID-19 vaccine dose in children 6 through 11 years of age and a 25mcg vaccine dose in infants and young children aged 6 months through 5 years.  One day later, the CDC recommended use of the Moderna vaccine in infants and young children.  On June 24, 2022, the CDC approved use of the vaccine in children and adolescents aged 6 through 17 years. 

According to the FDA, the efficacy of two 25 microgram doses (one quarter of the adult dose) of the Moderna COVID vaccine given about a month apart to children six months to five years old, who had not been previously infected with SARS-CoV-2, was 50.6 percent in preventing symptomatic COVID-19 in a six to 23-month-old age group and 36.8 percent effective in a two to five year old age group. The FDA also reported that two 50 mcg doses (one half of the adult dose) in children six through 11 years and two 100mcg doses in teenagers aged 12 through 17 years induced an immune response similar to adults who received the Moderna COVID-19 mRNA vaccine. 

On August 31, 2022, the FDA withdrew the EUA for the original monovalent booster dose for adults 18 and older when it authorized a single booster dose of a bivalent Moderna mRNA COVID-19 vaccine containing the original Wuhan strain and the Omicron variant BA.4/BA.5.  The FDA revoked the EUA for the Moderna monovalent booster dose for all persons six years of age and older on October 12, 2022 when it granted an EUA to Moderna for a bivalent mRNA COVID-19 vaccine in individuals six years and older. 

Moderna COVID-19 mRNA Vaccine Approval

On January 31, 2022, the FDA licensed and granted EUA status to Spikevax COVID-19 vaccine, an mRNA vaccine developed by Moderna, for use in persons 18 years of age and older. The FDA also stated that use of Spikevax and the experimental Moderna mRNA COVID-19 vaccine are interchangeable due to having the same formulation.  The CDC’s ACIP voted on February 4, 2022 to recommend the use of this vaccine for all persons 18 years and older. 

Spikevax received approval by the FDA based on the Phase 3 trial of vaccine efficacy data collected between July 27, 2020 and March 26, 2021, or when the participant decided that they no longer wanted to be blinded. On average, the median follow-up in the blinded placebo-controlled study was four months following dose two. The Phase 3 study involving 30,415 individuals 18 years and older, with half receiving 2 doses of the vaccine, and half receiving 2 doses of a saline placebo. 

According to the data provided by Moderna to the FDA to support approval for the Spikevax vaccine, there were 55 cases of COVID-19, with two cases classified as serious among the vaccine recipients and 744 cases of COVID-19 with 106 classified as serious in the placebo group during the blinded study period. The vaccine efficacy of Spikevax was reported to be 93.2 percent during this time period. 

There were, however, a total of 32 deaths reported during the blinded Phase 3 clinical trial, with 16 occurring among vaccine recipients and 16 among those who received the placebo. One COVID-19 death was reported among vaccine recipients and three COVID-19 deaths were reported in the placebo group. The remaining deaths that occurred during the clinical trial were reported as being unrelated to vaccination.  In the open-label phase of the trial, by May 4, 2021, there were 12 deaths reported. Eight deaths occurred among individuals who received the Moderna vaccine and three deaths occurred among persons who initially received the placebo but chose to receive the Moderna vaccine when offered. Only one death occurred in the placebo group. All deaths, however, were reported as being unrelated to vaccination by clinical trial investigators. 

The vaccine was not evaluated for its effectiveness against the Omicron variant, even though this variant was the predominant circulating strain at the time of FDA approval. 

Moderna COVID-19 Bivalent Booster Doses

On August 31, 2022, the FDA issued an EUA to Moderna for a bivalent mRNA COVID-19 vaccine to be given as a single dose in persons 18 years and older. This dose was recommended at least two months following receipt of the primary series or booster dose.  The FDA authorized use of the Moderna bivalent mRNA COVID-19 vaccine in all persons six years and older on October 12, 2022.  Bivalent booster doses were authorized despite a lack of clinical data in humans to support the safety or effectiveness of the product.   

In December 2022, the FDA authorized use of the Moderna bivalent mRNA COVID-19 for use in infants and children age six months through five years, to be administered at least two months after completion of the primary COVID-19 vaccine series or most recent booster dose. No clinical studies of this vaccine were conducted prior to the FDA authorization.  One day later, the CDC Director recommended use of the vaccine in this population without a recommendation or vote from ACIP. 

Discontinuation of Moderna Monovalent COVID-19 vaccines

On April 18, 2023, the FDA announced changes to the COVID-19 vaccination schedule to allow bivalent COVID-19 vaccines to be administered for all doses for individuals six months of age and older and that the monovalent COVID-19 vaccines would no longer be authorized for use in the U.S. The FDA reported that most individuals who had not yet received any COVID-19 vaccines could receive a single dose of COVID-19 bivalent vaccine instead of multiple doses of the monovalent vaccine. Children six months of age through five years were recommended to receive two doses of the Moderna bivalent COVID-19 vaccine. 

The FDA reported that their decision was based on the original clinical trial data to support use of the Moderna monovalent COVID-19 vaccine in individuals six months of age and older and from the results of an “investigational” bivalent COVID-19 vaccine (original strain and Omicron BA.1) in adults aged 18 years and older. Additionally, the FDA also reported that the decision also included a review of immune response data that demonstrated that 145 individuals aged six and older with a past history of COVID-19 illness who received a single dose of the Moderna Bivalent COVID-19 vaccine had comparable immune responses to 1,376 individuals aged six and older without a prior history of COVID-19 illness and who received 2 doses of the Moderna COVID-19 monovalent vaccine.  

The FDA also stated that the data collected from the Moderna monovalent COVID-19 vaccine and the investigational bivalent COVID-19 vaccine (original strain and Omicron BA.1) was relevant to Moderna’s Bivalent COVID-19 vaccine “because these vaccines are manufactured using the same process.”  

Moderna Vaccine Contamination Concerns

In late August 2021, Japanese health officials announced that it had suspended the use of 1.63 million Moderna mRNA vaccine doses after contaminants were noted in certain vials. These contaminants were reported to be stainless steel particles that were attributed to the manufacturing process. Company officials from Moderna along with representatives from Takeda Pharmaceuticals, the company that distributed the vaccine for use in Japan, reported that they did not believe that the stainless-steel contaminants would cause adverse health problems. Company officials reported that the particles were likely caused by friction between metal in the machinery used to place the stoppers on the vaccine vials. 

Three deaths following receipt of the contaminated vaccines have been reported by Japanese health officials as of September 2021. The deaths, however, were considered coincidental and unrelated to vaccination. 

On September 7, 2021, Japan stopped use of the Moderna vaccine and announced plans to begin use of the Novavax COVID-19 vaccine.  

In April 2022, Moderna recalled 764,900 vaccine doses in Europe after contaminants were found in a vial. The vaccine maker did not reveal what contaminants were found but reported that the recall was issued out of “an abundance of caution.” 

Profits from Moderna COVID-19 Vaccines

Sales of the Moderna COVID-19 vaccine were expected to earn the company approximately $19.2 B in 2021.  In 2022, Moderna reported $18.4B in sales from its COVID-19 vaccine and sales in 2023 are projected to reach $5B. 

 

Pfizer-BioNTech COVID-19 Vaccine

Another experimental mRNA COVID-19 vaccine developed in a partnership between U.S. based pharmaceutical giant Pfizer, and German drug maker BioNTech, began human trials in late April 2020 in Germany. In early May 2020, Phase 1 and Phase 2 clinical U.S. trials evaluated the safety, tolerability, immunogenicity and potential efficacy of four different SARS-CoV-2 mRNA vaccine candidates using a two-dose or single-dose schedule, at up to three different dose levels and in three age groups (18 to 55 years old, 65 to 85 years old and 18 to 85 years old). 

Trial participants were expected to receive one of four vaccine candidates—BNT162a1, BNT162b1, BNT162b2, BNT162c2 or a placebo. Each vaccine candidate represented a different mRNA formulation and target antigen. Albert Bourla, CEO of Pfizer, stated that if one or two variations of the vaccine candidates appeared successful, human trials would expand to include thousands of participants by September 2020 with plans to deliver millions of vaccine doses by October 2020.  

The Phase 1/2 trials involved 45 healthy adults between the ages of 18 and 55 years and over 50 percent of participants experienced adverse reactions. Two participants suffered severe reactions. A Grade 3 fever of over 101.3°F two days after vaccination was experienced by one adult and sleep disturbance one day after vaccination was experienced by another. 

On July 27, 2020, Pfizer and BioNTech announced the beginning of Phase 2/3 global trials (except China) of their BNT162b2 vaccine candidate. This experimental vaccine was a 30µg level dose administered in a 2-dose regimen. Company officials reported that trials would include up to 30,000 adults between 18 and 85 years of age and if successful, they would pursue regulatory approval of some form by October 2020. If approved, their plan was to supply up to 100 million doses globally by the end of 2020, and 1.3 billion doses by the end of 2021. 

In mid-September, Pfizer and BioNTech reported that they had submitted an amended plan to the FDA to increase the number of trial participants to 44,000 and permit inclusion of individuals with chronic and stable Hepatitis B, Hepatitis C, and HIV as well as adolescents as young as 16 years of age.  They also noted that trial participants were reporting mild-to-moderate adverse reactions which included headache, fatigue, chills, and muscle pain. Fevers, including high fevers, were also reported. Pfizer’s head of vaccine research and development stated that the data was being monitored by an independent monitoring committee that "has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date." 

Pfizer-BioNTech COVID-19 Vaccine EUA

On November 9, 2020, Pfizer-BioNTech issued a press release reporting that their experimental COVID-19 vaccine had an efficacy rate of over 90 percent “at 7 days after the second dose” in trial participants who had no prior history of SARS-CoV-2 infection.  It was, however, not yet known how long vaccine-acquired immunity from the Pfizer-BioNTech vaccine would persist. 

In data submitted to the FDA, Pfizer-BioNTech reported that 170 cases of laboratory confirmed SARS-CoV-2 infections had occurred in clinical trial participants, with eight reported in the vaccine group, and 162 in the placebo group. However, clinical data also reported a category of disease referred to as “suspected COVID-19” illness. This category involved persons who had symptoms of COVID-19 but were not laboratory confirmed. In the Pfizer study, 3,410 cases of suspected COVID-19 illness were reported, with 1,594 occurring in the vaccine group, and 1,816 in the placebo arm. 

In a published editorial, associate editor of the British Medical Journal (BMJ), Dr. Peter Doshi, questioned Pfizer-BioNTech’s efficacy data: 

“With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).”

(Footnote - Calculations in this article are as follows: 19% = 1 – (8+1594)/(162+1816); 29% = 1 – (8 + 1594 – 409)/(162 + 1816 – 287). I ignored denominators as they are similar between groups.) 

Doshi also noted that clinical trials were not designed to determine whether the COVID-19 vaccine could stop transmission of the SARS-CoV-2 virus, and that evaluation of the impact of the vaccine on the reduction of hospitalizations and deaths should be performed. Clinical trial data also revealed that eight people who previously tested positive for SARS-CoV-2 were found to have confirmed, symptomatic COVID-19 illness post-vaccination. This included one person in the vaccine arm, and seven in the placebo group. These results may indicate that COVID-19 vaccines might not prevent reinfection in previously infected individuals. In addition, Doshi stated that false negative PCR test results would significantly decrease the vaccine’s efficacy, and that “suspected” COVID-19 cases could be due to other viruses. 

There was also insufficient data to support the use of Pfizer-BioNTech’s COVID-19 vaccine in persons who were previously infected with SARS-CoV-2. In clinical trials, there was one case of COVID-19 illness in both the vaccine group and the placebo group in persons who were found to be positive for SARS-CoV-2 at baseline. Based on the limited data of this sub-population provided to the FDA by Pfizer-BioNTech, the vaccine efficacy in this population was reported at -7.1 percent (Confidence Ratio -8309.9, 98.6). 

Pfizer-BioNTech applied for Emergency Use Authorization (EUA) approval from the FDA on November 20, 2020  and received EUA approval on December 11, 2020 for use in persons 16 years of age and older.  While the FDA approved use of the experimental vaccine in 16 and 17-year-old individuals, in clinical trials, only 153 adolescents were enrolled, with 77 receiving the vaccine, and 76 receiving the placebo. 

The experimental vaccine was previously granted EUA status in the U.K. on December 2, 2020  and within days of the vaccine’s initial roll-out, reports of anaphylaxis following vaccination began to surface. This prompted U.K. health officials to issue a warning against administration of the vaccine in persons with a previous history of anaphylaxis to any medicine or food. 

Immediately following the FDA issuance of an EUA for Pfizer-BioNTech’s COVID-19 vaccines, reports of anaphylaxis began to appear in the U.S. media. Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, suggested that a chemical ingredient called polyethylene glycol (PEG)—a polymer derived from petroleum used as an excipient (a diluting agent) in both the BNT162b2 vaccine and Moderna’s COVID-19 vaccine known as mRNA-1273, was likely responsible for the severe reactions. 

Between December 14 and 23, 2020, 21 cases of anaphylaxis were reported to the federal Vaccine Adverse Events Reporting System (VAERS), with 71 percent occurring within 15 minutes of vaccine administration. Of these cases, 17 reports were in persons with a past history of allergic reaction, including seven who had previously reported a history of anaphylaxis. Public health officials reported that anaphylaxis following Pfizer-BioNTech’s COVID-19 vaccine occurred at a rate of 11.1 cases per million doses administered. 

In addition to reports of anaphylaxis, deaths following Pfizer-BioNTech’s vaccine administration were also reported to VAERS. In January 2021, a 56-year-old obstetrician developed a bleeding disorder within 72 hours of vaccination, and died 16 days later of a stroke. 

In January 2021, health officials in Norway reported that they were investigating the deaths of 23 elderly individuals following vaccination with the Pfizer-BioNTech COVID-19 vaccine. The Norwegian Medicines Agency (NOMA) concluded that in 13 of the 23 deaths, common mRNA vaccine adverse reactions, such as diarrhea, fever, and nausea may have contributed to the deaths in the frail patients.  Deaths following the Pfizer-BioNTech COVID-19 vaccine were also reported in Israel,  Germany,  Portugal and Switzerland. 

A study published in November 2021 in the New England Journal of Medicine on the Phase 3 clinical trials of the Pfizer-BioNTech COVID-19 vaccine reported 15 deaths among vaccine recipients and 14 deaths among those who received the placebo. One death in the vaccine group and two deaths in the placebo group were reported to be related to COVID-19. Non-COVID-19 related deaths in the vaccine group included cardiac arrest, sepsis, septic shock, arteriosclerosis, cardiopulmonary arrest, congestive heart failure, chronic obstructive pulmonary disease, lung cancer, and hypertensive heart disease.   

In mid-December 2020, pharmacists administering the Pfizer-BioNTech COVID-19 vaccine discovered that vials contained six or even seven vaccine doses, instead of five – the amount listed on the product vial. The extra doses were attributed to overfill of the vials and dependent on the type of needle and syringe used to administer the vaccines.  In January 2021, the FDA officially granted Pfizer’s request to update the EUA Fact Sheet to clarify that each vial contained six doses. 

In order for all six vaccine doses to be extracted from the vial, special syringes known as low dead space syringes were required, which were in short supply. The lack of proper syringes caused controversy in Europe in January 2021 when it was revealed that Pfizer would be paid for six vaccine doses of the vaccine even though it would only be possible to extract five doses from the vial. The U.S. government finalized a contract with Pfizer that would permit government officials to track which vaccine shipments came with dead space syringes and which did not. Shipments accompanied by dead space syringes would be counted as having six doses per vial, while those with regular syringes would count as having only five. 

In the spring of 2021, Pfizer-BioNTech began testing their product for use in children 12 to 15 years of age.  On April 9, 2021, company officials announced that they had submitted a request to the FDA for approval of the vaccine for use in this population. 

On May 10, 2021, the FDA expanded the EUA granted to Pfizer/BioNTech for use of its experimental mRNA vaccine in children as young as 12 years old  and the CDC’s ACIP voted to approve its use in this population on May 12, 2021. 

The approval for use in adolescents 12 to 15 years was based on a small clinical trial involving 2,260 teens, of which 1,131 received the vaccine and 1,129 received a saline placebo.  According to data provided by the vaccine manufacturer, the vaccine was reported to be 100 percent effective at preventing COVID-19. In the clinical trial, there were no cases of COVID-19 in the vaccine arm and 18 cases in the placebo arm. There were no cases of severe COVID-19 illness or death reported among clinical trial participants. 

Clinical trial data reported the most common adverse events among 12 through 15 year olds to be injection site pain, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling and redness, lymph node swelling, and nausea. 

During the clinical trial, nearly 11 percent of 12- to 15-year-olds experienced a severe or Grade 3 vaccine reaction, with one study participant experiencing a Grade 4 reaction of a fever of 40.4°C. Five adolescents who received the Pfizer vaccine experienced a serious adverse event (SAE) during the trial, however, none of these events were considered by clinical trial investigators to be related to vaccination. 

On July 16, 2021, the FDA announced that it had accepted the Biologics License Application (BLA) from Pfizer requesting full licensure and had granted a priority review of the application.   In early August 2021, the FDA announced that it was aiming to fully approve the Pfizer-BioNTech COVID-19 vaccine by Labor Day. 

Pfizer-BioNTech COVID-19 Vaccine Approval

On August 23, 2021 the FDA licensed and granted EUA status to Comirnaty COVID-19 vaccine, an mRNA vaccine developed BioNTech, for use in persons 16 years of age and older.  The FDA also stated that use of Comirnaty and the experimental Pfizer-BioNTech mRNA COVID-19 vaccine were interchangeable due to having the same formulation.   The FDA, however, also stated that the Pfizer-BioNTech experimental vaccine and the BLA approved Comirnaty were legally distinct, but did not disclose how and why the two vaccines were legally distinct.    

Following FDA approval, the CDC’s ACIP recommended use of the 2-dose vaccine series in persons 16 years of age and older. 

When a product receives a priority review designation by the FDA, the decision to take action on the application is usually done within 6 months.  In the case of the Pfizer – BioNTech vaccine, the decision to grant full approval was completed in less than four months. 

Prior to granting approval of Comirnaty, the FDA declined to hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting  despite previously stating that they were committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”  In the Summary Basis for Regulatory Action Document published to support approval of Comirnaty, the FDA reported that it “did not refer this application to the VRBPAC because our review of the information submitted to this BLA did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.” 

In June 2021, a group comprised of international scientists, clinicians, and patient advocate organizations formally submitted a Citizen Petition with the FDA and requested that the regulatory agency delay full approval of COVID-19 vaccines. In their petition, the Coalition Advocating for Adequately Licensed Medicines (CAALM) appealed to the agency to slow down the approval process to ensure that the scientific data was thoroughly assessed. In their petition, the group detailed safety and efficacy criteria that the FDA needed to provide prior to full licensure. These included: 

  • Completion of a minimum follow-up for at least two years of individuals who participated in the clinical trials, including trials that are no longer placebo controlled;
  • Ensuring that evidence is clear that the benefits of vaccination outweigh the risks in specific populations such as in persons with previous SARS-CoV-2 infection, pregnant women, nursing women, infants, children, adolescents as well as in older adults, persons with immunosuppressive disorders, blood disorders, and those with cancer;
  • Requiring a complete safety review of the spike proteins being produced by the body after vaccination, as well as the spike proteins’ full distribution within the body, the pharmacokinetics, and tissue specific toxicity;
  • Completion of vaccine distribution studies at the injection site and the impact of the mRNA technologies in the tissues of the body;
  • A complete assessment and review of all severe adverse events and deaths reported to VAERS and other global vaccine safety monitoring systems following COVID-19 vaccination;
  • Full assessment of the safety of the vaccine in persons receiving more than two vaccine doses;
  • Include experts in gene therapy and delivery in VRBPAC meetings due to the significant differences between gene-based vaccines and traditional vaccines;
  • Ensure that individuals involved in reviewing clinical data submitted to support full approval are free of conflicts of interest with vaccine makers.

The FDA, however, disregarded the request made by the petitioners, and granted full approval of the Pfizer-BioNTech mRNA COVID-19 vaccine in persons 16 years of age and older without addressing the concerns expressed by CAALM.  

On August 23, 2021, Dr. Peter Doshi, Senior Editor of the British Medical Journal (BMJ), expressed concerns regarding the FDA approval in a reference article published in the BMJ Opinion. In his article, Doshi noted that approval of the vaccine was based on a data cut-off date of March 13, 2021, and did not adequately address the concerns of waning vaccine immunity or the efficacy of the vaccine against the Delta variant, which was circulating during this time. 

Doshi noted that the Pfizer data showed that from two months to just less than four months following vaccination, observed vaccine efficacy (VE) had decreased from 96 percent to 90 percent and further decreased to 84 percent from four months to the end date of the data cut off (March 13, 2021). He also noted that the Delta variant likely had little impact on decreased VE as most of the data was collected in the U.S. (77 percent of trial participants were U.S. residents) where Delta was not yet circulating.  

Data from Israel, which nearly exclusively administered the Pfizer-BioNTech COVID-19 vaccine, reported a VE of only 64 percent in early July 2021.   By late July 2021, the VE had dropped to 39 percent.  

Additionally, data submitted to the FDA on efficacy involved only seven percent of clinical trial participants who remained blinded up to six months post receipt of the second vaccine dose. By the March 13, 2021 cut off, 93 percent of clinical trial participants had received the vaccine because company officials had begun offering the placebo group vaccination beginning in December of 2020. Doshi noted that no data was submitted to the FDA on VE past 6 months following vaccination, which was the time frame that the Israeli data had reported the vaccine to have a VE of only 39 percent. 

Many in the medical community have stated that the clinical trials demonstrated the vaccine to be effective against severe COVID-19 illness and would reduce the number of hospitalizations and deaths. Doshi, however, noted that the clinical trials were not designed to study severe disease, that company officials did not report the number of hospitalizations, and that there were no COVID-19 related deaths. In this study, there was one reported case of severe COVID-19 disease in the vaccine group and 30 in the placebo group, but the study did not indicate the number of COVID-19 hospitalizations. There was also a total of three COVID-19 related deaths, one in the vaccine group and two in the placebo group.  

Following FDA approval, ACIP voted to recommend the 2-dose vaccine series for use in all persons 16 years of age and older.  In July 2022, the FDA licensed Comirnaty for use in persons 12 years of age and older. 

Full data that the FDA relied upon to license the Pfizer-BioNTech COVID-19 vaccine is currently under review by independent scientists. The non-profit Public Health and Medical Professional for Transparency, a group comprised of medical and public health professionals, journalists, and scientists, filed suit to have the full data released within 108 days, by March 3, 2022, which was the same time frame that the FDA took to fully license the vaccine. The FDA, however, proposed a plan to release the data on a rolling basis, providing 500 pages per month.  

In early January 2022, a court ordered the FDA to release 55,000 pages of data each month. 

Pfizer-BioNTech mRNA COVID-19 Vaccine in Children

On October 29, 2021, the FDA authorized the use of a 10mcg dose of Pfizer-BioNTech COVID-19 mRNA vaccine in children 5 through 11 years of age. The vaccine was authorized to be administered intramuscularly as a two-dose series, three weeks apart.  The CDC’s ACIP voted to approve use of the vaccine in all children 5 through 11 years on November 2, 2021. 

The authorization of the Pfizer-BioNTech vaccine in children 5 through 11 years was based on two cohort studies involving 3,100 children who received the vaccine, and 1,538 children who received a placebo. Only 1,444 vaccine recipients, those involved in the cohort 1 study, were monitored for safety and effectiveness for at least two months after the second vaccine dose. Data from children enrolled in the cohort 2 study was limited to only 2.4 weeks following the second vaccine dose. 

The FDA reported that the Pfizer-BioNTech 10-mcg vaccine was 90.7 percent effective at preventing infection. In clinical trials, three children who received the vaccine and 16 children who received the placebo developed COVID-19. No severe cases or deaths occurred among any children who developed COVID-19 infection. The FDA also reported that the immune responses to the 10-mcg vaccine in children 5 through 11 years were comparable to those from individuals 16 through 25 years who received the 30-mcg vaccine dose. 

A pre-print study pending peer review on the effectiveness of the Pfizer-BioNTech vaccine in children 5 – 11 years completed in New York State in December 2021 and January 2022 reported a decline in vaccine effectiveness from 65 percent to 12 percent by 28-34 days. 

Pfizer-BioNTech mRNA COVID-19 Vaccine in Infants and Young Children

The FDA issued an EUA to Pfizer-BioNTech for a 3mcg mRNA COVID-19 vaccine for use in infants and young children aged 6 months through 4 years on June 17, 2022.  The vaccine, which was authorized as a three-dose series, with a three week interval between the first and second dose, and a two month interval between the second and third dose.   Although Pfizer reported 80 percent efficacy after the third dose in children under five, the numbers of children evaluated were so tiny that the FDA staff simply commented in its June 15 briefing paper for VRBPAC that, “In these FDA analyses, the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants.” 

One day later, the vaccine was recommended for use in this population by the CDC, and the recommendation included use of the vaccine in infants and young children with a history of prior COVID-19 infection.  Authorization of the vaccine was made despite a lack of evidence to show that the vaccine was capable of stopping infection or transmission of the SARS-CoV-2 virus. 

Pfizer-BioNTech Monovalent mRNA COVID-19 Booster doses

On February 25, 2021, Pfizer-BioNTech company officials announced that they had begun evaluating the safety and effectiveness of a third dose of COVID-19 vaccine. The study was aimed at learning more on the effects of a booster dose for currently circulating and newly emerging SARS-CoV-2 variants. Specifically, Phase 1 clinical trial participants would be offered a 30µg booster dose of the current vaccine six to 12 months after completing the two-dose vaccine series. 

Additionally, Pfizer-BioNTech reported that they were in discussions with the FDA and the European Medicines Agency regarding plans for a clinical study of variant specific vaccine, including a vaccine targeting the South African B.1.351 (Beta) variant. 

In early March 2021, a small exploratory study out of New York University’s Grossman School of Medicine found that persons already recovered from SARS-CoV-2 virus infection receiving one dose of the vaccine produced more neutralizing antibodies to defend against future SARS-CoV-2 infection in comparison to persons who have not been infected with the SARS-CoV-2 virus and who had received two doses of the vaccine. 

In the spring of 2021, Pfizer CEO Albert Bourla reported that a third vaccine dose would likely be needed within 12 months, and annual shots might also be necessary.  Pfizer also reported that studies had shown the vaccine to be 93.1 percent effective six months after the second dose was administered. 

In late June 2021, Israeli health officials reported the Pfizer-BioNTech COVID-19 vaccine to be 64 percent effective against the SARS-CoV-2 variant B.1.617 (Delta).  By late July 2021, the vaccine’s effectiveness against the Delta variant in Israel had decreased to only 39 percent. 

The FDA and CDC announced in July 2021 that they were not recommending booster doses, but reported that they were monitoring data. The federal agencies also stated that they “are prepared for booster doses if and when the science demonstrates that they are needed.”  One month later, however, the FDA authorized use of a third dose of the Pfizer-BioNTech COVID-19 vaccine in immunocompromised individuals. 

Pfizer-BioNTech announced on August 16, 2021 that it had submitted data to the FDA to support the use of a COVID-19 booster dose. According to the press release issued by Pfizer, administration of a third COVID-19 vaccine dose produced higher levels of neutralizing antibody titers against the original SARS-CoV-2 virus as well as the Beta and Delta variants, in comparison to levels elicited following receipt of the 2-dose series. Company officials also reported that administration of a booster dose produced neutralizing antibody titers for variants that were equivalent to the wild type. 

On August 18, 2021, Health and Human Services (HHS) announced a plan to begin administration of COVID-19 mRNA booster doses beginning the week of September 20, 2021. Public health officials stated that they would be recommending that the third dose be administered eight months after receipt of the second COVID-19 booster dose. 

Not all public health officials agreed with the booster dose recommendation. Following the White House’s announcement on booster doses, two senior FDA vaccine officials announced their resignations. Their decision to leave the agency was reported to be related to the White House’s announcement on booster doses ahead of the FDA’s completion of review on the data to support this recommendation. 

On September 13, 2021, the Lancet published a report authored by 18 scientists, including several from the World Health Organization and the FDA, against a broad recommendation of mRNA booster doses in the general population. The authors expressed concerns that the introduction of booster doses too soon or too frequently could result in serious immune-related adverse events and may deter acceptance of the use of COVID-19 and other vaccines. While the authors reported that certain populations, such as those with immunosuppressive conditions, may benefit from a booster dose, they indicated that ensuring a primary vaccine series in previously unvaccinated individuals would save more lives than boosting previously vaccinated populations. 

On September 17, 2021, the FDA’s VRBPAC voted to authorize use of a third booster dose of the Pfizer-BioNTech mRNA COVID-19 vaccine under EUA in persons 65 years of age and older as well as those who were at high risk of severe illness. The booster dose for this population was recommended to be given six months following administration of the second dose. 

The FDA amended the Pfizer-BioNTech EUA on September 22, 2021 and authorized a booster dose in all persons 65 years and older, in individuals 50 through 64 years at high risk for COVID-19, and in persons 18 through 64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.” 

While the CDC’s ACIP voted on September 23, 2021 to recommend booster doses in all persons 65 and older, in persons 50 through 64 years with pre-existing health conditions that put them at increased risk from COVID-19 infection, and in persons 18 through 49 who were at risk of infection due to pre-existing health conditions if the individual believes that they need one, they voted against recommending a booster dose for all persons 18 through 64 years whose living or employment situation placed them at high risk for COVID-19 infection. CDC Director Dr. Rochelle Walensky, however, overruled ACIP and issued a recommendation for a booster dose of Pfizer-BioNTech COVID-19 vaccine in all persons 18 and older who work or live in high-risk settings. 

A Pfizer funded study published in the Lancet on October 4, 2021 reported that after six months, the vaccine was only 47 percent effective at preventing infection. Study authors, however, reported the vaccine to be 93 percent effective against COVID-19 hospitalization. The declining effectiveness of the vaccine was blamed on vaccine waning rather than on the variants. 

A study published in the New England Journal of Medicine in late October 2021 found that vaccine immunity waned within months of receipt of the second vaccine dose among all age groups. This study was based on data collected in an Israeli database between July 11 and July 31, 2021, for all Israeli residents who were vaccinated prior to June 2021. 

A retrospective study out of Sweden published in October 2021 found that the Pfizer-BioNTech vaccine progressively waned from a high of 92 percent effectiveness at 15 to 30 days post vaccination with the second vaccine dose, to 47 percent between day 121 and day 180. After day 211, no effectiveness from the vaccine could be detected. 

A booster dose of mRNA COVID-19 vaccine was authorized by the FDA and recommended by the CDC’s ACIP for use in all persons 18 years and older who were previously vaccinated with two doses of an mRNA vaccine (Pfizer-BioNTech or Moderna) on November 19, 2021, to be given at least six months following receipt of the second mRNA COVID-19 vaccine dose.    In early January 2022, public health officials shortened the interval of the booster dose recommendation to five months.  A fourth vaccine dose was also authorized in immunocompromised populations, to be administered at least three months following administration of a third dose. 

On December 9, 2021, the FDA authorized a booster dose of Pfizer-BioNTech vaccine for 16- and 17-year-olds. The authorization in this population was based on data examining the immune responses of 200 individuals between the ages of 18 and 55 years who received a third Pfizer-BioNTech mRNA vaccine about 6 months following their second dose. According to the FDA, the immune response of the third dose was compared to the immune response examined one month following the second dose in the same individuals, and the results showed a boost in antibody levels. 

The FDA also reported that the data they reviewed indicated a lower risk of myocarditis following the third vaccine dose when compared to the second dose.    A risk-benefit assessment completed by Pfizer-BioNTech was also reviewed by the FDA and was reported to support the booster dose recommendation in this population.  That day, the booster dose was recommended for use by CDC Director Rochelle Walensky, without a review of the data by ACIP to support use of the additional dose in this population.  In early January 2022, public health officials shortened the interval of the booster dose recommendation in 16 and 17- year olds to five months. 

A booster dose of Pfizer-BioNTech COVID-19 vaccine was authorized for use in 12 through 15-year-olds in early January 2022 by the FDA and CDC, to be administered five months following the second vaccine dose.   

In March 2022, the FDA and CDC authorized a second booster dose for persons 50 years of age and older, to be given at least four months following receipt of the first booster dose. Immunocompromised individuals were recommended to receive a 3-dose primary series of mRNA vaccine, followed by a booster dose at least three months after the third vaccine dose. A second booster dose could also be given at least four months after the first booster dose.   

The FDA and CDC authorized and recommended a booster dose for all children 5 through 11 years in May 2022, to be given at least 5 months after the second dose.  The FDA reported that the EUA for the booster dose was based on data that demonstrated an increase of antibodies post-vaccination in 67 children aged 5 through 11 years who received a booster dose seven to nine months after completion of the two-dose primary series.  

Pfizer-BioNTech mRNA COVID-19 Bivalent Booster Doses

Since the fall of 2020, multiple variants of the SARS-CoV-2 virus have emerged.  U.S. public health officials reported that while the current COVID-19 vaccines appeared to be effective against the variants,   they were in the process of developing guidance to help vaccine manufacturers adapt their products as needed.  

In June 2022, the FDA’s VRBPAC meet to discuss the “future framework” plan for COVID-19 vaccines. This plan, considered similar to the current flu vaccine strategy, would allow for all future reformulations of the COVID-19 vaccine to bypass any additional clinical trials due to their similarity to current vaccines.  The committee voted in favor of adding the Omicron BA.4/5 spike protein to the current vaccine to create a booster dose for use by early to mid-fall 2022. 

One of the committee members who voted against the booster dose reformulation, Dr. Paul Offit, expressed concern over a lack of data to support the recommendation. In an interview, Offit noted:

“There are potentially billions of dollars at stake to transform a vaccine from the ancestral strain to a new bivalent strain including these Omicron-specific boosters, without clear and compelling evidence that it’s actually going to improve the outcome we care about most which is protection against severe disease.”  

On August 31, 2022, the FDA issued an EUA to Pfizer-BioNTech for a bivalent mRNA COVID-19 vaccine to be given as a single dose in persons 12 years and older. This dose was recommended to be given at least two months following receipt of the primary series or booster dose. The FDA also withdrew the EUA for the original monovalent booster dose for persons 12 and older when it authorized a single booster dose of a bivalent Pfizer-BioNTech mRNA COVID-19 vaccine containing the original Wuhan strain and the Omicron variant BA.4/BA.5.  The FDA withdrew the EUA for the Pfizer-BioNTech monovalent booster dose for all persons five years of age and older on October 12, 2022 when it granted an EUA for the bivalent mRNA COVID-19 vaccine in individuals six years and older. 

No human trials of the bivalent mRNA COVID-19 vaccine were completed prior to the FDA issuing the EUA. Instead, the FDA authorized use of the vaccine based on data that showed a boost in immune responses against all Omicron variants in mice. The FDA also reported that the authorization was also based on data provided by the manufacturers on a bivalent COVID-19 vaccine containing the original strain and the Omicron BA.1 strain.   

In December 2022, the FDA authorized use of the bivalent vaccine for use in infants and children six months through four years of age, to be given as a single dose at least two months following completion of the 3-dose primary series. It was also authorized to be given as the third dose of the 3-dose primary series, following two doses of the monovalent COVID-19 vaccine, in infants and children who had not yet received a COVID-19 vaccine.  One day later, the CDC Director recommended use of the vaccine in this population without a recommendation or vote by ACIP. 

Discontinuation of Pfizer-BioNTech Monovalent COVID-19 vaccines

On April 18, 2023, the FDA announced changes to the COVID-19 vaccination schedule to allow bivalent COVID-19 vaccines to be administered for all doses for individuals six months of age and older and that the monovalent COVID-19 vaccines were no longer authorized for use in the U.S. The FDA reported that most individuals who had not yet received any COVID-19 vaccines could receive a single dose of COVID-19 bivalent vaccine instead of multiple doses of the monovalent vaccine. Children six months of age through four years were recommended to receive three doses of the Pfizer-BioNTech bivalent COVID-19 vaccine, while children aged five years were only recommended a single dose of the Pfizer-BioNTech bivalent COVID-19 vaccine. 

The FDA reported that their decision was based on the original clinical trial data to support use of the Pfizer-BioNTech monovalent COVID-19 vaccine in individuals six months of age and older, from the results of an “investigational” bivalent COVID-19 vaccine (original strain and Omicron BA.1) in adults aged 55 years and older, from safety data on the Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.4/BA.5) in persons 6 months of age and older and from immune response data in infants and children aged 6 months through 4 years of age.   The FDA also reported that use of a single dose of the Pfizer-BioNTech COVID-19 bivalent vaccine was also supported by observational data from England on the effectiveness of a single dose of the Pfizer-BioNTech monovalent vaccine. According to the FDA, 12- to 17-year-olds with a prior history of infection from the Alpha, Delta, or Omicron variant who received a single dose of the Pfizer-BioNTech monovalent COVID-19 vaccine had “increased protection” from symptomatic COVID-19 infection than those without a prior infection history. 

Again, the FDA reported that the clinical data pertaining to the Pfizer-BioNTech monovalent COVID-19 vaccine and the investigational Pfizer-BioNTech COVID-19 bivalent vaccine (original and Omicron BA.1) were relevant to the Pfizer-BioNTech COVID-19 bivalent vaccine “because these vaccines are manufactured using the same process.”  

Pfizer-BioNTech mRNA COVID-19 Vaccine Profits

Pfizer’s COVID-19 vaccines generated $36.8B in sales in 2021, and $37.8B in 2022. The company reported earnings of $100.3B in 2022, but announced it was expecting a 64 percent decrease in profits in 2023. This decrease was anticipated despite plans to increase the price of each dose of its Comirnaty vaccine to between $110 and $130 dollars. Earnings from the Pfizer COVID-19 vaccine in 2023 are expected to be at $14.4B. 

Pfizer-BioNTech mRNA COVID-19 Vaccine Contamination Concerns

In early September 2021, Japanese health officials reported that “floating matter” had been found in five unused vials of COVID-19 vaccines belonging to the same vaccine lot. Vaccines from the same lot continued to be administered after being visually inspected. Pfizer company officials responded by stating that the material was probably undissolved vaccine ingredients and would not impact the safety or efficacy of the product. Additionally, Pfizer also reported that by early September 2021, floating matter had been reported in at least 95 vials. 

Pfizer-BioNTech mRNA COVID-19 Vaccine Clinical Trial Data Integrity Issues

On November 2, 2021, the British Medical Journal published an investigational report on concerns related to the Phase 3 clinical trials of the Pfizer-BioNTech. From information provided by a whistleblower involved in the clinical trials, many concerning practices occurred at one of the Pfizer-BioNTech trial sites. Concerns included:

  • Clinical trial participants were not adequately monitored by staff post-vaccination
  • Protocol deviations were not reported
  • Improper vaccine storage
  • Lack of timely follow-up of individuals who experienced adverse reactions
  • Mislabeling of laboratory specimens
  • Targeting of staff who reported concerns

Brook Jackson, the whistleblower who reported concerns directly to the FDA, was reportedly terminated by the research company contracted to conduct the clinical trials. Despite receiving a complaint from Jackson regarding concerns associated with the clinical trial, the FDA failed to conduct a follow-up investigation. Two additional individuals employed with Ventavia, the same research company contracted with conducting the trials, have reportedly collaborated Jackson’s account of the situation. 

 

Heart Inflammation following mRNA vaccination

In May 2021, Israeli health officials reported a possible link between the Pfizer COVID-19 vaccine and myocarditis after reporting that 62 cases had been reported following vaccination. Of these cases, 56 had occurred following the second shot, and most had involved persons 30 years of age and younger. A Pfizer spokesperson, however, stated that a causal link had not been established and that they had not observed a higher rate of myocarditis post-vaccination than what would have been expected in the overall population. 

On May 17, 2021, the ACIP’s COVID-19 Vaccine Safety Technical (VaST) Work Group met and reviewed information on myocarditis following mRNA vaccines. VaST reported that most of the cases had occurred in teens and young adults, and more cases had occurred in males. Additionally, there were more cases reported after the second vaccine dose, and most occurred on average within four days of vaccination. Members of VaST reported that few cases had been reported but that information on myocarditis following COVID-19 vaccination should be given to vaccine providers. 

Reports of myocarditis and pericarditis following mRNA vaccines continued to increase and on June 11, 2021, the CDC scheduled an emergency ACIP meeting for June 18, 2021 to discuss the higher-than-expected number of cases. A total of 301 cases following Moderna vaccination and 488 cases following Pfizer vaccination had been reported at the time the meeting was scheduled. 

The meeting, however, was postponed due to the newly created Juneteenth National Independence Day holiday, with the CDC announcing that it would discuss concerns the following week at the regularly scheduled June ACIP meeting.  By the June 23, 2021 meeting, CDC officials reported that through June 11, 2021, 1,226 cases of myocarditis/pericarditis had been reported to VAERS, with 791 occurring after Pfizer vaccination and 435 after Moderna vaccination. Most cases had been reported in males, and most had occurred following the second dose. 

In the data presented during the June 23, 2021 ACIP meeting, the CDC reported that in females between the age of 12 and 17 years, after the second dose, the case rate of myocarditis/ pericarditis was 9.1 per million doses administered. In males 12 to 17 years of age, however, the reported rate after the second vaccine dose was 66.7 per million doses. Cases among females 18 to 24 years old after dose two were reported at 5.5 per million, while after dose two, males of the same age range were affected at a rate of 56.3 per million doses. Most cases of myocarditis/pericarditis resulted in hospitalization, and while most were reported as being resolved, the long-term health outcomes were reported to be unknown.   

The CDC, however, declined to pause use or make changes to the vaccine recommendations, as they reported the benefits to vaccination outweighed the risk. Additionally, they stated that persons with a history of myocarditis and pericarditis could still receive an mRNA vaccine and persons who developed pericarditis after the first mRNA vaccine dose could receive the second dose after symptoms resolved. The CDC also advised that individuals who developed myocarditis after the first dose could consider receiving a second dose under certain circumstances. No data to support this recommendation was provided. 

A study of myocarditis after mRNA vaccines on members of the military found a higher-than-expected number of cases following vaccination.  Additional studies have also associated mRNA vaccines with heart inflammation, with researchers reporting the need for further investigation.     

A population-based cohort study published in the British Medical Journal in December 2021 found that the Moderna COVID-19 vaccine was four times more likely to cause heart inflammation than the Pfizer vaccine.  A study published in Nature Medicine in December 2021 reported that men under the age of 40 were more likely to develop myocarditis following Moderna vaccination than following SARS-CoV-2 infection. 

In late February 2022, the CDC stated that the interval time between the first and second dose of mRNA vaccine could be extended to eight weeks. The increase in interval time was based on data suggesting that an increase in interval time might decrease the risk of heart inflammation, especially among males 12 through 39 years.   

 

Dosing Schedules for mRNA COVID-19 vaccines

When the mRNA COVID-19 vaccines were initially authorized, they were recommended to be given intramuscularly (IM) in a two-dose series. Doses of the Pfizer-BioNTech vaccine were recommended to be administered 21 days apart, while doses of the Moderna vaccine were to be given 28 days apart. In early January 2021, following reports in the media of alternative vaccine schedules which included giving a single vaccine dose, giving half doses, and using vaccine brands interchangeably, the FDA issued a press release to emphasize the need for clinicians to follow the authorized EUA dosing schedules. Agency officials reported that without clinical data to support alternative dosing schedules, the public could be put at risk and this might ultimately undermine efforts to protect people against COVID-19. 

In contrast, U.K. health officials announced in early January 2021 that it was prioritizing first dose administration to as many people as possible, and delaying the booster dose until more vaccines became available.   

Studies on the use of different combinations of COVID-19 vaccines were initiated by the University of Oxford and included the evaluation of the safety and effectiveness of using a different COVID-19 vaccine as the second vaccine dose. Vaccines involved in the clinical trials included Pfizer-BioNTech, Moderna, AstraZeneca, and Novavax. 

According to a study published in The Lancet on May 12, 2021, adults 50 years and older who received a mixed dose combination of the Pfizer-BioNTech vaccine and the AstraZeneca COVID-19 vaccine experienced more mild and moderate side effects than those administered only one type of vaccine. Systemic reactions, especially fever, were significantly higher after the second vaccine dose in persons who received the AstraZeneca vaccine followed by a dose of the Pfizer-BioNTech vaccine when compared to persons who received two doses of the Pfizer-BioNTech vaccine. There were also more reports of joint and muscle pain, chills, malaise, fatigue, and headache after the second vaccine dose in person who received a mixed dose schedule. 

On October 20, 2021, the FDA authorized use of a “mix and match” booster dose for all available COVID-19 vaccines. According to the FDA, the known and potential benefits of a single boost of a different vaccine outweighed the known and potential risks.   At the time of this recommendation, there was limited safety and effectiveness data to support the mixed-use vaccine schedule. 

 

Janssen/Johnson & Johnson COVID-19 Vaccine

In March 2020, Janssen/Johnson & Johnson announced that it had expanded its partnership with BARDA to reach its goal of providing one billion COVID-19 vaccine doses. Company officials reported that human trials of an experimental COVID-19 vaccine utilizing its AdVac® and PER.C6® technologies would likely begin in September 2020.  The AdVac technology uses an adaptation of human Adenovirus 26 to transport the genetic code of the SARS-CoV-2 spike protein into the body to trigger an immune response.    PER.C6 are proprietary cells owned by Janssen Pharmaceutical that were developed in 1985 from retinal cells of an 18-week-old aborted fetus. 

The Janssen/Johnson & Johnson experimental COVID-19 vaccine entered Phase 2 trials in Spain in mid-September 2020.  Clinical trials, however, were halted on October 12, 2020 after a participant developed an “unexplained illness.”  Sources familiar with the event reported that a male in his 20’s had a stroke after receiving the experimental vaccine.  Clinical trials in the U.S resumed in late October 2020. 

On January 29, 2021, company officials reported that overall, their COVID-19 vaccine was 66 percent effective at preventing moderate to severe symptoms, 85 percent effective at severe illness, and 100 percent effective at preventing COVID-19-related hospitalizations and deaths. 

Janssen/Johnson & Johnson COVID-19 Vaccine EUA

On February 27, 2021, the FDA issued an EUA for Janssen/Johnson & Johnson’s experimental vaccine for use in persons 18 years of age and older.  In clinical trials, the vaccine was reported to be 67 percent effective in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66 percent effective in preventing moderate to severe COVID-19 occurring at least 28 days after vaccination.  The vaccine, however, was reported to be only 42 percent effective in persons over the age of 60 with underlying health conditions. 

Common side effects reported after vaccine administration with the Janssen/Johnson & Johnson COVID-19 vaccine in clinical trials included injection site pain, headache, fatigue, myalgia, nausea, fever, injection site redness and swelling. 

Serious adverse events reported after vaccine administration included severe pain in the injected arm, hives, hypersensitivity, deep vein thrombosis, pulmonary embolism, transverse sinus thrombosis, severe generalized weakness with fever and headache, tinnitus (ringing or buzzing noises in the ears) and seizures. 

On April 13, 2021, the FDA and CDC paused use of the vaccine after serious blood clots were reported in women between the ages of 18 and 49.  By April 23, 2021, 15 cases and 3 deaths had been associated with the rare blood clot disorder, now referred to by health officials as thrombosis with thrombocytopenia syndrome (TTS). All cases were reported in women, with two occurring in women over 50 years of age. The CDC’s ACIP voted to resume full use of the vaccine in all persons 18 years of age and older on April 23, 2021, by a vote of 10 to 4 (with one voting member abstaining due to a conflict of interest). Those who voted against the recommendation expressed concern regarding the lack of warning on the risk of TTS in women under 50 years of age.   

On April 23, 2021, the FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet and acknowledged that: 

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”

By May 7, 2021, there had been 28 cases of TTS and 3 deaths confirmed by the CDC to be related to the Johnson & Johnson/Janssen COVID-19 vaccine. TTS was also reported in men and in women between 50 and 60 years of age, in addition to women between the ages of 18 and 49 years.  According to the CDC, TTS occurred at a rate of 1 case per 250,000 doses of the vaccine. 

On December 16, 2021, the CDC gave a preferential recommendation for mRNA COVID-19 vaccines in lieu of the Johnson & Johnson/Janssen COVID-19 vaccine due to the risk of TTS.  According to the CDC, use of the Johnson & Johnson/Janssen vaccine was advised to be limited to persons who were unable to or unwilling to receive an mRNA COVID-19 vaccine, or when no other vaccine option was available. 

A study conducted by the Mayo Clinic and published in the Journal of the American Medical Association in November 2021 found that individuals who received the Janssen/Johnson & Johnson COVID-19 vaccine were 3.7 times more likely to develop cerebral venous sinus thrombosis (CVST) in comparison to the rates prior to the pandemic. Women were over five times more likely to develop CVST after vaccination when compared to pre-pandemic rates of the condition, with the highest rates in women 40-49 years of age, followed by women 30-39 years. Most cases of CVST were reported within 15 days of vaccination. Researchers did not have an answer on why women were more susceptible; however, autoantibody production or other risk factors that place a woman at increased risk of CVST were thought to play a role. 

On July 12, 2021, the FDA announced that it would be issuing a warning that the Johnson & Johnson/Janssen COVID-19 vaccine could trigger Guillain-Barré syndrome (GBS). By July 2021, health officials reported 100 cases of GBS following vaccination, with 95 considered serious and requiring hospitalization, and this data included one death. According to the FDA: 

"Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship….Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks."

Per the CDC, rates of GBS within 21 days following the Johnson & Johnson/ Janssen COVID-19 vaccine were 21 times higher than after the Moderna or Pfizer/BioNTech mRNA COVID-19 vaccines. After 42 days following vaccination with the Johnson & Johnson/ Janssen COVID-19 vaccines, rates were 11 times higher than after the available mRNA COVID-19 vaccines. 

In early September 2021, the European Medicines Agency reported that its Pharmacovigilance Risk Assessment Committee (PRAC) was investigating a link between the Johnson & Johnson/Janssen COVID-19 vaccine and venous thromboembolism (blood clots in the veins). According to PRAC, in the initial clinical trials of the vaccine, a higher rate of venous thromboembolism was noted in the vaccine group when compared to the placebo group. Additional data collected from two larger clinical trials were expected to be submitted to PRAC in advance of vaccine marketing authorization, to determine whether the condition was linked to vaccination.   

The FDA updated the Johnson & Johnson/Janssen COVID-19 Vaccine Fact Sheet for Health Care Providers Administrating Vaccine on January 11, 2022 with information regarding the serious risk of immune thrombocytopenia (ITP) within 42 days of vaccination. ITP is a blood disorder that can cause excessive bruising and bleeding due to very low levels of platelets. 

Johnson & Johnson/Janssen COVID-19 Vaccine Production Concerns

On March 31, 2021, The New York Times reported that vaccine ingredients were mixed up by employees at an Emergent BioSolutions plant in Baltimore, resulting in up to 15 million ruined Johnson & Johnson vaccine doses. The mistake, which was determined by federal investigators to be the result of “human error”, was caught before any doses were released for distribution. The Baltimore plant was enlisted by the federal government in 2020 to manufacture vaccines developed by both Johnson & Johnson and AstraZeneca. While these vaccines use similar technologies, their ingredients and manufacturing processes are not interchangeable. According to The New York Times, in February 2021, one or more workers erred in the production process and this error was not discovered by Johnson & Johnson quality control checks for several days. 

This was not the first time that the Emergent BioSolutions Baltimore plant had been cited for errors. In April 2020, an FDA investigator had discovered that employees at the plant lacked adequate training, that testing protocols were not being followed, that records were not properly secured, and that policies to ensure that mix-ups or contaminations would not occur were found to be inadequate. Despite these safety issues, the plant was awarded $628 million by the U.S. government and also secured deals worth more than $740 million with AstraZeneca and Johnson & Johnson to manufacture COVID-19 vaccines for both companies at the Baltimore site. 

On April 20, 2021, the FDA cited the Baltimore Emergent BioSolutions plant for multiple quality control and sanitary issues, including their failure to adequately review and investigate the events that resulted in the manufacturing of 15 million botched Johnson & Johnson vaccine doses. Additionally, the FDA reported that they were not confident that previously released batches of the vaccines were not subject to cross-contamination. Unsanitary conditions at the plant included chipping paint from the walls in the hallways surrounding the manufacturing rooms, “brown residue” on walls, “black residue” and debris on the floor, and congested work areas. Plant employees were noted to be carrying unsealed bags containing medical waste and even “throwing unsealed bags of special medical waste into the service elevator accessing the warehouse corridor.” 

In November 2021, Emergent BioSolutions reported that it was no longer manufacturing COVID-19 vaccines for the U.S. Government. The decision to end the contract was related to manufacturing concerns at the Baltimore plant. The Baltimore facility, however, was reportedly continuing the manufacturing of the Janssen/ Johnson & Johnson COVID-19 vaccine for global distribution. The company’s actions during the pandemic were subjected to a congressional investigation and was reportedly involved in a lawsuit pertaining to concerns of insider trading among company executives. 

Johnson & Johnson/Janssen Booster Doses

A booster dose of Janssen/Johnson & Johnson vaccine was authorized by the FDA on October 20, 2021, for all individuals 18 years and older and was permitted to be administered at least two months following administration of the first dose.  The CDC, however, recommended mRNA COVID-19 vaccines over the Johnson & Johnson/Janssen COVID-19 vaccine due to the risk of TTS.  Immunocompromised individuals who received two doses of the Johnson & Johnson/Janssen COVID-19 vaccine were recommended to receive a third COVID-19 vaccine at least two months after the second vaccine dose. 

On September 1, 2022, the CDC voted to recommend use of either the Moderna or Pfizer-BioNTech booster dose in all persons 18 years and older who previously received the Johnson & Johnson/Janssen COVID-19 vaccine. This booster dose was recommended at least two months after the primary or latest booster dose. 

FDA revocation of the Johnson & Johnson/Janssen COVID-19 vaccine EUA

On June 1, 2023, the FDA revoked the EUA for Johnson & Johnson/Janssen COVID-19 vaccine. According to the FDA, Janssen BioTech had requested the voluntary withdrawal of its COVID-19 vaccine due to lack of demand for new lots of the vaccine, the expiration of last vaccine lots purchased by the U.S. federal government, and the decision by company officials to decline to update the vaccine to target new and emerging COVID-19 strains. 

Johnson & Johnson/Janssen COVID-19 Vaccine Profits

In January of 2022, Johnson & Johnson reported earnings of $2.4B from its COVID-19 vaccine in 2021. The company, however, reported weaker than expected earnings in 2022 and announced that it would no longer be including the vaccine’s revenue expectations in their projections. 

 

Novavax COVID-19 Vaccine

Maryland-based Novavax Inc, a biotechnology company which, prior to its COVID-19 vaccine, had never successfully delivered a product to market,  developed an experimental vaccine using recombinant nanoparticle technology. Referred to as a protein subunit vaccine,  NVX‑CoV2373 contains Novavax’s patented saponin-based Matrix-M™ adjuvant designed to enhance the immune response and stimulate high levels of neutralizing antibodies. 

Matrix-M1 contains nm (nanometers) of nanoparticles composed of Quillaja saponins, phospholipid and cholesterol. Quillaja saponins are chemical compounds extracted from the soapbox tree and are used as emulsifiers in food additives and beverages. 

Phase 1/2 clinical trials involved 131 participants, with 83 administered the NVX-CoV2373 vaccine containing the Matrix-M1 adjuvant to help stimulate an immune response to produce a strong antibody response.  Of the remaining trial participants, 25 were given the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant and 23 participants were given a placebo of sterile 0.9 percent normal saline. Participant received two intramuscular injections in the deltoid muscle administered three weeks apart. 

According to the results of the clinical trial, two of the 83 participants (one each in groups D and E) suffered “severe adverse events” (fatigue, headache, and malaise) after the first dose. Two participants—one each in groups A and E—had “reactogenicity events” (malaise, fatigue, and tenderness). Following administration of the second dose, one participant in group D had a “severe local event” (tenderness) and eight participants—one or two in each group—had “severe systemic events.” The most common of these severe systemic events were fatigue and joint pain. One participant in group D developed a fever greater than 100 °F. 

Phase 3 clinical trials of NVX-CoV2373 began in the United Kingdom in late September 2020. This trial, a randomized, placebo-controlled, observer-blinded trial, was expected to enroll up to 10,000 volunteers. Half of the volunteers would be administered two intramuscular doses of the experimental vaccine candidate 21 days apart, while the remaining participants would receive a placebo. 

On November 9, 2020, Novavax received “fast track” status from the U.S. Food and Drug Administration. This designation permitted the company to submit clinical data to the FDA when it became available rather than waiting for all results to be collected. 

In late January 2021, company officials reported that the experimental vaccine was 89.3 percent effective at protecting individuals from illness. This data was based on interim results of late-stage clinical trials conducted in the U.K. The vaccine, however, was found to be only 49.4 percent effective in South African clinical trials, where the B.1.351(Beta) variant was most predominant. 

By February 2021 Novavax had secured a memorandum of understanding with Canada  and Takeda Pharmaceutical Company Ltd.  (Japan) to produce the vaccine, while the European Medicines Agency (EMA) started their rolling reviews of the experimental vaccine.  As Phase 3 trials continued in the United States and the United Kingdom, Novavax had secured advance commitments and purchase agreements totally over 1.2 billion doses of NVX-CoV2373 with GAVI, The Vaccine Alliance (formerly the Global Alliance for Vaccines and Immunization);  Switzerland;  Australia;  New Zealand;  and Canada. 

On March 1, 2021, Novavax released pre-peer reviewed research results on their experimental NVX-CoV2373 vaccine. The Phase 2 component of their Phase 1/2 trial was a randomized placebo-controlled trial to identify dosing regimen for the vaccine.

Vaccine arms of about 250 participants received one or two intramuscular doses at 5-μg or 25-μg or placebo, 21 days apart. Subsequent to randomization, 45 percent of participants were 50 to 84 years of age, and side effects were reported as mild and lasted about three days, with intensification after the second dose with the higher dosage of the vaccine.

The lower dose antibody response was reported as 100 percent for all age groups with neutralizing antibody rates exceeding those present in convalescent sera. The study concluded by stating that the two-dose regimen at the lower dose of 5-μg was suited for young and old alike and was highly protective. 

In September 2021, Novavax company officials announced that it was initiating a Phase 1/2 study of a combination COVID-19-seasonal flu vaccine. The clinical trial would combine the Novavax recombinant protein-based NVX-CoV2373 COVID-19 vaccine with their NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single vaccine product.

Clinical trials would involve 640 healthy Australians between 50 and 70 years of age. Trial participants, however, must have previously been infected with SARS-CoV-2 or been vaccinated with an approved COVID-19 vaccine at least eight weeks prior to enrollment in the vaccine trial. Participants would be randomized to different cohorts to evaluate the safety and efficacy of different vaccine formulations and doses. Participants in the study were scheduled to receive two vaccine doses, spaced 56 days apart. 

In June 2022, the FDA’s Vaccine and Related Biologics Products Advisory Committee (VRBPAC) voted to recommend issuing Novavax an EUA for its COVID-19 vaccine for adults. VRBPAC made this recommendation despite the risks of myocarditis and pericarditis associated with the vaccine, as well as a lack of data on the effectiveness of the vaccine against the Omicron COVID-19 strain, the predominant variant in circulation at the time of the review. The FDA stated that the issuance of EUA would depend on an evaluation of Novavax’s manufacturing process. On June 3, 2022, Novavax had notified the FDA of a change to the manufacturing process of its COVID-19 vaccine. 

The FDA issued Novavax an EUA for its COVID-19 vaccine on July 13, 2022,  which was followed by a recommendation for use by the CDC. Novavax was authorized for use as a two-dose primary series in adults 18 years and older who had not previous received a COVID-19 vaccine.  According to the FDA, the vaccine was reported to be 90.4 percent effective at preventing mild, moderate, or severe COVID-19 illness. In persons 65 years and older, the vaccine was reported to be 78.6 percent effective. Clinical trials, however, were conducted prior to the emergence of the Delta and Omicron variants, and information on the vaccine’s effectiveness against these strains was not known.  In August 2022, the FDA expanded use of the vaccine in persons 12 years of age and older. 

In September 2022, the CDC recommended that individuals who received the Novavax COVID-19 vaccine series get a booster dose of an mRNA bivalent COVID-19 vaccine (either Moderna or Pfizer-BioNTech) at least two months following the second vaccine dose.  A booster dose of Novavax vaccine in persons 18 years and older who were unable to receive an mRNA COVID-19 vaccine, or in adults 18 years and older who would otherwise not receive a COVID-19 vaccine was authorized for use by the FDA on October 19, 2022. This booster dose was recommended to be given at least six months after completion of the primary COVID-19 vaccine series or most recent vaccine dose. 

 

Durability of Vaccine Acquired Immunity

In February 2021, the CDC stated that currently available mRNA COVID-19 vaccines would likely offer fully vaccinated individuals at least three months of vaccine-acquired immunity. In their quarantine guidance released on February 11, 2021, the CDC stated that fully vaccinated people (those who had received two doses of COVID-19 vaccine) who were exposed to SARS-CoV-2 through close contact would not be required to quarantine as long as vaccination had occurred within three months and they remained asymptomatic. 

However, in March 2021 the CDC’s website stated that it was not unknown how effective, or for what length of time the experimental COVID-19 vaccines would provide immunity against COVID 19 illness. The website also reported that it was also not known how effective the vaccine would be in mediating the severity of illness, should the vaccine fail to prevent COVID-19. 

On April 27, 2021, fully vaccinated individuals were still being told that they must stay at least 6 feet apart from others; wear masks in certain outdoor crowded public settings and indoor public settings; and when in gatherings with unvaccinated individuals. Vaccinated individuals were also being told to take precautions when visiting unvaccinated individuals who were at an increased risk for severe COVID-19 disease and to be vigilant about symptoms and get tested when they occur. The CDC, however, stated that vaccinated individuals could travel domestically and internationally without quarantining, and that pre- and post- travel testing was not required, unless the international destination required it. Persons entering the U.S., however, were still required to show a negative COVID-19 test result before boarding a flight and testing was still advised 3-5 days following international travel. 

In May 2021, the CDC announced that fully vaccinated individuals could resume activities without masking or physically distancing, except where required by law, workplace or local requirements. Additionally, they could travel domestically without testing or self-quarantine, and travel internationally without testing unless their destination required it, and would not be required to self-quarantine on return. Vaccinated persons exposed to someone with SARS-CoV-2 were also advised that they would not need to self-quarantine or test unless symptomatic. 

Since emergency use of the experimental COVID-19 vaccines was authorized by the FDA in December 2020, there have been multiple reports of fully vaccinated individuals testing positive for SARS-CoV-2.            

In early 2021, the CDC began reporting cases, hospitalizations, and deaths among fully vaccinated individuals. By April 30, 2021, the CDC reported 10,262 cases, 995 hospitalizations, and 160 deaths among persons who had been fully vaccinated, with the CDC acknowledging that the actually number of breakthrough cases were likely much higher due to the passive and voluntary system of reporting. 

In late April 2021, the CDC announced that it was only going to be reporting the number of breakthrough cases that resulted in hospitalization and death “to help maximize the quality of the data collected on cases of greatest clinical and public health importance.”  As a result, the public would not be made aware of the actual number of reported breakthrough cases occurring fully vaccinated individuals.

On July 27, 2021, the CDC issued a health alert and reported that fully vaccinated individuals could still become infected and be capable of transmitting the virus to others. Public health officials reported that the SARS-CoV-2 variants currently circulating in the U.S., especially the Delta variant, were highly transmissible and increasing the rate of infections. The CDC also recommended that all persons, including fully vaccinated individuals, wear masks in public indoor spaces in communities with high or substantial transmission rates. 

While this health alert reported that most COVID-19 cases, hospitalizations, and deaths were occurring in unvaccinated individuals,  data released from an outbreak in Massachusetts reported that 74 percent of cases had occurred in fully vaccinated individuals. Additionally, four of the five hospitalizations reported during this study occurred in fully vaccinated individuals. 

A study published in Science using data from the U.S. Veterans Health Administration published in early November 2021 reported that after six months, the effectiveness of all three available COVID-19 vaccines had significantly waned. The Moderna COVID-19 vaccine effectiveness decreased from an 89.2 percent effectiveness in March 2021 to a 58 percent effectiveness by September 2021. The Pfizer-BioNTech COVID-19 vaccine was reported to have decreased in effectiveness from 86.9 percent in March 2021 to 43.3 percent by September 2021. The Janssen/Johnson & Johnson COVID-19 vaccine decreased from an effectiveness of 86.4 percent in March 2021 to only a 13.1 percent effectiveness by September 2021. 

In the summer of 2023, the Informed Consent Action Network (ICAN), a non-profit dedicated to eradicating man-made disease, obtained FDA email communications pertaining to the effectiveness of COVID-19 vaccines in the first half of 2021 through a Freedom of Information Act (FOIA) request. These emails revealed that health regulators were aware that a data analysis compiled on 20 million Medicare beneficiaries had found that COVID-19 vaccine effectiveness waned rapidly within 5-6 months post vaccination for both infection and hospitalization in persons 65 years and older. The emails also reported that health officials knew that similar trends were emerging in the data among seniors who were 3-4 months post-vaccination.  

This data, however, was not revealed to the public during the August 2021 ACIP and September 2021 VRBPAC meetings convened to review and make recommendations on COVID-19 vaccine booster doses. Instead, data from the CDC’s COVID-NET, which showed the vaccine effectiveness against hospitalization to be 80 percent during the delta variant surge, was presented. Additional data, including studies on the Pfizer vaccine effectiveness in Israel, which showed the vaccine to be between 39 and 84 percent effective against infection and between 75 and 95 percent against hospitalization were also presented in lieu of the Medicare data analysis. 

Efficacy of the original COVID-19 mRNA vaccines

In February 2021, a study questioning the efficacy of COVID-19 vaccines expressed concerns regarding the absence of data on absolute risk reduction in the Pfizer-BioNTech and Moderna COVID-19 vaccine clinical trials. 

According to this study, the Pfizer-BioNTech COVID-19 vaccine showed an absolute risk reduction of 0.7 percent (95% CI 0.59% to 0.83%) and the study author, Ronald Brown, reported that 142 people (95% CI 122 to 170) would need to be vaccinated to prevent one case of COVID-19. The Moderna COVID-19 vaccine showed an absolute risk reduction of 1.1 percent (95% CI 0.97% to 1.32%) and 88 individuals (95% CI 76 to 104) would need to be vaccinated to prevent one COVID-19 case.

Brown concluded by noting that:

“A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.”

 

COVID-19 Vaccine Effectiveness against Omicron

The B.1.1.529 variant (Omicron), which was initially identified in early November 2021 in South Africa, was labeled a Variant of Concern by WHO on November 26, 2021. According to WHO, the variant was concerning because it contained a significant number of mutations  and might evade vaccine-acquired immunity.

A study from Denmark completed in late 2021 noted that fully vaccinated individuals were at greater risk of COVID-19 infection than unvaccinated, and those who received a booster dose were at an even greater risk of infection from the Omicron variant of COVID-19. 

In January 2022, a paper completed in Canada studied the data from person 18 years of age and older who had a PCR test for SARS-CoV-2 between November 22 and December 19, 2021. The study, which excluded long-term care residents and individuals who had received only one COVID-19 vaccine dose or who had received their second dose less than 7 days prior to being tested, reported:  

“…receipt of 2 doses of COVID-19 vaccines was not protective against Omicron infection at any point in time, and VE was –38% (95%CI, –61%, –18%) 120-179 days and –42% (95%CI, –69%, –19%) 180-239 days after the second dose. VE against Omicron was 37% (95%CI, 19-50%) ≥7 days after receiving an mRNA vaccine for the third dose. Findings were consistent for any combination of 2 mRNA vaccines and 2 doses of BNT162b2 for the primary series.”

The authors concluded that “two doses of COVID-19 vaccines are unlikely to protect against infection by Omicron. A third dose provides some protection in the immediate term, but substantially less than against Delta.”  

A CDC study published in February 2022 reported that after four months, a third dose of COVID-19 vaccine was significantly less effective at protecting a person against severe COVID-19 illness caused by the Omicron variant. According to this study, the effectiveness of the third dose against hospitalization dropped from 91 percent at two months to only 78 percent at four months. Effectiveness of the booster dose against urgent care or emergency room visits decreased from 87 percent at two months to 66 percent at four months. By five months, the effectiveness was found to be only 37 percent. 

A study published in the New England Journal of Medicine in June 2022 found that two doses of COVID-19 vaccine did not offer any protection against the Omicron variant and could potentially increase a person’s risk of infection. 

An article published in the New England Journal of Medicine in September 2022 found that children who had COVID-19 illness and were subsequently vaccinated with the Pfizer-BioNTech mRNA COVID-19 vaccine were more likely to get COVID-19 illness during the Omicron wave. Children who had not experienced a COVID-19 illness but received a COVID-19 vaccine were also more likely to become infected from the Omicron variant. Children with natural immunity from prior infection and who remained unvaccinated, however, were the least likely to become re-infected. 

A study completed in 2022 found that within 150 days, the effectiveness of the Moderna COVID-19 turned negative against the Omicron BA.2, BA.4, and BA.5 subvariants. Additionally, the study also found that against the Omicron BA.1.12.1, the vaccine turned negative within 91 days. Negative effectiveness means that a vaccinated individual is more likely to contract the virus. The study, which was conducted by researcher from Moderna and Kaiser Permanente, also found that persons who received three vaccine doses were more likely to become infected than those who only received two doses. 

A study published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) in November 2022 reported that the bivalent COVID-19 vaccines were less than 50 percent effective at preventing symptomatic COVID-19 illness. For individuals 65 years and older, the bivalent booster vaccine was reported to be only 32 percent effective in persons who received two primary doses. In those who received two primary doses and a monovalent booster before receipt of the bivalent booster, the effectiveness was only 19 percent. The bivalent vaccine was reported to be only slightly more effective in younger populations, but remained under 50 percent. This CDC sponsored study did not study the effects of the bivalent booster against severe disease, hospitalization, or death. 

Two studies conducted in the U.S. and released in late 2022 found that vaccinated individuals were more likely to develop COVID-19 infections.  One of the studies, found that the likelihood of COVID-19 infection increased with each subsequent dose and that unvaccinated individuals were least likely to become infected with COVID-19. 

 

Global Impact of COVID-19 Vaccines

An article published on September 30, 2021 in the European Journal of Epidemiology reported that vaccination has had no impact on COVID-19 rates. According to the published data that looked at COVID-19 cases in 68 countries and 2947 U.S. counties reported: 

At the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days. In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people.

Study authors recommended that strategies focusing on vaccination as a primary method of mitigating COVID-19 be re-evaluated.

A conducted primarily by Danish researchers and published in April 2023 found that mRNA COVID-19 vaccines have had no impact on reducing all-cause mortality in randomized controlled trials (RCTs). Scientists involved in the research found that mRNA COVID-19 vaccines were only protective against fatal infection, while adenovirus vaccines such as the Janssen/Johnson & Johnson vaccine "were associated with lower overall mortality and lower non-accident, non-COVID-19 mortality." The paper also found that while mRNA COVID-19 vaccines reduced COVID-19 deaths, the vaccine increased cardiovascular deaths, but that the data for either was not statistically significant. 

COVID-19 Vaccines and Mortality Rates

An analysis conducted for The Health 202 in the fall of 2022 reported a higher mortality rate in COVID-19 vaccinated individuals than those who were unvaccinated. According to the study, in August 2022, 58 percent of deaths occurred in individuals who were either vaccinated or vaccinated and boosted. This was an increase from earlier in the year, when an estimated 42 percent of deaths occurred among vaccinated people. 

 

Updated COVID-19 Vaccines for Fall 2023

In June 2023, the FDA’s VRBPAC met and voted to recommend that all COVID-19 vaccines manufactured for use in the United States be updated to target the Omicron XBB strain, with a preference for the XBB.1.5 strain. The FDA advised COVID-19 vaccine manufacturers that they should develop a monovalent COVID-19 vaccine to specifically target the XBB.1.5 strain for use in 2023-2024. 

On September 11, 2023, the FDA approved use of the Pfizer-BioNTech Comirnaty and the Moderna SPIKEVAX 2023-2024 COVID-19 vaccines containing the SARS-CoV-2 Omicron variant XBB.1.5 for use in individuals aged 12 year of age and older. The FDA also authorized use of a 3mcg dose of Pfizer-BioNTech 2023-2024 COVID-19 vaccine for use in children aged 6 months through four years of age, a 10mcg dose of Pfizer-BioNTech 2023-2024 COVID-19 vaccine for use in children aged five through 11 years of age, and a 25 mcg dose of Moderna 2023-2024 COVID-19 vaccine for use in children aged 6 months through 11 years of age.  One day later, the CDC recommended use of the vaccines for all persons six months of age and older. 

Approval for the vaccines manufactured and distributed by Pfizer-BioNTech was based on safety and efficacy data from clinical trials completed for COVID-19 vaccines containing the original SARS-CoV-2 virus and on trials of an experimental COVID-19 vaccine containing the original SARS-CoV-2 and Omicron variant BA.1.   

No human clinical trials were conducted on the Pfizer-BioNTech 2023-2024 COVID-19 vaccines prior to the September 11, 2023 FDA approval and authorizations. Pfizer-BioNTech company officials, however, reported that the vaccine elicited immune responses when tested on 20 female mice. 

The FDA approved and authorized the Moderna 2023-2024 mRNA COVID-19 vaccines based on safety and efficacy data from clinical trials completed on the COVID-19 vaccines containing the original SARS-CoV-2 virus and on trials of an experimental COVID-19 vaccine containing the original SARS-CoV-2 and Omicron variant BA.1.   

Additionally, Moderna conducted a clinical trial involving 101 individuals previously vaccinated with 3 doses of the original monovalent COVID-19 vaccine and one dose of bivalent COVID-19 vaccine. Fifty adult participants received a 50 mcg dose of a monovalent COVID-19 vaccine containing the SARS-CoV-2 Omicron variant XBB.1.5 and fifty-one participants received a dose of a bivalent COVID-19 vaccine containing 25mcg of SARS-CoV-2 Omicron XBB.1.5 variant and 25mcg of Omicron BA.4/BA.5.

According to the data published by company officials, fifteen days after receipt of the vaccine, individuals who received the monovalent COVID-19 vaccine containing SARS-CoV-2 Omicron variant XBB.1.5 had higher antibody response against the original SARS-CoV-2 virus, and the Omicron XBB.1.5 and Omicron XBB.1.16 variant than those who received the experimental bivalent booster. Most clinical trial participants reported both localized and system adverse reactions following vaccination. Researchers reported that no serious adverse events or deaths occurred among trial participants, however, data was limited to only 20-22 days post vaccination. 

The FDA issued an EUA to Novavax for its adjuvanted COVID-19 vaccine containing spike protein from the Omicron XBB.1.5 variant of SARS-CoV-2 on October 3, 2023.  No clinical trials of this vaccine were conducted prior to FDA authorization. Instead, federal regulators stated that the authorization of this updated vaccine was based on safety and effectiveness data from the original Novavax COVID-19 vaccine clinical trials and an experimental monovalent and bivalent Novavax vaccine, along with post-marketing data. The FDA justified the use of data from different vaccine products by stating that “the data accrued with these Novavax COVID-19 vaccines are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process.” 

No human trials were conducted on the Novavax COVID-19 vaccine targeting Omicron XBB.1.5. Novavax company officials, however, reported that this vaccine produced “robust neutralizing responses against XBB subvariants” in rhesus macaques. 

The FDA revoked the EUA for the original Novavax COVID-19 vaccine when it authorized use of the Novavax COVID-19 vaccine containing the Omicron XBB.1.5 variant. 

 

Ongoing Vaccine Development

AstraZeneca-University of Oxford COVID-19 vaccine

A vaccine development team from the University of Oxford in the United Kingdom endeavored to make an experimental COVID-19 vaccine candidate by the end of the summer of 2020. On April 23, 2020, human trials of the ChAdOx1 nCoV-19 experimental vaccine using a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein began. 

The University of Oxford reported that the initial clinical trials of ChAdOx1 nCoV-19 would involve 800 individuals. Half would receive the experimental vaccine while the other half would serve as the control group and receive a meningitis vaccine (MenACWY). 

Preliminary results of the AstraZeneca’s Phase 1 and Phase 2 trials were published in July 2020 in The Lancet.  This study involved 1,077 healthy adults between 18 and 55 years of age who were randomly given either the ChAdOx1 nCoV-19 vaccine (AZD1222) or the meningococcal conjugate (MenACWY) vaccine. Systemic and local reactions were reported to be more common in the trial group given the experimental COVID-19 vaccine, and a selection of participants from both groups received prophylactic paracetamol (acetaminophen) before vaccinations were administered.

In April 2020, Oxford University partnered with AstraZeneca to develop, manufacture, and distribute the ChAdOx1 nCoV-19 vaccine (now referred to as AZD1222) and U.S. Phase 3 clinical trials began in late August 2020. Their goal was to enroll 30,000 vaccine participants through 62 sites. On September 8, 2020, the pharmaceutical company announced that it was putting the trial on hold after a female participant in the U.K. developed transverse myelitis, a rare but serious neurological disorder, which causes inflammation of the spinal cord.  This was the second time that AZD1222 vaccine trials were placed on hold. In July 2020, trials were paused after a woman developed multiple sclerosis; however, company officials reported that her diagnosis was not related to vaccination. 

While clinical trials resumed quickly in several countries including Great Britain, Japan, South Africa, India,  and Canada,   trials in the U.S. remained on hold until October 23, 2020.  

On October 1, 2020, the European Medicines Agency (EMA) stated that it had started reviewing AstraZeneca’s COVID-19 clinical trial data in real time, and anticipated that following approval, all adults in Britain could receive at least one vaccine dose within 6 months. 

At the January 27, 2021 advisory committee meeting of the U.S. Centers for Disease Control (CDC), company officials from AstraZeneca reported that across the four studies, serious adverse events occurred in 168 participants, with 79 occurring among persons who received the experimental COVID-19 vaccine, and 89 among persons who received either the MenACWY vaccine or saline control. In total, 175 serious adverse events were reported; however, only four events were considered as possibly related to vaccination by clinical trial investigators. Company officials also reported that most solicited adverse events were mild to moderate and the majority resolved within a few days of vaccination. 

The European Union approved the vaccine for use in individuals 18 years and older on January 29, 2021, despite limited data to support its effectiveness in adults over the age 55 years. The University of Oxford and AstraZeneca’s COVID-19 vaccine was estimated to have an efficacy of about 60 percent. 

Health officials in South Africa halted use of the AstraZeneca COVID-19 vaccine after it was found to be less than 25 percent effective against the B.1.351 variant, the most common SARS-CoV-2 virus variant circulating in South Africa at the time. 

On March 12, 2021, CNN reported that while AstraZeneca, and UK and European regulators stated there was no evidence of this experimental COVID-19 vaccine causing blot clots, a number of countries suspended use of the vaccine. These countries included Denmark, Norway, Iceland, and Thailand. Other countries, including Austria and Italy chose instead to suspend specific batches of the vaccine, while Spain delayed rollout of the AstraZeneca vaccine. 

The World Health Organization (WHO) issued a statement on March 19, 2021 stating that their Global Advisory Committee on Vaccine Safety reviewed data on the vaccine in relation to blood clots and low platelets after vaccination and concluded that the rates of these events were fewer than when they occur naturally in the generalized population. The WHO added that these events would continue to be monitored. 

Soon thereafter, Canadian health officials joined France and limited the vaccine’s use in persons under 55 years of age, stating “From what is known at this time, there is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccine to adults under 55 years of age,” and had requested a new risk analysis on the vaccine’s risks and benefits broken down by age and gender.  On March 30, 2021, Germany limited the vaccine’s use to persons over the age of 60. 

On April 7, 2021, the European Medicines Agency (EMA) safety committee (PRAC) concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).” In their report, PRAC reminded health care professionals and vaccine recipients to be aware of the possibility of “blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination.” PRAC reported that the blood clots occurred in the abdomen (splanchnic vein thrombosis), brain (cerebral venous sinus thrombosis or CVST), and arteries, in conjunction with low levels of blood platelets and at times with bleeding. 

According to PRAC, “One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT).” New studies and revised protocols to ongoing clinical trials have been requested by safety officials. 

In the spring of 2021, German researchers described what they believed to be the two-step mechanism responsible for the serious clotting reaction following the AstraZeneca COVID-19 vaccine. According to the scientists, the first step involved the activation of blood platelets when they came into contact with the adenovirus outer shell and the proteins from the cells where the vaccine grows. When this occurred in large numbers, a signal would activate B-cells that then would produce an enormous number of antibodies against the platelet factor 4 protein, which is what assists to coordinate blood clotting. The body then believes that it is responding to a huge number of pathogens in the body, and causes antibodies to bind to the platelets, pull in white blood cells, and cause a systemic disruption. The second step involved the calcium-binder and stabilizer, EDTA, that is an ingredient in the AstraZeneca vaccine. EDTA reportedly causes the blood vessel walls to open up and permit entry of the protein and platelet complexes to begin circulation in the blood stream and triggers the syndrome. 

While many cases of the serious blood clotting disorder were reported to have occurred in women, lead author Dr. Andreas Greinacher reported that this disorder was not specific to one gender. Greinacher noted that since most health-care workers were women and part of the initial group of people to receive the vaccine, the tendency for cases to be reported among females was significantly higher. 

An in-depth review of 24 cases of splanchnic vein thrombosis and 62 cases of cerebral venous sinus thrombosis reported to the EU drug safety database, EudraVigilance, as of March 22, 2021 was completed by the committee. Of these cases, 18 were reported as fatal. The committee, however, continued to recommend the vaccine, stating that “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.” 

Vaccine use has resumed in many countries; however, some countries have restricted use of the product to persons over the age of 60 or 65 years of age.  In April 2021, Danish health officials announced that it was halting use of the vaccine after studies had noted that blood clots occurred at a rate of one in 40,000 people. 

By April 22, 2021, more than 220 cases of blood clots in conjunction with low platelets had been reported by European regulators following AstraZeneca vaccination. 

The AstraZeneca COVID-19 vaccine was also linked to Guillain-Barré Syndrome (GBS), a serious neurological disorder where the body’s immune system attacks the peripheral nervous system, and result in muscle weakness, paralysis, and even death. On September 8, 2021, the EMA stated that GBS should be listed as a potential adverse event following vaccination. According to the EMA, by July 31, 2021, 833 cases of GBS had been reported after AstraZeneca COVID-19 vaccination. 

In July 2021, AstraZeneca announced plans to seek full approval of the vaccine, rather than a fast-tracked status, in U.S.  However, in November 2022, AstraZeneca company officials announced that it had withdrawn its application for approval with the FDA, citing the ample availability of COVID-19 vaccines and the decreasing demand for the product. 

Inovio Pharmaceuticals INO-4800 DNA experimental vaccine

In early April 2020, Inovio pharmaceuticals began Phase 1 clinical trials of its experimental COVID-19 DNA vaccine, INO-4800. Inovio’s COVID-19 vaccine research had been funded by a $9 million grant from the Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and a $5 million grant from the Bill and Melinda Gates Foundation. It also has a partnership with Philadelphia’s Wistar Institute and Beijing Advaccine Biotechnology Co. in China to develop the vaccine in addition to a $11.9 million contract with the U.S. Department of Defense to provide the experimental DNA coronavirus vaccine potential use in military personnel. 

Inovio’s INO-4800 vaccine injects a small piece of circular DNA, called a plasmid (pGX9501), that encodes for the entire length of the Spike glycoprotein of SARS-CoV-2  to provoke the vaccine recipient’s cells into producing antibodies. The biggest challenge for DNA/RNA vaccines is getting patients’ cells to accept the introduced genetic material. Currently, the most effective technique appears to be electroporation, which is the delivering short pulses of electrical current to the patient to open cell pores and allow the plasmids to enter. This vaccine, unlike many of its counterparts, is stable at room temperature for over a year.    

On June 30, 2020, Inovio Pharmaceutical announced positive results from its Phase 1 clinical trials. Participants received either a 1.0mg or 2.0mg dose administered using INOVIO's CELLECTRA® 2000 device. According to company officials, all 10 reported adverse events were considered Grade 1 and involved localized injection site redness. 

INOVIO’s CELLECTRA® 2000 electroporation device delivers short pulses of electrical current to the patient in addition to the vaccine. The electricity creates temporary pores in a patient’s cell membranes and this process enables the DNA/RNA to enter.    The device is also associated with higher rates of injection site pain in comparison to standard injections.

In late September 2020, the U.S. Food and Drug Administration (FDA) placed the INO-4800 experimental vaccine trials on partial hold and requested more information on the clinical trials and the device used to deliver the vaccine. 

INOVIO announced in November 2020 that their INNOVATE Phase 2/3 randomized, blinded, placebo-controlled safety and efficacy trial would be funded by the U.S. Department of Defense and by December of 2020, the company had published Phase 1 clinical trial data suggesting that the vaccine generated both humoral (neutralizing antibodies) and/or cellular responses in CD4 and CD8 T cells. 

In October 2022, INOVIO company officials announced that it had discontinued trials of INO-4800 in the U.S. Trials of the vaccine candidate, however, were continuing in China through its partnership with Advaccine. 

 

COVID-19 Vaccine Development in China

Convidicea. CanSino Biologics, Inc. of Tianjin, China, in partnership with China’s Academy of Military Medical Sciences’ Institute of Biotechnology, also began development of a COVID-19 vaccine, Convidicea (Ad5-nCoV), that employs a chimpanzee adenovirus vector using the HEK293 cell lines derived from tissue of an aborted fetus. Phase 1 clinical trials of the CanSino vaccine enrolled 108 participants, where 87 of whom (81 percent) experienced at least one adverse reaction within seven days of vaccination. The most common reactions included headache, pain, fever, and fatigue. 

By December of 2020, Convidicea clinical trials had been launched in Saudi Arabia,  Moscow,  Mexico,  and Chile,  with advanced purchase agreements totaling 35 million doses. 

Pakistan and Mexico approved Convidicea under emergency prior to approval by any international health organizations and completion of Phase 3 trials in early 2021.   

CoronaVac. Beijing-based Sinovac Biotech Ltd began Phase 3 trials in July of CoronaVac, an inactivated coronavirus vaccine utilizing traditional vaccine manufacturing processes. To develop its vaccine, Sinovac obtained SARS-CoV-2 virus from patients globally, cultured and grew the virus in vero cells, which are derived from monkey kidneys. The virus was then inactivated with beta-propiolactone, a chemical derived from formaldehyde, and prepared and bottled as a vaccine. 

In September 2020, reports indicated that health officials in China had already begun administering experimental COVID-19 vaccines under their emergency use laws to their citizens prior to completion of Phase 3 clinical trials. Frontline healthcare workers, public officials, border security personnel, persons considered high-risk for COVID-19 infection as well as pharmaceutical company officials and their families were first to be given the experimental vaccines. Persons receiving the vaccines were required to sign a “nondisclosure agreement” which would prevent them from sharing any details to the media. 

On November 9, 2020, CoronaVac Phase 3 clinical trials were halted in Brazil due to a death that occurred in a vaccine trial recipient. Two days later, clinical trials resumed, and the death was reported as a suicide that was not related to vaccination. 

In December 2020, CoronaVac was reported to be 50.65 percent effective against COVID-19 illness in Brazil among health care workers 18 years of age and older. Company officials reported the vaccine to be 91.25 percent effective in clinical trials conducted in Turkey; however, this data was based on a preliminary analysis of only 29 cases. The Indonesia trial reported a vaccine effectiveness of 65.3 percent. China approved the vaccine for use by the general public in early February 2021.  By March 2021, CoronaVac became available for use in Tunisia, the Philippines, Mexico, Malaysia, Turkey, Indonesia,  and Brazil. 

In June 2021, China authorized CoronaVac vaccine for children between the age of 3 and 17 years.  By July 2021, company officials announced that a non-peer reviewed study found that the use of a third vaccine dose invoked a strong immune response and that adverse events were lower than those seen following the initial 2-dose series.

A study published in the Lancet reported an increased risk of Bell’s Palsy following CoronaVac vaccine but that the benefits of vaccination outweighed the risk. 

 

Russian COVID-19 Vaccine Development

A COVID-19 vaccine using viral vector technology, Sputnik V, developed in partnership between the Russian research institution, the Gamaleya National Center of Epidemiology and Microbiology, and the Russian Direct Investment Fund, received approval for widespread use by Russian authorities in early August 2020. Sputnik V uses two different strains of adenovirus and requires a second vaccine dose after 21 days to boost the immune response. The Lancet published data on the vaccine’s Phase 1/2 trials on September 4, 2020. Concerns about the lack of transparency related to pre-licensing clinical trial results had been expressed by some in the scientific community. 

On February 2, 2021, interim results from the Sputnik V (Gam-COVID-Vac) Phase 3 trials were published in The Lancet, which reported the vaccine to be 91.6 percent effective at 21 days following administration of the first vaccine dose (on the day that dose 2 was administered). Clinical trials of this vaccine included healthy adults 18 years of age and older who were negative for SARS-CoV-2 at baseline. Seventy serious adverse events were reported among 68 trial participants across both the vaccine group and the control group; however, trial investigators declared that none were related to vaccination. Four deaths occurred during the Phase 3 trials, three in vaccine recipients and one in the placebo group. No deaths were considered to be related to vaccination. Researchers report that the durability of vaccine acquired immunity is not known and it is not known whether the vaccine can halt transmission of SARS-CoV-2. 

In early February 2021, Russian vaccine developers reported that they were in discussions with China’s CanSino Biologics to study whether the second dose of the Sputnik V vaccine could be replaced with the COVID-19 vaccine manufactured by the Chinese vaccine maker. Vaccine researchers are looking to find out if combining COVID-19 vaccines made by different pharmaceutical companies could still offer adequate vaccine acquired immunity, or even better protection against the emerging virus variants. 

By March 2021, Sputnik V vaccine distribution agreements spanned more than 50 countries. On June 17, 2021, company officials reported that a booster dose targeting the Delta variant would soon be available. 

Sputnik V vaccine is approved for use in over 70 countries worldwide. 

 

How effective are COVID-19 vaccines?

vaccine effectiveness

To learn the history of the original monovalent COVID-19 vaccines developed for visit NVIC’s What is the history of COVID-19 vaccines in America webpage. 

At this time effectiveness of the 2023-2024 COVID-19 vaccine containing the SARS-CoV-2 Omicron XBB.1.5 variant is unknown, as effectiveness is based on real-world data of how the vaccine works in the general population and this vaccine has just been recently approved and authorized for use in the general population.

The vaccine efficacy for the 2023-2024 monovalent COVID-19 vaccine containing the SARS-CoV-2 Omicron variant XBB.1.5 is also unknown as clinical trial were not done prior to their approval for use.   Approval and authorization of these vaccines were based on clinical trial data from the original COVID-19 vaccine, as well as bivalent COVID-19 vaccines that were never approved or authorized for use.       

Vaccine efficacy is based on ideal situations like well-designed clinical trials. Notably, vaccine efficacy can differ from vaccine effectiveness because a vaccine may not work as well in the real world.     

Understanding what efficacy and effectiveness mean is also important. Below is an example from Yale Medicine.

“An example: Imagine there were 100 people in the vaccine group, and 100 people in the placebo group. If 10 people in the placebo group became infected, but only 2 in the vaccine group got sick, that means the vaccine has reduced the chances of illness by 80%; thus, it is considered to have an efficacy of 80%.” 

 

COVID-19 Vaccine Effectiveness in 2023

A study pending peer review that was conducted by the Cleveland Clinic in early 2023 found that during the time when Omicron variant XBB was the most dominant circulating strain, individuals who were up to date with the recommended COVID-19 vaccine doses (original 2-dose series, booster, and bivalent booster) were more likely to become infected with SARS-CoV-2 than those who were not.  A study published in September 2023 from COVID-19 illness rate data across 33 California prisons also noted that between January and July 2023, inmates who received the updated bivalent booster dose were more likely to contract COVID-19 illness than those who were not vaccinated. 

A research letter published by the Journal of the American Medical Association in September 2023 that looked at 177,000 emergency room (ER), urgent care (UC), and outpatient visits from July 2022 through May 2023 for infants and children 6 months through 4 years of age found that two doses of the Pfizer-BioNTech COVID-19 vaccine was associated with a decreased risk of ER and UC visits, but that three doses of the vaccine had no protective effect. No data was provided on the effectiveness of a single dose of the vaccine. Of note, three doses of Pfizer-BioNTech COVID-19 vaccine is the recommended primary series for all children aged 6 months through 4 years. The third dose was added after the initial clinical trials had begun when researchers discovered that two doses of the vaccine was not effective in this population.   

Multiple studies have found that vaccine effectiveness wanes quickly and vaccinated persons may be more at risk of infection.             

COVID-19 Vaccine Effectiveness Data from the CDC – September 2023

Data provided from the U.S. Centers for Disease Control and Prevention (CDC) in September 2023 also reports a rapid waning of protection from the vaccine.

The CDC also notes that vaccine effectiveness data is impacted by the rates of underlying infection acquired immunity in the population and that vaccine effectiveness “findings should be interpreted as the incremental benefit provided by COVID-19 vaccination in a population with high prevalence of infection-induced immunity.”  

Vaccine Effectiveness against ER/Urgent Care Visits (6 months through 5 years)

From data collected between July 2022 and August 2023, by two months following completion of the original 2 dose Moderna COVID-19 vaccine series, the vaccine was reported to be 24 percent effective in infants and young children against ER or urgent care visits. Similarly, from data collected between July 2022 and July 2023, by two months following completion of the original 3 dose Pfizer-BioNTech vaccine series, the vaccine was reported to be 16 percent in infants and young children. 

CDC health officials report that a booster dose of the bivalent COVID-19 vaccine in this population given between December 2022 and June 2023 was 61 percent effective at protecting infants and young children against ER and urgent care visits. Data, however, is limited because few children received booster doses of the bivalent vaccine and vaccine effectiveness over time was not made available.  

Vaccine Effectiveness in Immunocompetent Children (5 through 17 years)

From data collected between September 2022 and August 2023, three doses of the original monovalent COVID-19 vaccine were reported to be 7 percent effective against ER and Urgent Care visits in children and adolescents. A booster dose of the bivalent COVID-19 vaccine increased the vaccine effectiveness to 63 percent within the first 2 months, however, by 60 through 119 days post vaccination, the effectiveness had decreased to 36 percent. 

Vaccine Effectiveness in Immunocompetent Adults (18 through 64 years)

Between September 2022 and August 2023, three doses of the original monovalent COVID-19 vaccine were reported to be 2 percent effective against ER and Urgent Care visits in adults aged 18 through 64 years. A booster dose of the bivalent COVID-19 vaccine increased the vaccine effectiveness to 56 percent within the first 2 months, but by 60 through 119 days, the vaccine’s effectiveness had decreased to 39 percent. 

Three doses of the original monovalent COVID-19 vaccine in adults were reported to be 15 percent effective against hospitalization. A booster dose of the bivalent COVID-19 vaccine in immunocompetent adults was reported to increase the effectiveness to 61 percent within the first two months, but by four months, a bivalent booster dose in this population actually increased a person’s chance of hospitalization from COVID-19. 

Vaccine Effectiveness in Immunocompetent Older Adults (65+ years)

From data collected between September 2022 and August 2023, three doses of the original monovalent COVID-19 vaccine were reported to be 17 percent effective against ER and Urgent Care visits in immunocompetent older adults. A booster dose of the bivalent COVID-19 vaccine increased the vaccine effectiveness to 59 percent within the first 2 months, however, by 60 through 119 days post vaccination, the effectiveness had decreased to 47 percent. 

Three doses of the original monovalent COVID-19 vaccine in older adults were reported to be 25 percent effective against hospitalization. A booster dose of the bivalent COVID-19 vaccine in immunocompetent adults was reported to increase effectiveness to 67 percent within the first two months, but by four months, the effectiveness of this booster dose decreased to 28 percent. 

Vaccine Effectiveness in Immunocompromised Adults (18+ years)

Three doses of the original monovalent COVID-19 vaccine in immunocompromised adults were reported to be 1 percent effective against hospitalization and critical illness. A booster dose of the bivalent COVID-19 vaccine in this population was reported to increase vaccine effectiveness to 31 percent within the first two months, but by four months, the effectiveness of this booster dose decreased to 12 percent. 

 

Increase in COVID-19 Infection Following Vaccination

There is evidence that COVID-19 vaccination can increase a person’s risk of COVID-19 illness immediately following vaccination. A pre-print study posted in February 2021 that examined Israeli vaccination data reported that COVID-19 infection rates strongly increased following vaccination, nearly doubling, until eight days post vaccination. 

A published study that examined data from Public Health England found that within the first nine days following vaccination, an individual was 48 percent more likely to test positive for COVID-19 than unvaccinated individuals.  Higher rates of COVID-19 were also noted in the first 13 days post vaccination among individuals who received the COVID-19 vaccine in Qatar. 

 

Global Impact of COVID-19 Vaccines

An article published on September 30, 2021 in the European Journal of Epidemiology reported that vaccination has had no impact on COVID-19 rates. According to the published data that looked at COVID-19 cases in 68 countries and 2947 U.S. counties reported: 

At the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days. In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people.

Study authors recommended that strategies focusing on vaccination as a primary method of mitigating COVID-19 be re-evaluated.

A pre-print study pending peer review conducted primarily by Danish researchers and published in April 2022 found that mRNA COVID-19 vaccines have had no impact on reducing all-cause mortality in randomized controlled trials (RCTs). Scientists involved in the research found that mRNA COVID-19 vaccines were only protective against fatal infection, while adenovirus vaccines such as the Janssen/Johnson & Johnson vaccine "were associated with lower overall mortality and lower non-accident, non-COVID-19 mortality." The paper also found that while mRNA COVID-19 vaccines reduced COVID-19 deaths, the vaccine increased cardiovascular deaths, but that the data for either was not statistically significant. 

 

 

COVID-19 Vaccines and Mortality Rates

An analysis conducted for The Health 202 in the fall of 2022 reported a higher mortality rate in COVID-19 vaccinated individuals than those who were unvaccinated. According to the study, in August 2022, 58 percent of deaths occurred in individuals who were either vaccinated or vaccinated and boosted. This was an increase from earlier in the year, when an estimated 42 percent of deaths occurred among vaccinated people.34

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Can COVID-19 vaccines cause injuries and death?

vaccine injury death

According to the U.S. Department of Health and Human Services, adverse events are classified into five grades. The guidelines are as follows:

Grade 1 - Considered mild or asymptomatic and no intervention is required.

Grade 2 - A moderate event but minimal, local or noninvasive interventions are indicated. In some situations, certain activities of daily living are limited (shopping, meal preparations, using the telephone).

Grade 3 - Considered a severe or medically significant adverse event but not one that is considered immediately life-threatening. In certain cases, hospitalization, including long-term hospitalization is needed. Grade 3 reactions are disabling and limit a person’s ability to perform activities of daily living (feeding self, bathing, self-care). 

Grade 4 - A life-threatening event where urgent intervention is required 

Grade 5 - Death related to an adverse event

 

COVID-19 Vaccines in the U.S.

Under EUA authority, the FDA Commissioner may permit “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.”1

Most COVID-19 vaccines in use in the United States have an EUA status. To learn more about EUA products and vaccines and consumer rights, visit NVIC’s FAQ on Emergency Use Vaccines (EUA) & Vaccine Injury Compensation.

 

Pfizer - BioNTech Vaccine Trial Data

Original Pfizer - BioNTech Vaccine Trial Safety Data

More than 50 percent of adult participants involved in the Phase 1/2 human trials of Pfizer and BioNTech’s experimental messenger RNA (ribonucleic acid) COVID-19 vaccine reported adverse reactions. The trial was conducted in May and June 2020, and involved 45 healthy adults between the ages of 18 and 55 years. Limitations of this data were noted as not accurately reflecting populations at highest risk for COVID-19. 

In the trials, 12 adults received a 10-microgram dose of the BNT162b1 vaccine, 12 adults were injected with a 30-µg dose, 12 received a 100-µg dose, while nine adults were given an inert saline placebo. Within seven days of vaccination, seven (58.3 percent) of the participants in the 10-µg group reported adverse reactions (pain) near the injection site and 24–or 100 percent–in the 30-µg and 100-µg groups and two (22.2 percent) in the placebo group reported reactions. Severe pain was reported by one participant who received 100-µg dose.   

Three weeks after the initial vaccination with the Pfizer-BioNTech experimental vaccine, all clinical trial participants were given a second dose of the vaccine at the same dosage. Of the participants in the 10-µg group, 8.3 percent developed fevers. Of those in the 30-µg group, 75 percent developed fevers. More than 50 percent of the adults, who were given either a 10-µg or 30-µg dose, experienced an adverse reaction such as sleep disturbances and fever. Two participants suffered severe reactions. A Grade 3 fever of over 101.3°F two days after vaccination was experienced by one adult in the 30-µg group and sleep disturbance one day after vaccination was experienced by one adult in the 100-µg group.   

Pfizer reported early U.S. Phase 3 clinical trials results in mid-September. Company executives presented safety data for 5,664 individuals between 18 and 64 years of age, and 1,816 persons between 65 and 85 years who received one dose. In the younger age category, 16 percent reported chills, 35 percent complained of headache and 38 percent reported fatigue following vaccination. Eleven percent or less suffered diarrhea, joint pain, or chills. Side effects were reportedly lower among persons aged 65 to 85 years. 

After the second vaccine dose, 36 percent of trial participants between the ages of 18 and 64 reported fatigue, while 28 percent reported a headache and 18 percent reported muscle pain. Most adverse effects following the second dose were reported as mild to moderate; however, some participants did experience severe or life-threatening adverse reactions. Severe side effects occurred more frequently after the second dose. 

On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s messenger RNA (mRNA) COVID-19 vaccine for use in persons 16 years of age and older. 

The most commonly reported side effects associated with the vaccine included injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, malaise, and swollen lymph nodes.   

Additional adverse events reported in clinical trials included 12 cases of appendicitis (eight in the vaccine group vs. four in the placebo group), 70 cases of lymphadenopathy (64 in the vaccine group vs. 6 in the placebo group), and four cases of Bell’s Palsy, all in the vaccine group. 

In the data released at the December 10, 2020 Vaccines and Related Biological Products Advisory Committee meeting, six deaths were reported to have occurred during the clinical trials, two in the vaccine arm and four in the placebo arm. Of the two deaths in the vaccine arm, one person was reported as having a cardiac arrest 62 days post Dose 2 and the other was reported as atherosclerotic disease and died three days after Dose 1. 

Excess Adverse Events in Pfizer-BioNTech Vaccine Clinical Trials

A study published in Vaccine in September 2022 found that participants who received an mRNA COVID-19 were at a higher risk of experiencing a serious adverse reaction. The risk of an adverse reaction was higher than what was initially estimated at the time that the Pfizer-BioNTech mRNA COVID-19 vaccine was granted the EUA. According to the study, there were 10.1 additional events for every 10,000 individuals vaccinated and that 1 in 800 adults who received the Pfizer-BioNTech mRNA COVID-19 vaccine experienced a serious adverse event. 

Study authors also found that the risk of trial participants suffering a vaccine adverse event was greater than the reduction in COVID-19 related hospitalizations. 

 

 

Pfizer - BioNTech COVID-19 Clinical Trial Data in Adolescents

On May 10, 2021, the FDA expanded the EUA granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in the U.S. to include administration to children as young as 12 years old  and the CDC’s ACIP voted to approve its use in this population on May 12, 2021. 

The approval for use in adolescents 12 to 15 years was based on a small clinical trial involving 2,260 teens, of which 1,131 received the vaccine and 1,129 received a saline placebo.  According to the FDA’s Fact Sheet for Healthcare Providers Administering Pfizer-BioNTech COVID-19 Vaccine, the most common reported adverse events in adolescents 12 through 15 year olds included injection site pain, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling and redness, lymph node swelling, and nausea. 

During the clinical trial, nearly 11 percent of 12- to 15-year-olds experienced a severe or Grade 3 vaccine reaction, with one study participant experiencing a Grade 4 reaction of a fever of 40.4°C. Five adolescents who received the Pfizer vaccine experienced a serious adverse event (SAE) during the trial, however, none of these events were considered by clinical trial investigators to be related to vaccination. 

 

 

Pfizer-BioNTech COVID-19 Clinical Trial Data in Children

On October 29, 2021, the FDA authorized the use of a 10mcg dose of Pfizer-BioNTech COVID-19 mRNA vaccine in children 5 through 11 years of age. The vaccine was authorized to be administered intramuscularly as a two-dose series, three weeks apart.

The authorization of the vaccine was based on two cohort studies, involving 3,100 children who received the vaccine, and 1,538 children who received a placebo. Only 1,444 vaccine recipients were monitored for safety at least two months after the second vaccine dose. 

In the Cohort 1 study (C4591007) 1,518 children between the ages of 5 and 12 years received a vaccine dose, however, only 1,444 (95.1 percent) were followed for safety concerns at least two months after the second vaccine dose. The most frequently reported adverse events among Cohort 1 study participants included injection site pain (71 percent), fatigue (39.4 percent), and headache (28 percent). Most occurred after the second dose, and generally within two days of vaccination. Lymphadenopathy (swelling of the lymph nodes) was the most common unsolicited adverse event among children who received the vaccine (N=13 or 0.9 percent). Fourteen children who received the vaccine experienced a hypersensitivity reaction, compared to four children in the placebo group. These events primarily included dermatitis and rash. 

The Cohort 2 study involved 1,591 children who received the vaccine and 778 children who received the placebo. At the time of the data cutoff (Oct. 8, 2021), this population had only been monitored for 2.4 weeks post dose two. According to the FDA, data collection was ongoing. Among the 3,109 vaccine recipients in both Cohort studies, four serious adverse events occurred; however, all were considered by the trial investigators to be unrelated to vaccination. These included an upper limb fracture, an infection of the knee, a foreign body ingestion, and an epiphyseal fracture. One vaccine recipient, a six-year-old female, developed Henoch-Schonlein purpura 21 days post dose one but this adverse event was reported to be non-serious. No deaths occurred among any study participants. 

Additional unsolicited adverse events reported among vaccine recipients included swelling under the skin triggered by an allergic response (angioedema), administration site disorders, swelling of the face, skin and subcutaneous tissue disorders, urticaria, arthritis, musculoskeletal and connective tissue disorders, synovitis, eye disorder, conjunctivitis, injection site rash, skin and subcutaneous disorder, dermatitis, rash, and eczema. No cases of myocarditis or pericarditis were reported among study participants; however, there were 12 cases where chest pain was reported. Six cases occurred among those receiving the vaccine, and six among placebo recipients. 

There were no participants in Cohort 1 that withdrew from the clinical trial due to an adverse event; however, one participant in the Cohort 2 study withdrew following dose one due to fever and worsening of neutropenia (this individual had a prior diagnosis of benign transient neutropenia). 

Vulvar ulcers in adolescent girls between 12-16 years of age were also reported after the second dose of Pfizer-BioNTech COVID-19 vaccine. An April 2022 published case study found an association between the vaccine and genital ulcers, with symptoms presenting within 24 hours of vaccination. Additional reports of genital ulcers following vaccination have been reported in VAERS. 

 

Pfizer-BioNTech COVID-19 Clinical Trial Data in Infants and Young Children

On June 17, 2022, the FDA authorized use of a 3mcg dose of Pfizer-BioNTech COVID-19 vaccine for use in children six months through four years of age, to be given as a 3-dose series. According to the FDA, in children six through 23 months of age, the most common reported adverse events included fever and pain, redness, swelling and tenderness of the injection site, decreased appetite, and irritability. Similar reactions were noted among children ages two to four years of age, with the additional symptoms of chills, fever, and headache. 

Seventeen children aged six through 23 months of age experienced a serious adverse event (SAE) following receipt of the vaccine in clinical trials. SAEs included pneumonia, RSV bronchiolitis, gastroenteritis, rotavirus gastroenteritis, viral gastroenteritis, accidental overdose, febrile convulsion, seizure, lower respiratory tract infection, anal abcess, metapneumovirus infection, and anaphylaxis. According to the trial investigators, none of the SAEs were considered to be related to the vaccine. 

Twelve children aged two through four years of age were reported to have experience one or more SAEs during the clinical trial. These SAEs included dehydration, appendicitis, pain in the extremities, pyrexia, focal peritonitis, status epilepticus, epilepsy, febrile convulsion, viral gastroenteritis, rotavirus gastroenteritis, gastroenteritis, diarrhea, upper respiratory tract infection and lower respiratory tract infection. Trial investigators considered two SAEs, pyrexia and pain in the extremities, reported in a four-year-old trial participant, to be related to vaccination. This patient required treatment in the emergency department and hospitalization for several days due to persistant fever and moderate calf pain. 

 

 

Pfizer - BioNTech COVID-19 Vaccine and VAERS Reports

According to data released May 31, 2024 by the CDC, reports received by VAERS for the Pfizer-BioNTech experimental COVID-19 vaccine totaled over 958,438 vaccine adverse events with 215,495 categorized as serious. Noted within these reports were 23,419 deaths; 50,439 permanent disabilities; 143,699 hospitalizations; 93,192 emergency room visits, and 26,916 life threatening events. Also noted in these reports were that 778 deaths reported were categorized as senior living administration, with 91 percent of overall reported deaths occurring in persons 65 years of age and older.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to VAERS, many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence to suggest that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.      

 

Moderna mRNA COVID-19 Vaccine

Moderna COVID-19 Vaccine Trial Data in Adults

On May 18, 2020, Moderna, Inc. of Cambridge, Massachusetts announced that it had obtained “positive interim clinical data” from a Phase 1 human clinical trial of its experimental mRNA-1273 COVID-19 vaccine. However, four out of 45 healthy clinical trial participants experienced serious (Grade 3) vaccine reactions. 

Each of the 45 participants was given two doses of the Moderna vaccine about a month apart at dosage levels that were either 25, 100 or 250 micrograms (µg). The mRNA-1273 vaccine reportedly produced a “Grade 3 adverse event” in one participant who received doses of between 25 µg and 100 µg. That individual experienced Grade 3 erythema (a rash) around the injection site. A Grade 3 rash can include blistering, open ulcers, wet peeling (moist desquamation) or a serious rash over large areas of the body. 

Three participants in the clinical trial who received a vaccine dose of 250 µg experienced “Grade 3 systemic symptoms” following administration of the second dose. Moderna described these as the “most notable” of the adverse events and said that they had been “transient and self-resolving.”  

On July 27, 2020, the National Institutes of Health (NIH) announced that Phase 3 trials of Moderna’s mRNA-1273 had begun. According to the press release issued by NIH: 

“Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.”

In September 2020, three participants involved in the Phase 3 trial reported suffering reactions such as high fever, headaches, body aches and exhaustion. One participant suffered a bad headache, chills, a fever (over 100°F), and shortness of breath after getting the second vaccine dose, and described symptoms as “full-on COVID-like symptoms.”  Another of the trial participants, a woman in her 50s from North Carolina, suffered a migraine that “left her exhausted and struggling to focus.” 

On November 16, 2020, Moderna reported that adverse reactions were generally mild or moderate, and included headache, fatigue, and injection site pain 

The FDA issued an EUA for Moderna’s COVID-19 vaccine on December 18, 2020. In its press release, the FDA reported that during clinical trials, common reactions following Moderna vaccination included injection site pain, headache, fatigue, joint and muscle pain, fever, nausea, vomiting, and swelling of the lymph nodes in the arm where the vaccine was given. Vaccine adverse events typically persisted for several days and were more common following the second dose of the two-dose series. 

Serious adverse events occurring at higher rates in the vaccine group included myocardial infarction, kidney stones, gall bladder inflammation and Bell’s Palsy. Seven serious adverse events occurred in the vaccine group following vaccination, with four considered by clinical trial investigators to be related to the vaccine. These included intractable nausea and vomiting, rheumatoid arthritis, and two incidents of facial swelling that occurred in persons who had previously received cosmetic injections of dermal fillers. 

Thirteen deaths were reported during the clinical trials, with six occurring in the vaccine group and seven in the placebo group. In the vaccine group, two individuals over the age of 75 years with a history of heart disease died of heart related complications, two individuals were found deceased at home and the exact cause was not determined (a 56-year-old with a history of hypertension and chronic back pain being treated with opioid medication died 37 days after dose 1 and a 70-year-old with a history of cardiac disease was found dead 57 days after dose 2). One vaccine recipient died of suicide 21 days after dose 1, and a 72-year-old vaccine recipient with a history of Crohn’s disease and short bowel syndrome who was hospitalized for acute kidney failure and thrombocytopenia developed complications resulting in multiorgan failure and death 40 days after dose 2. 

A study published in November 2021 in the New England Journal of Medicine that examined the Phase 3 clinical trials noted that there were 17 deaths in vaccine group and 16 deaths in the placebo group. Additionally, study authors reported that one COVID-19 related death occurred among Moderna vaccine recipients and three COVID-19 related deaths occurred among placebo recipients.   

Excess Adverse Events in Moderna Vaccine Clinical Trials

A study published in Vaccine in September 2022 found that participants who received an mRNA COVID-19 were at a higher risk of experiencing a serious adverse reaction. The risk of an adverse reaction was higher than what was initially estimated at the time of the Moderna mRNA COVID-19 vaccine EUA in December 2020. According to the study, there were 15.1 additional events for every 10,000 individuals vaccinated and that 1 in 800 adults who received the Moderna mRNA COVID-19 vaccine experienced a serious adverse event. 

Study authors also found that the risk of trial participants suffering a vaccine adverse event was greater than the reduction in COVID-19 related hospitalizations. 

 

 

Moderna COVID-19 Vaccine Clinical Trial Data in Children and Adolescents

In June 2022, the FDA authorized use of two doses of a 100mcg Moderna COVID-19 mRNA vaccine in adolescents 12 through 17 years of age and two doses of a 50mcg Moderna COVID-19 vaccine in children six through 11 years of age under EUA. According to the FDA, the most common adverse events reported after vaccination during clinical trials included injection site redness, pain, and swelling, fever, chills, headache, nausea, vomiting, muscle and joint pain, fatigue, and swollen lymph nodes in the same arm of the injection. 

Twelve vaccine recipients aged 12 through 17 years of age experienced cardiovascular symptoms (chest pain, shortness of breath, and palpitations). This included a 12-year-old male who was hospitalized with chest pain, shortness of breath and abnormal EKG, three additional cases of shortness of breath, seven reports of syncope, and one report of palpitations. Forty-nine events of hypersensitivity reactions occurred among 46 vaccine recipients, and reported as injection site rash, hypersensitivity, dermatitis, and urticaria. No cases of anaphylaxis were reported. Additional adverse events included appendicitis, depression/suicidal ideation, drug-induced liver injury, and surgical repair of pectus excavatum. 

Adverse events of clinical significance reported among six through 11-year-old children who received the vaccine included epilepsy and seizures, loss of taste and smell, Tourette’s Syndrome, chest pain, shortness of breath, palpitations, musculoskeletal chest pain, vasovagal syncope, upper abdominal pain, suicidal ideation, oppositional defiant disorder, disruptive mood disorder, gastrointestinal disorder, asthma, synovitis, neck pain, epiphyseal fracture, Kawasaki Disease, ileus, and bradycardia. 

 

 

Moderna COVID-19 Vaccine Clinical Trial Data in Infants and Young Children

In June 2022, the FDA authorized use of a 25mcg Moderna COVID-19 mRNA vaccine in infants and children ages six months through five years, to be given as a 2-dose series. According to the FDA, the most common adverse events reported after vaccination in clinical trials included redness, swelling, and pain at the injection site, fever and underarm (or groin) tenderness and swelling of lymph nodes in the same arm or leg as the injection. In children aged 37 months through five years, the most common adverse events included headache, muscle ache, joint stiffness, fatigue, chills, nausea and vomiting. Among children ages six through 36 months of age, the most commonly reported side effects also included loss of appetite, irritability and crying, and sleepiness.  

Adverse events of clinical significance reported among children aged two through five-years who received the vaccine included erythema multiforme, seizure, chest pain, food allergy (egg), urticaria, rash, conjunctivitis, anaphylaxis, seizure, dyspnea, mental status change, chest pain, metapneumovirus, rhinovirus infection, adenovirus infection, Epstein-Barr virus infection, viral pneumonia, urinary tract infection, bronchial hyperactivity, and humerus fracture. In children aged six through 23 months, additional adverse events that occurred during clinical trials included a diagnosis of Type 1 diabetes, pyrexia with febrile seizure, metapneumovirus infection, rhinovirus infection, mastoiditis, erythema multiforme, electrolyte imbalance, bronchiolitis, febrile convulsion, adenovirus infection, asthma, croup infection, viral gastroenteritis, and cough with wheezing and urticaria.

 

Moderna COVID-19 mRNA Vaccine and VAERS Reports

According to the federal vaccine adverse event reporting system (VAERS), as of CDC’s May 31, 2024 release of data there were a total of 558,825 reports submitted to VAERS associated with the experimental Moderna COVID-19 vaccine. Noted within these reports were 82,175 serious events including 10,951 deaths; 16,691 permanent disabilities; 57,677 hospitalizations; 16,440 emergency room visits; and 9,970 life threatening events. Of the deaths reported to VAERS, 726 were noted as senior living administration settings, with over 91 percent of overall reported deaths occurring in persons 65 years of age and older.

 

 

Adverse Events Following mRNA COVID-19 Vaccine Administration

Health officials have cautioned that symptoms of adverse reactions following COVID-19 vaccination may overlap with those of COVID-19 illness and be difficult to distinguish. However, symptoms of loss of taste or smell, shortness of breath, cough, rhinorrhea or sore throat are not considered common vaccine reactions, and persons experiencing these symptoms post-vaccination may be positive for SARS-CoV-2 or another infection. 

Since the December 2020 EUA of COVID mRNA vaccines, additional serious adverse events have been identified and associated with use of the products.

COVID-19 mRNA Vaccines and Heart Inflammation

By the spring of 2021, multiple cases of pericarditis (inflammation of the membrane surrounding the heart) and myocarditis (inflammation of the heart muscle) following mRNA vaccination had been reported to health authorities.     Adolescents and young adult males were noted to be at highest risk, especially after the second dose. 

In data presented during the June 2021 Advisory Committee on Immunization Practices (ACIP) meeting, the CDC reported that in females between the age of 12 and 17 years, after the second dose, the case rate of myocarditis/ pericarditis was 9.1 per million doses administered. In males 12 to 17 years of age, however, the rate after the second vaccine dose was 66.7 per one million doses. Cases among females 18 to 24 years old after the second dose were reported at 5.5 per one million doses, while after dose two, males of the same age range were affected at a rate of 56.3 per one million doses. Most cases of myocarditis/pericarditis resulted in hospitalization, and while most were reported as being resolved, the long-term health outcomes were reported to be unknown.  

A January 2022 study conducted by the CDC and several universities found that the risk of myocarditis after receipt of an mRNA COVID-19 vaccine was 133 times higher than the normal risk of the heart condition in the general population. Most cases occurred among 16-17-year-old males following the second dose, at a rate of one in 9,500. The study also reported that 96 percent of individuals who developed myocarditis required hospitalization for their symptoms. While approximately 87 percent of persons hospitalized for myocarditis reported that symptoms had resolved at time of discharge from the hospital, the long-term effects are not known.  Additional studies have also associated mRNA vaccines with heart inflammation, with researchers reporting the need for further investigation.                       

A population-based cohort study published in the British Medical Journal in December 2021 found that the Moderna COVID-19 vaccine was four times more likely to cause heart inflammation than the Pfizer vaccine.  A study published in Nature Medicine in December 2021 reported that men under the age of 40 were more likely to develop myocarditis following Moderna vaccination than following SARS-CoV-2 infection. 

In October 2022, Dr. Joseph Ladapo, the Surgeon General of Florida recommended against the use of mRNA COVID-19 vaccine in males 18 to 39 years of age due to the risk of cardiac related deaths post-vaccination. According to an analysis of vaccinated Florida residents, males 18 to 39 years had an 84 percent increased risk of cardiac related death within 28 days of vaccination. 

The CDC, however, has declined to pause use or make changes to the vaccine recommendations, and they continue to report that the benefits to vaccination outweighed the risk. Additionally, they have stated that persons with a history of myocarditis and pericarditis can still receive an mRNA vaccine and persons who developed pericarditis after the first mRNA vaccine dose can choose to receive the second dose after symptoms resolve. The CDC has also advised that individuals who develop myocarditis after the first dose can consider a second dose of the vaccine under certain circumstances. No data has been provided to support this recommendation. 

Additional COVID-19 mRNA Vaccine Adverse Events

Since the issuance of the COVID-19 mRNA vaccines in December 2020, additional serious adverse events have been reported in the medical literature. These adverse events include shingles , Graves’ Disease (an autoimmune disorder affecting the thyroid),   blood clots,         stroke,       thrombocytopenia with thrombosis syndrome (TTS),   vaccine-induced immune thrombotic thrombocytopenia (VITT),          menstrual changes,   acute myocardial events,   kidney disorders,  erythema multiforme (allergic skin reaction characterized by red, raised, symmetrical areas over the entire body),  Central Nervous System (CNS) Demyelination, including multiple sclerosis (MS),  Hepatitis C reactivation,  Immune Thrombocytopenia (ITP),  Multisystem Inflammatory Syndrome (MIS),        tinnitus,    diabetes,    prion disease (a rare, fatal, transmissible spongiform encephalopathy),   functional neurological disorder,  capillary leak syndrome (a rare but serious condition where blood plasma leaks from the capillaries and causes a drop in blood pressure),  acquired hemophilia A (a rare autoimmune disorder),  Bell’s Palsy,  pemphigus vulgaris (rare auto-immune disease that causes blisters to the skin and mucous membranes),  Guillain Barre Syndrome (GBS),     transverse myelitis,  organ transplant rejection,    anaphylaxis,     and death.             

A report published in November 2022 in Clinical Research in Cardiology that reviewed autopsy reports of individuals who died suddenly in Germany concluded that COVID-19 vaccines were likely responsible for the sudden death. The researchers limited the study to individuals who did not have any underlying heart issues and those who died within 20 days of the first or second vaccine dose.   

Persons who have pre-existing immunity to SARS-CoV-2 may also be at increased risk of severe reactogenicity following mRNA COVID-19 vaccination. 

Children who receive the COVID-19 vaccine may be higher risk of illness from other viruses. An Australian study on 29 children aged 5 through 11 years who received the Pfizer COVID-19 vaccine were studied for their “in vitro cytokine responses” to several pathogens prior to and 28 days post-vaccination, with eight children also examined six months later. Researchers found a decrease in immune response to “S. aureusE. coliLmonocytogenes, BCG vaccine, H. influenzae, hepatitis B antigen, poly(I:C) and R848 stimulations” when compared to pre-vaccination. Researchers concluded that COVID-19 mRNA vaccines in children can alter cytokine responses to other viral pathogens and that repeated doses could place them at an increased risk of both viral and bacterial infections.   

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Safety of Updated COVID-19 Vaccines

In the fall of 2022, the FDA issued EUAs to both Pfizer-BioNTech and Moderna for bivalent booster dose of COVID-19 mRNA vaccine, containing the original Wuhan strain and the BA.4 and BA.5 SARS-CoV-2 Omicron variant for use in all individuals six months of age and older. Clinical trials of the vaccine were not required by the FDA and no safety data is available to support the use of these experimental products.        

Similarly, in September 2023, the FDA approved use of updated COVID-19 vaccines for 2023-2024 containing the SARS-CoV-2 Omicron variant XBB.1.5. The FDA did not require clinical trials of these vaccines prior to their approval and authorization. 

Moderna, however, conducted a clinical trial involving 101 individuals previously vaccinated with 3 doses of the original monovalent COVID-19 vaccine and one dose of bivalent COVID-19 vaccine. In this study, fifty adult participants received a 50mcg dose of a monovalent COVID-19 vaccine containing the SARS-CoV-2 Omicron variant XBB.1.5 and fifty-one participants received a dose of a bivalent COVID-19 vaccine containing 25mcg of SARS-CoV-2 Omicron XBB.1.5 variant and 25mcg of Omicron BA.4/BA.5. According to the study, most clinical trial participants reported both localized and system adverse reactions following vaccination. Researchers, however, reported that no serious adverse events or deaths occurred among trial participants but data was limited to only 20-22 days post vaccination. 

Pfizer- BioNTech Bivalent COVID-19 mRNA Vaccine Adverse Events

In January 2023, the FDA and CDC announced that they were investigating a potential link between the Pfizer-BioNTech Bivalent mRNA COVID-19 vaccine containing the original SARS-CoV-2 strain and the Omicron BA.4/BA.4 variant and ischemic stroke in persons 65 years and older. The possible safety signal, which was detected in the CDC’s Vaccine Safety Datalink (VSD), found an increased risk of stroke within the first 21 days after vaccination when compared to day 22-42. 

 

Impact of COVID-19 mRNA Vaccination of Placebo Group to Long-Term Clinical Trial Data

Long-term follow-up of clinical trial participants to monitor for conditions such as cancer and autoimmune diseases will become difficult, if not impossible. In December 2020, Pfizer-BioNTech officials stated that they would begin offering the vaccine to placebo recipients by March 1, 2021, which was several months earlier than what they had originally planned for.  By mid- January 2021, Moderna had already begun offering the vaccine to some placebo group participants. 

 

 

Janssen/Johnson & Johnson Adenovirus Vector COVID-19 Vaccine

On June 1, 2023, the FDA revoked the EUA for Johnson & Johnson/Janssen COVID-19 vaccine. According to the FDA, Janssen BioTech had requested the voluntary withdrawal of its COVID-19 vaccine due to lack of demand for new lots of the vaccine, the expiration of last vaccine lots purchased by the U.S. federal government, and the decision by company officials to decline to update the vaccine to target new and emerging COVID-19 strains. 

Janssen/Johnson & Johnson COVID-19 Vaccine Trial Data

In late September 2020, Janssen/Johnson & Johnson released results of the Phase 1/2a clinical trial for its Ad26.COV2.S vaccine. This study was a double-blind, randomized, placebo-controlled trial and included 796 participants divided into two groups consisting of 402 healthy adults 18 to 55 years of age in one group and 394 healthy elderly individuals 65 years of age and older in the other.

In this trial, the first group was broken out into cohort 1a and cohort 1b. The second group was cohort 3. Trial participants were administered a single intramuscular injection of Ad26.COV2.S at dose levels of either 5×1010 or 1×1011 viral particles (vp) per dose of vaccine.   

Approximately 58 percent of participants in cohorts 1a and 1b experienced a localized adverse event, while 64 percent of them also suffered systemic adverse events. Of the participants in cohort 3, 27 percent of them experienced a localized adverse event, and 36 percent suffered systemic events (e.g. fever, irritability, drowsiness, rash, etc.) Of healthy adults aged 18 to 55 years old in cohorts 1a and 1b, 19 percent came down with fevers, while four percent of the adults aged over 65 years old in cohort 3 developed fevers.    

The fevers reported by participants were considered mild or moderate and resolved within one to two days after vaccination. However, five percent (20 participants) of participants in cohorts 1a and 1b suffered from Grade 3 fevers of over 101.3°F.

A news report on the Janssen/Johnson & Johnson Phase 1/2a trial reported that

“[There were two severe adverse events recorded. One participant had hypotension; however, this effect is not related to vaccination as the participant had a history of hypotension. Another participant with fever was hospitalized as a suspected case of COVID-19; however, the fever resolved within 12 hours." 

The most common adverse events experienced by trial participants were headaches, muscle pain, fatigue and pain the injection site.    

On September 23, 2020, Janssen/Johnson & Johnson announced the start of its Phase 3 clinical trials. The trial, a randomized, double-blind, placebo-controlled study, would enroll up to 60,000 participants in three continents.  However, on October 12, 2020, all clinical trials stopped after a participant developed an “unexplained illness.”   Sources familiar with the event reported that a male in his 20’s had a stroke after receiving the experimental vaccine.  Clinical trials in the U.S resumed in late October 2020. 

On February 27, 2021, the FDA issued an EUA for Janssen/Johnson & Johnson’s experimental vaccine for use in persons 18 years of age and older. 

Common side effects reported after vaccine administration with the Janssen COVID-19 in clinical trials included injection site pain, headache, fatigue, myalgia, nausea, fever, injection site redness and swelling. 

According to the Fact Sheet for Healthcare Providers issued by the FDA, serious adverse effects (SAE) were reported in 0.4 percent of vaccine recipients and 0.4 percent of placebo recipients. Reported adverse events that occurred among the vaccinated included five cases of urticaria and an additional case of hypersensitivity that was not considered to be anaphylaxis. One vaccine participant reported severe pain in the injection arm that was not responsive to pain medication and another complained of fever, headache and weakness that resolved within three days. 

The Fact Sheet also reported more cases of thromboembolic events, pulmonary embolism, transverse sinus thrombosis, seizures, and tinnitus occurring in those who received the COVID-19 vaccine than those who received the placebo.

 

Janssen/Johnson & Johnson COVID-19 Vaccine and Blood Clots

On April 13, 2021, the FDA and CDC paused use of the vaccine after serious blood clots were reported in women between the ages of 18 and 49.  By April 23, 2021, 15 cases and 3 deaths had been associated with the rare blood clot disorder, now referred to by health officials as thrombosis with thrombocytopenia syndrome (TTS). All cases were reported in women, with two occurring in women over 50 years of age. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to resume full use of the vaccine in all persons 18 years of age and older on April 23, 2021, by a vote of 10 to 4 (with one voting member abstaining due to a conflict of interest). Those who voted against the recommendation expressed concern regarding the lack of warning on the risk of TTS in women under 50 years of age.   

The FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet on April 23, 2021 and acknowledged that: 

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”

By May 2021, there had been 28 cases of TTS and 3 deaths confirmed by the CDC to be related to the Johnson & Johnson/Janssen COVID-19 vaccine. Additionally, TTS has been reported in men and in women between 50 and 60, in addition to women between 18 and 49 years. 

Due to the risk of TTS following vaccination, ACIP voted in December 2021 to give a preferential recommendation to mRNA COVID-19 vaccines.  The CDC reports that TTS occurs at a rate of one case per 250,000 doses. 

In early September 2021, the European Medicines Agency reported that its Pharmacovigilance Risk Assessment Committee (PRAC) was investigating a link between the Janssen/Johnson & Johnson COVID-19 vaccine and venous thromboembolism (blood clots in the veins). According to PRAC, in the initial clinical trials of the vaccine, a higher rate of venous thromboembolism was noted in the vaccine group when compared to the placebo group.  

 

Janssen/Johnson & Johnson COVID-19 Vaccine and Guillain-Barré Syndrome (GBS)

On July 13, 2021, the FDA announced revisions to the Fact Sheet for Healthcare Providers administering the Janssen/Johnson & Johnson COVID-19 vaccine and the Fact Sheet for Recipients and Caregivers to include information regarding an increased risk of Guillain-Barré Syndrome (GBS) following vaccination. GBS, a serious neurological disorder where the body’s immune system attacks the peripheral nervous system, can cause muscle weakness, paralysis, and even death. According to the press release, the FDA reported 100 cases of GBS following vaccination, with 95 considered serious and requiring hospitalization, and one death. Government health officials noted that there was insufficient evidence to establish a causal relationship between the Johnson & Johnson/Janssen COVID-19 vaccine and GBS, and reported that “the known and potential benefits clearly outweigh the known and potential risks.” 

According to the CDC, rates of GBS following the Janssen/Johnson & Johnson COVID-19 vaccine were 21 times higher than after mRNA COVID-19 vaccines in the first 21 days post vaccination. After 42 days post vaccination, rates of GBS following the Janssen/Johnson & Johnson COVID-19 vaccine were 11 times higher.

 

Janssen/Johnson & Johnson COVID-19 Vaccine and Immune Thrombocytopenia

On January 11, 2022, the FDA updated the Johnson & Johnson/Janssen COVID-19 Vaccine Fact Sheet for Health Care Providers Administrating with information regarding the serious risk of Immune Thrombocytopenia (ITP) within 42 days of vaccination. ITP is a blood disorder that can cause excessive bruising and bleeding due to very low levels of platelets.168

 

Janssen/Johnson & Johnson COVID-19 and Transverse Myelitis

In January 2022, the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reported that a reasonable association existed between the Janssen/Johnson & Johnson and AstraZeneca, an additional adenovirus vector COVID-19 vaccine and transverse myelitis (TM), a rare but serious condition that involves inflammation of the spinal cord. Symptoms of TM include tingling, numbness, pain or loss of pain sensation, limb weakness, and issues with bowel and bladder function. According to PRAC, 38 cases of TM have been reported following adenovirus vector vaccines – 25 following the AstraZeneca COVID-19 vaccine and 13 following the Johnson & Johnson/Janssen vaccine.169

 

Janssen/Johnson & Johnson COVID-19 Vaccine and VAERS Reports

As of the May 31, 2024 data release, vaccine adverse events submitted to VAERS associated with the Johnson & Johnson/Janssen COVID-19 vaccine totaled 99,420, with 17,685 noted as serious. Included in these reports were 2,882 deaths; 3,443 permanent disabilities; 10,955 emergency room visits, and 12,402 hospitalizations.

 

Novavax COVID-19 Vaccine

Novavax COVID-19 Vaccine Clinical Trial Data

Maryland-based Novavax Inc, a biotechnology company which, prior to its COVID-19 vaccine, had never successfully delivered a product to market,  developed an experimental vaccine using recombinant nanoparticle technology. Referred to as a protein subunit vaccine,  NVX‑CoV2373 contains Novavax’s patented saponin-based Matrix-M™ adjuvant designed to enhance the immune response and stimulate high levels of neutralizing antibodies. 

Matrix-M1 contains nm (nanometers) of nanoparticles composed of Quillaja saponins, phospholipid and cholesterol. Quillaja saponins are chemical compounds extracted from the soapbox tree and are used as emulsifiers in food additives and beverages. 

Phase 1/2 clinical trials involved 131 participants, with 83 administered the NVX-CoV2373 vaccine containing the Matrix-M1 adjuvant to help stimulate an immune response to produce a strong antibody response.  Of the remaining trial participants, 25 were given the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant and 23 participants were given a placebo of sterile 0.9 percent normal saline. Participant received two intramuscular injections in the deltoid muscle administered three weeks apart. 

According to the results of the clinical trial, two of the 83 participants (one each in groups D and E) suffered “severe adverse events” (fatigue, headache, and malaise) after the first dose. Two participants—one each in groups A and E—had “reactogenicity events” (malaise, fatigue, and tenderness). Following administration of the second dose, one participant in group D had a “severe local event” (tenderness) and eight participants—one or two in each group—had “severe systemic events.” The most common of these severe systemic events were fatigue and joint pain. One participant in group D developed a fever greater than 100 °F. 

Phase 3 clinical trials of NVX-CoV2373 began in the United Kingdom in late September 2020. This trial, a randomized, placebo-controlled, observer-blinded trial, was expected to enroll up to 10,000 volunteers. 

On March 1, 2021, Novavax released pre-peer reviewed research results on their experimental NVX-CoV2373 vaccine. The Phase 2 component of their Phase 1/2 trial was a randomized placebo-controlled trial to identify dosing regimen for the vaccine.

Vaccine arms of about 250 participants received one or two intramuscular doses at 5-μg or 25-μg or placebo, 21 days apart. Subsequent to randomization, 45 percent of participants were 50 to 84 years of age, and side effects were reported as mild and lasted about three days, with intensification after the second dose with the higher dosage of the vaccine.

The lower dose antibody response was reported as 100 percent for all age groups with neutralizing antibody rates exceeding those present in convalescent sera. The study concluded by stating that the two-dose regimen at the lower dose of 5-μg was suited for young and old alike and was highly protective. 

In June 2022, the FDA’s Vaccine and Related Biologics Products Advisory Committee (VRBPAC) voted to recommend issuing Novavax an EUA for its COVID-19 vaccine for adults. VRBPAC made this recommendation despite the risks of myocarditis and pericarditis associated with the vaccine. 

The FDA issued Novavax an EUA for its COVID-19 vaccine on July 13, 2022,  which was followed by a recommendation for use by the CDC’s ACIP. Novavax was authorized for use in adults 18 years and older as a two-dose primary series who have not previous received a COVID-19 vaccine.  In August 2022, the FDA expanded use of the vaccine in persons 12 years of age and older. 

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Novavax COVID-19 Vaccine Side Effects

According to the Fact Sheet for Health Care Providers administering Novavax COVID-19 vaccine, the most common side effects reported following vaccination were injection site pain and tenderness, malaise/fatigue, muscle pain, headache, joint pain, nausea/vomiting, injection site redness and swelling, and fever. Serious side effects reported following Novavax COVID-19 vaccine include myocarditis, pericarditis, hypersensitivity reactions, chills, injection site itching and swelling of the lymph nodes. 

Novavax COVID-19 vaccines have also been associated with an increased risk of myocarditis and pericarditis. Additional serious cardiac adverse events reported in vaccine recipients included cardiomyopathy, cardiac failure and congestive heart failure.  Novavax COVID-19 vaccines have also been linked to cholecystitis (inflammation of the gall bladder, thrombotic and embolic events, and Guillain Barre Syndrome (GBS).

 

Novavax COVID-19 Vaccine and VAERS Reports

As of the May 31, 2024 data release, vaccine adverse events submitted to VAERS associated with the Novavax COVID-19 vaccine totaled 500 with 73 noted as serious. Included in these reports were 12 life-threatening reports, 50 hospitalizations, 18 permanent disabilities and 5 deaths.

 

Countermeasures Injuries Compensation Program Data

On Mar. 10, 2020, the Secretary of Health and Human Services (HHS) invoked the 2005 Public Readiness and Emergency Preparedness (PREP) Act, after declaring that the COVID-19 pandemic was a public health emergency. As a result, manufacturers of COVID-19 vaccines that have been developed to respond to the SARS-CoV-2 pandemic are considered public health emergency “countermeasures”. The PREP Act shields manufacturers and vaccine providers from liability and vaccine injury compensation claims will be processed by the Countermeasures Injury Compensation Program (CICP).     

All COVID-19 vaccines, including the licensed Pfizer and Moderna mRNA COVID-19 vaccines, are considered countermeasures. Persons harmed or who die as a result of vaccination may file for benefits through the CICP within one year of injury or death of a loved one. 

As of May 1, 2024, HRSA reports that 10,100 claims alleging injury or death following COVID-19 vaccines have been filed with the CICP. Additionally, 3,047 claims alleging injury or death following additional COVID-19 countermeasures (i.e. medications, treatments, testing) have also been filled. Of the 2,645 claims where HRSA has rendered a decision, only 51 claims were found to be eligible for compensation. Twelve claims have been compensated (nine for myocarditis, one for myopericarditis, one for syncope, and one for anaphylaxis following COVID-19 vaccination), 38 claims are pending a determination of benefits, and one claim has been found to have no eligible reported expenses.   The CICP has paid out a total of $43,386 for claims associated with COVID-19 vaccines as of May 1, 2024. 

HRSA has denied 2,594 claims, with 1,651 denied for missing the one-year filing deadline, 362 denied for non-receipt of medical records, 251 denied due to product considered ineligible for CICP benefits or due to non-specified reasons, and 330 claims denied due to the “standard of proof not met and/or covered injury not sustained.” 

IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who is at highest risk for complications from the COVID-19 vaccine?

vaccine complications

Outstanding Safety Concerns

Antibody Dependent Enhancement (Disease Enhancement)

For the past two decades, coronavirus vaccine research has been hampered by one consistent adverse outcome in particular - paradoxical immune enhancement or disease enhancement. This occurs because coronaviruses produce two different types of antibodies—neutralizing antibodies that fight the infection, and binding antibodies (or non-neutralizing antibodies) that cannot prevent viral infection. Incapable of preventing viral infection, binding antibodies can instead trigger paradoxical immune enhancement. This means that a person may seem fine until they contract the illness, and when this occurs, the disease is much more severe than it would have otherwise been.   

In the FDA briefings issued at the December 2020 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings for both the Pfizer-BioNTech and Moderna COVID-19 vaccines, the agency reported that:   

“Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.”

This information was also included in the Janssen/Johnson & Johnson FDA briefing document presented at the February 26, 2021 VRBPAC meeting in advance of the emergency use authorization approval. 

 

COVID-19 Vaccines and Heart Inflammation

Young males, especially those under the age of 40 years, are at a significant risk of myocarditis and pericarditis following COVID-19 mRNA vaccination.  In particular, males between 12 and 17 years of age are considered at highest risk, with most cases occurring within seven days of receipt of the second vaccine dose. Young women and older adults may also be at risk of heart inflammation; however, the rate is less than that of young males. 

In data presented during the June 23, 2021 Advisory Committee on Immunization Practices (ACIP) meeting, the CDC reported that in females between the age of 12 and 17 years, after the second dose, the case rate of myocarditis/ pericarditis was 9.1 per million doses administered. In males 12 to 17 years of age, however, the rate after the second vaccine dose was 66.7 per one million doses. Cases among females 18 to 24 years old after the second dose were reported at 5.5 per one million doses, while after dose two, males of the same age range were affected at a rate of 56.3 per one million doses. Most cases of myocarditis/pericarditis resulted in hospitalization, and while most were reported as being resolved, the long-term health outcomes were reported to be unknown.  

Multiple published studies have found an increased risk of heart inflammation following mRNA vaccination, especially in young adult males.        

A population-based cohort study published in the British Medical Journal in December 2021 found that the Moderna mRNA COVID-19 vaccine was four times more likely to cause heart inflammation than the Pfizer vaccine.  Additionally, a study published in Nature Medicine in December 2021 reported that men under the age of 40 were more likely to develop myocarditis following Moderna vaccination than following SARS-CoV-2 infection. 

In November 2021, Dr. Steven Gundry, a cardiologist and pioneer of infant heart transplant surgery, issued a warning regarding a significant increase in a common indicator of heart risk in individuals who received mRNA vaccines. The analysis, published in Circulation, notes that: 

"We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination."

According to Gundry, these significant changes places them at an increased risk for a new Acute Coronary Syndrome, which also includes heart attacks.

Novavax COVID-19 vaccines have also been associated with myocarditis and pericarditis. In vaccine clinical trials, seven cases of heart inflammation were reported, with five occurring within two weeks of vaccination. Four cases were reported in young males. The FDA reports that rates of myocarditis and pericarditis may be higher when the vaccine is administered in the post-authorization period. 

 

COVID-19 Vaccines and High-Risk Populations

Early COVID-19 vaccine clinical trials nearly exclusively enrolled healthy adults between the ages of 18 and 55 years. Few studies involve persons over the age of 65, or those with pre-existing health conditions.  As clinical trials expand, health status and age of trial participants and trial outcomes in at risk populations merit evaluation against any government use recommendations made for COVID-19 vaccines.

The Centers for Disease Control and Prevention (CDC) prioritized persons living in long-term care facilities (LTCF) in the initial phase of COVID-19 vaccine allocation even though this population was not studied in clinical trials. Vaccine safety and efficacy data on the use of COVID-19 vaccines in persons residing in LTCF remains unknown. The media have reported on deaths following vaccination in this population; however, public health officials have quickly dismissed any link to the COVID-19 vaccines.       

On July 2, 2021, the CDC acknowledged that no safety and efficacy data existed on the use of COVID-19 vaccines in persons with autoimmune disorders; in persons who are immunocompromised; and that data is insufficient relating to timing of vaccine for those who take medications that may lead to immunocompromised. The CDC, however, stated that persons with these conditions could still be vaccinated if they did not have a contraindication to vaccination. 

According to the Pfizer-BioNTech , Moderna , and Novavax  Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine  and SPIKEVAX mRNA COVID-19 vaccine  package inserts, individuals who are immunocompromised, including persons receiving immunosuppressive therapies, may not have an adequate immune response to vaccination

 

 

COVID-19 Vaccines in Pregnant and Lactating Women

There is little safety data available on the use of COVID-19 vaccines or mRNA vaccines in pregnant women and only limited data available from animal development and reproductive toxicity studies. The potential risk of these vaccines to pregnant women and the developing infant has not been fully studied and remains unknown. There is also limited safety data on the use of COVID-19 vaccines in lactating women. Information is lacking on the effects of mRNA or COVID-19 vaccines in the breastfed infant, or on milk production or excretion.          

In September 2022, the Journal of American Medical Association published a research letter that reported on the presence of mRNA COVID-19 vaccine in breast milk post-vaccination. This study looked at the breast milk from 11 lactating women, six who received the Pfizer-BioNTech mRNA COVID-19 vaccine, and five who received the Moderna mRNA vaccine, and found the presence of the vaccine in seven samples taken from five women up to 45 hours post-vaccination. Researchers expressed caution in breastfeeding infants under 6 months of age within 48 hours of vaccination and called for additional studies on the effects of vaccination on the breastfeeding women. 

A study published in September 2023 found the presence of a trace amount of vaccine mRNA in the breastmilk of 10 of the 13 lactating women involved in the study at least 45 hours post-vaccination. Study authors reported that the trace amounts found in the breastmilk did not express the SARS-CoV-2 spike protein in the breastmilk’s extracellular vesicles and concluded that breastfeeding was safe, especially 48 hours post vaccination. Researchers, however, noted that COVID-19 vaccine mRNA does not stay at the injection site, but can spread throughout the body. 

Despite a lack of data on the safety of COVID-19 vaccines use in pregnant women, on September 29, 2021, the CDC issued a Health Alert Network Advisory urging pregnant women to receive the COVID-19 vaccine. In their alert, the CDC stated that they were recommending COVID-19 vaccination in women who were pregnant, nursing, and in those who were planning on becoming pregnant “because the benefits of vaccination outweigh known or potential risks.” 

The CDC reported that while the absolute risk of COVID-19 disease in pregnant women is low, those who develop symptomatic illness were twice as likely to be hospitalized in the Intensive Care Unit (ICU), require mechanical ventilation, and 70 percent more likely to die. Additionally, the CDC acknowledged that transmission of the SARS-CoV-2 virus between mother and infant was exceedingly rare, occurring at a rate of 1 to 4 percent using rRT-PCR tests. However, rRT-PCR tests can only confirm presence of virus and not whether or not an individual is infectious. According to statements by the CDC in September 2021, 31 percent of pregnant women were reported to be fully vaccinated, a rate lower than that of the general population. 

Data from the newly released Pfizer-BioNTech mRNA COVID-19 vaccine trial data reported that 270 pregnancies were reported during the trials, but only 32 pregnancy outcomes were reported. Of the 32 known outcomes, 23 resulted in spontaneous miscarriages, two resulted in spontaneous miscarriages with intra-uterine death, two premature births resulting in death, one spontaneous abortion with neonatal death, and one normal outcome. Based on this data, of the 32 pregnancies with known outcomes, 87.5 percent resulted in the death of the fetus or infant. 

 

 

COVID-19 Vaccines and Menstrual Changes

Menstrual cycle changes have been reported following mRNA COVID-19 vaccines. These included reports such as heavy menstrual periods, menstruation following menopause, and breakthrough periods in women using birth control pills. A study of women who received COVID-19 vaccine published in July 2022 found that 42 percent of women experienced heavy menstrual periods after vaccination, while 66 percent of postmenopausal women reported breakthrough bleeding. 

On August 30, 2021, the National Institutes of Health (NIH) announced that it had award grants totaling $1.67 Million dollars to five institutions to study whether a potential link exists between COVID-19 vaccines and menstrual changes in women. In their press release, NIH noted reports of menstrual changes, including missed and irregular periods, heavier menstrual flows, and other changes had been reported by women who had received COVID-19 vaccines. The research will also look at the underlying mechanisms involved in the menstrual changes as well as the length of time the changes last. 

A study published in the journal Obstetrics & Gynecology on Jan. 5, 2022 found that COVID-19 vaccines caused menstrual changes in women, with more irregularities occurring among women who received two vaccine doses within one menstrual cycle. 

 

 

Risk of complications from COVID-19 Vaccines

The CDC cautions on the use of mRNA COVID-19 vaccines in persons who have a history of immediate allergic reaction to any injectable therapy or other vaccine, but state that the benefit of vaccination outweighs the risks in most individuals.  The CDC, however, reports that a risk assessment should be done prior to vaccination, and that the vaccination procedure should include a 30-minute observation period post-vaccination. Consultation with an allergist-immunologist is also advised by the CDC. 

In clinical trials, persons who have previously received dermal fillers experienced swelling at or near the site of filler injection. Persons with a history of receipt of dermal filler may be a higher risk of complications following mRNA COVID-19 vaccination. 

Persons who have pre-existing immunity to SARS-CoV-2 may also be at increased risk of severe reactogenicity following mRNA COVID-19 vaccination. In a study conducted by researchers from the Icahn School of Medicine at Mount Sinai, persons with pre-existing immunity to SARS-CoV-2 who received mRNA COVID-19 vaccines were found to have significantly higher rates of systemic reactions when compared to those who were not immune at the time of vaccination. Systemic reactions included fatigue, headache, chills, fever, joint or muscle pains.   

Children and adults with a history of Multisystem Inflammatory Syndrome (MIS-C and MIS-A) may be at an increased risk of adverse events following COVID-19 vaccine. There is a lack of information on the effects of COVID-19 vaccine in children with a history of MIS-C, a rare condition involving a dysregulated immune response following SARS-CoV-2 infection in children. Similarly, data is also lacking on the risks of COVID-19 vaccination on adults with a history of MIS-A, a similar condition to MIS-C. Despite the lack of safety data on the use of COVID-19 vaccination in this population, the CDC reports that experts consider the benefits of vaccination to outweigh any potential risks.  

The CDC, however, states that the decision to administer additional COVID-19 vaccines in children and adults who develop MIS following COVID-19 vaccination should involve consultation between the patient and/or guardian and the clinical care team or specialist. Consultation with Clinical Immunization Safety Assessment COVIDvax project may also be considered.  

 

 

Interchangeability of COVID-19 Vaccines

According to a study published in The Lancet on May 12, 2021, adults 50 years and older who received a mixed dose combination of the Pfizer-BioNTech vaccine and the AstraZeneca COVID-19 vaccines experienced more mild and moderate side effects than those administered only one type of vaccine. Systemic reactions, especially fever, were significantly higher after the second vaccine dose in persons who received the AstraZeneca vaccine followed by a dose of the Pfizer-BioNTech vaccine when compared to persons who received two doses of the Pfizer-BioNTech vaccine. There were also more reports of joint and muscle pain, chills, malaise, fatigue, and headache after the second vaccine dose in person who received a mixed dose schedule. 

In late October 2021, the FDA and CDC authorized the mixing of vaccine brand types for all persons receiving booster doses  despite limited safety or efficacy data to support the use of a mixed dose schedule.   

 

 

COVID-19 Booster Doses

In early January 2022, the European Medicines Agency (EMA) expressed concerns over repeat COVID-19 vaccine booster shots and their impact on the immune system. European drug regulators reported that use of a second booster dose may not be appropriate. Marco Cavaleri, head of vaccine strategy for the EMA, noted that the data has not been collected to support this approach, and that the agency would like to review data before making any recommendations. Further, the agency expressed concerns regarding a strategy that involved repeated vaccination within a short time period.

Cavaleri noted that the potential strategy of giving COVID-19 vaccine boosters every four months may lead to immune response issues, including the risk of overloading the immune system. 

 

 

Risk of Thrombosis with Thrombocytopenia Syndrome (TTS)

Individuals, especially women between the ages of 18 and 49, who receive the Janssen/Johnson & Johnson COVID-19 vaccine may be at risk for a serious and potentially fatal blood clot disorder condition known as thrombosis with thrombocytopenia syndrome (TTS).  In June 2023, the FDA revoked the EUA for Johnson & Johnson/Janssen COVID-19 vaccine. 

On April 13, 2021, the FDA and CDC paused use of the Janssen/Johnson & Johnson COVID-19 vaccine after serious blood clots were reported in women between the ages of 18 and 49. 

This blood clot disorder has also been associated with the AstraZeneca COVID-19 vaccine, another adenovirus vector vaccine, which has been authorized for use by the European Medicines Agencies (EMA). On April 7, 2021, the European Medicines Agency (EMA) safety committee (PRAC) concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). In their report, PRAC reminded health care professionals and vaccine recipients to be aware of the possibility of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. PRAC reported that the blood clots occurred in the abdomen (splanchnic vein thrombosis), brain (cerebral venous sinus thrombosis or CVST), and arteries, in conjunction with low levels of blood platelets and at times with bleeding. 

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to resume full use of the Janssen/Johnson & Johnson vaccine in all persons 18 years of age and older on April 23, 2021, by a vote of 10 to 4 (with one voting member abstaining due to a conflict of interest). Those who voted against the recommendation expressed concern regarding the lack of warning on the risk of TTS in women under 50 years of age.   

The FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet on April 23, 2021 and acknowledged that: 

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”

Due to the risk of TTS following vaccination, ACIP voted on December 16, 2021 to give a preferential recommendation to mRNA COVID-19 vaccines. 

On May 5, 2022, the FDA limited use of the Janssen/Johnson & Johnson COVID-19 vaccine to individuals for which other COVID-19 vaccines are not appropriate or not available, or for people who would not otherwise receive a COVID-19 vaccine. 

The Janssen/Johnson & Johnson COVID-19 vaccine is no longer available for use in the U.S. 

 

Risk of complications from Adjuvanted Novavax COVID-19 Vaccine

Individuals who experience an allergic reaction after a dose of Novavax COVID-19 vaccine should not receive another dose. Additionally, persons who are allergic to any component of the Novavax COVID-19 vaccine should not receive a dose due to the risk of adverse outcomes.63

 

Additional Outstanding Safety Concerns

Increased HIV infection risk

COVID-19 vaccines that use a recombinant adenovirus type-5 (Ad5) vector may increase the risk of HIV infection in males. In 2007, researchers testing an experimental HIV vaccine using an Ad5 vector to introduce HIV surface proteins into the body discovered that uncircumcised males who had been previously exposed naturally to adenovirus type-5 prior to receiving the experimental HIV vaccine were at an increased risk for developing HIV infection. 

Researchers have expressed concern that the use of any potential COVID-19 vaccine using an Ad5 vector may increase the risk of HIV infection and caution its use among populations vulnerable to the disease. 

Vaccine candidates that use Ad5 vectors include China-based CanSino Biologics COVID-19 vaccine and Russia’s Gamaleya Research Institute’s Sputnik V COVID-19 vaccine. Both experimental vaccines are involved in ongoing large-scale clinical trials globally.  On February 12, 2021, Hungary drug regulators approved the Sputnik vaccine through an emergency use authorization even though the vaccine had not yet been approved by the European Medicines Agency (EMA).  Pakistan has approved both the CanSino and the Sputnik V COVID-19 vaccines for emergency use. 

Potential Risk of Microvascular Injury

In December 2020, Dr. J. Patrick Whelan, M.D., Ph.D, a practicing pediatric rheumatologist treating children with Multisystem Inflammatory Syndrome (MIS-C), submitted public comment to the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to the December 10, 2020 review meeting of the Pfizer-BioNTech COVID-19 vaccine. In his comments, Whelan expressed concern that vaccines focused on creating immunity to the SARS-CoV-2 spike protein might actually result in injuries. In particular, he warned that the mRNA vaccines produced by Pfizer-BioNTech and Moderna had the potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver and kidneys in ways that were not assessed in the safety trials. 

Health care providers treating persons with COVID-19 illness have documented significant damage to other organs besides the lungs and include conditions such as neurological dysfunction, blood clots, heart inflammation, acute kidney disease, liver and intestinal damage. Despite disease impact on other organs of the body, in most cases, the virus is absent or limited. This appears to suggest that the spike proteins alone may be capable of causing significant damage throughout the body, without evidence of the virus.  

In his comment, Whelan stated that While there are pieces to this puzzle that have yet to be worked out, it appears that the viral spike protein that is the target of the major SARS-CoV-2 vaccines is also one of the key agents causing the damage to distant organs that may include the brain, heart, lung, and kidney. He urged that testing be done of the heart and even tissues of vaccinated individuals to assess the effects of the vaccine and warned that:  

“As important as it is to quickly arrest the spread of the virus by immunizing the population, it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on these other organs.”

COVID-19 Vaccines and DNA contamination

In the spring of 2023, researcher Kevin McKernan discovered the presence of both linear and plasmid DNA in vials of Pfizer and Moderna Bivalent COVID-19 vaccines. Plasmid DNA is used to program bacterial cells to produce mRNA in mass quantities and should not be found in the vaccine vial. Further, McKernan was able to confirm that this plasmid DNA was capable of transformation in bacterial cells.   

The presence of an SV40 (Simian virus 40) promoter sequence was also found within the vial. The SV40 promoter is a sequence that can turn on gene expression. Because the DNA is found in the lipid nanoparticles of the vaccine and can spread throughout the body and enter cells, DNA containing the SV40 promoter, if integrated into the genome, may have the potential to turn on the gene expression of a cancer-causing cell.  SV40 is a cancer-causing monkey virus that was administered to humans in the 1960s through contaminated poliovirus vaccines.  SV40 related cancers include brain cancers, bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma.   

McKernan’s findings were confirmed by Phillip Burkhaults, an expert in cancer genomics, and a professor at the University of South Carolina, who expressed concern of a very real theoretical risk of future cancer in some people, depending on where this foreign piece of DNA lands in the genome, it can interrupt a tumour suppressor gene or activate an oncogene. Burkhaults also noted that the presence of this foreign DNA in the body may be a possible mechanism for rare, serious adverse events, including sudden death after vaccination. 

Burkhaults did not find full SV40 virus in the vaccine, but confirmed the presence of a piece of SV40 in the plasma DNA. 

Persistent Presence of mRNA in the Body

While health officials reported that the lipid nanoparticles (LNP) found in the COVID-19 mRNA vaccines would remain at the injection site, studies have shown the widespread distribution of these particles throughout the body, including the brain.  Evidence provided to Japanese government officials by Pfizer note that LNP’s travel directly to the ovaries. 

Further, the mRNA found within the vaccines lasts much longer in the body than what government officials have reported.  Unlike natural mRNA that breaks down and disintegrates within minutes to hours, the synthetic mRNA found in COVID-19 vaccines remains stable in the body for weeks to months. This persistent modified mRNA continues to produce the Spike protein throughout the cells and tissues of the body for long periods of time. The result of the lingering mRNA is production of Spike protein in more tissues of the body for a much longer period of time. 

mRNA COVID-19 Vaccine Shedding

A study published in Immunohorizons in May 2023 found that individuals who received mRNA COVID-19 vaccines were capable of transmitting aerosolized antibodies to unvaccinated individuals. This study examined masks worn for one day by laboratory workers who received a COVID mRNA shot. Researchers found both Immunoglobulin G (IgG) and Immunoglobulin A (IgA) antibodies of SARS-CoV-2 on the masks and also concluded that droplet aerosolized antibodies could be passively transferred from immune and non-immune individuals.   

This study confirmed findings of previous studies that demonstrated that individuals who received COVID mRNA vaccines had high levels of intranasal IgG and IgA antibodies to the SARS CoV-2 virus and that these intranasal antibodies could be transferred to others through aerosols and respiratory droplets.    The authors of the study suggested their findings may indicate that COVID mRNA shots play a role in transferring passive immunity to SARS-CoV-2 to those who do not get the shot. 

The study also examined nasal swabs of children living with family members who received mRNA COVID vaccines, and compared them to nasal swabs of children living with family members who did not. SARS-CoV-2 specific IgG antibodies were readily detected in the nasal swabs of children living in households who received mRNA COVID shots. Additionally, there was a significant association between parents, who had a high number of SARS-CoV-2 specific intranasal IgG antibodies, and their children, who also showed a high number of intranasal IgA antibodies.  Antibodies, such as IgG and IgA, are proteins that are used by the body’s immune system to fight infections. 

A 2022 report in Infectious Disease Research hypothesized that individuals, who have received COVID vaccines that contain synthetic mRNA coated in lipid nanoparticles, could theoretically excrete and transmit lipid nanoparticles containing mRNA, the vaccine mRNA or the spike protein translated by the cells of the vaccinee to others. The authors suggest the synthetic mRNA coated in lipid nanoparticles—or the spike protein that the cells have been programmed to make—could be inhaled, absorbed transcutaneously or otherwise transferred to an individual who has not gotten a COVID shot. In other words, unlike traditional shedding and transmission of vaccine strain virus by live attenuated vaccines such as rotavirus, oral polio, or influenza vaccines, there may be excretion and transmission of the lipid nanoparticles containing mRNA of the virus or of the spike protein produced by the cells of those who get the shot. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

 

Who should not get the COVID-19 vaccine?

who should not get

Vaccine Contraindications

According to CDC’s interim clinical consideration guidelines for use of COVID-19 vaccines, contraindications to receiving the Moderna, Pfizer-BioNTech, and/or Novavax vaccine include a history of: 

  • Severe allergic reaction to any ingredient contained within the vaccine or after a previous dose of the COVID-19 vaccine;
  • Immediate allergic reaction of any seriousness to any ingredient contained within the vaccine (including polyethylene glycol [PEG) or diagnosed allergy to a COVID-19 vaccine ingredient.

The CDC also states that persons that have a contraindication to one of the mRNA COVID-19 vaccines should not receive a second dose, but may be able to receive another type of COVID-19 vaccine, provided precautions are followed. 

Below are the age groups authorized to receive COVID-19 vaccines, as approved or authorized by the U.S. Food and Drug Administration (FDA):

Pfizer-BioNTech/COMIRNATY

  • COMIRNATY mRNA vaccine (30 mcg) is FDA approved for use in persons 12 years and older. Persons under 12 years of age should not receive this vaccine. 
  • Pfizer-BioNTech mRNA vaccine (10mcg) dose is authorized for use in children five through 11 years of age under EUA status. Children under five years of age should not receive this vaccine. 
  • Pfizer-BioNTech mRNA vaccine (3mcg) dose is authorized for use in children six months through five years of age under EUA status. Children under six months or over four years of age should not receive this vaccine. 

Moderna/Spikevax

  • Spikevax mRNA vaccine (50mcg) is FDA approved for persons 12 years of age and older. Persons under 18 years of age should not receive this vaccine. 
  • Moderna mRNA vaccine (25mcg) is authorized under EUA for children six months through eleven years of age. Children under six months or over eleven years should not receive this vaccine. 

Novavax

  • Novavax COVID-19 vaccine is authorized under EUA for persons 12 years of age and older. Persons under 12 years of age should not receive this vaccine. 

Precautions

Myocarditis and Pericarditis

According to the CDC, there is insufficient data on the safety or efficacy of COVID-19 vaccine in persons with a past history of myocarditis and pericarditis. The CDC, however, has stated that persons with a history of myocarditis and pericarditis that is unrelated to vaccination be vaccinated once symptoms have fully resolved. 

In persons who develop myocarditis or pericarditis following receipt of an mRNA or Novavax COVID-19 vaccine, the CDC recommends that the second dose be deferred. The CDC, however, states that a second dose of mRNA vaccine can be considered in certain circumstances in this population following complete resolution of symptoms as determined by the patient’s healthcare provider. 

History of allergic reaction to other vaccines or injectable therapies

The CDC cautions on the use of COVID-19 vaccines in persons who have a history of immediate allergic reaction to any injectable therapy or other vaccine, but state that the benefit of vaccination outweighs the risk in most individuals.  The CDC, however, reports that a risk assessment should be done prior to vaccination, and that the vaccination procedure should include a 30-minute observation period post-vaccination. Consultation with an allergist-immunologist is also advised by the CDC. 

COVID-19 vaccination in person with a current or prior SARS-CoV-2 infection

Persons who have a current SARS-CoV-2 infection or those who have recently recovered from an infection are advised by the CDC to defer COVID-19 vaccination for at least 90 days from the date of the positive COVID-19 test or symptoms of illness. According to the CDC, studies have shown that an improved immune response has been found in persons who defer vaccination after SARS-CoV-2 illness. Additionally, the CDC notes that reinfection with the SARS-CoV-2 virus is uncommon in the weeks and months following SARS-CoV-2 infection. 

Immunocompromised Populations

According to the Pfizer-BioNTech , Moderna , and Novavax  Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine  and SPIKEVAX mRNA COVID-19 vaccine  package inserts, individuals who are immunocompromised, including persons receiving immunosuppressive therapies, may not have an adequate immune response to vaccination.

Per the CDC’s guidelines, persons considered moderately to severely immunocompromised may receive additional COVID-19 mRNA doses and the CDC reports that “the EUAs for Moderna and Pfizer-BioNTech COVID-19 vaccines allow healthcare providers flexibility for use of vaccine products, number of doses, dosage, and intervals between doses; alternative schedules within the parameters of the EUAs may be appropriate based on individual circumstances and clinical judgement.” 

A study published by the CDC in November of 2021 reported that 53 percent of immunocompromised individuals who were hospitalized with symptoms of COVID-19 vaccine were fully vaccinated. It is possible that the number of fully vaccinated may have been higher as the study excluded individuals who received a dose of the Janssen/Johnson & Johnson vaccine and those who had received their second mRNA vaccine dose less than two weeks before hospitalization. 

Previous History of Monoclonal Antibody or Convalescent Plasma Use

There is a lack of safety data on the use of mRNA COVID-19 vaccines in persons who have been treated for COVID-19 illness using monoclonal antibodies or convalescent plasma. Prior to February 11, 2022, as evidence appeared to indicate that reinfection with SARS-CoV-2 virus was uncommon within 90 days of initial infection, health officials recommended that COVID-19 vaccination be deferred for at least three months following receipt of antibody therapy due to active infection.  However, as of June 14, 2023, the CDC states that individuals who received monoclonal antibodies or convalescent plasma may receive COVID-19 vaccination at any time. 

History of receiving dermal fillers

Individuals with a history of previously receiving dermal fillers have experienced swelling near or at the site of filler injection after mRNA COVID-19 vaccine. While a history of receipt of dermal fillers is not a contraindication to receiving mRNA COVID-19 vaccines, the CDC advises that anyone who experiences swelling after vaccination should contact their health care provider immediately. 

Multisystem Inflammatory Syndrome in Children and Adults (MIS-C and MIS-A)

There is a lack of information on the effects of COVID-19 vaccine in children with a history of MIS-C, a rare condition involving a dysregulated immune response following SARS-CoV-2 infection in children. Similarly, data is also lacking on the risks of COVID-19 vaccination on adults with a history of MIS-A, a similar condition to MIS-C. Despite the lack of safety data on the use of COVID-19 vaccination in this population, the CDC reports that experts consider the benefits of vaccination to outweigh any potential risks.  

The CDC, however, states that the decision to administer additional COVID-19 vaccines in children and adults who develop MIS following COVID-19 vaccination should involve consultation between the patient and/or guardian and the clinical care team or specialist. Consultation with Clinical Immunization Safety Assessment COVIDvax project may also be considered.  

Pregnancy and Lactation

According to the Pfizer-BioNTech , Moderna , and Novavax  Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine  and SPIKEVAX mRNA COVID-19 vaccine  package inserts, there is insufficient data to determine the safety of COVID-19 vaccines in pregnant women, and it is not known whether these vaccines can cause harm to the mother or developing baby. There is also no safety data on the use of mRNA COVID-19 vaccines in lactating women, or the effects of the vaccine on the breastfed baby.          

In September 2022, the Journal of American Medical Association published a research letter that reported on the presence of mRNA COVID-19 vaccine in breast milk post-vaccination. This study looked at the breast milk from 11 lactating women, six who received the Pfizer-BioNTech mRNA COVID-19 vaccine, and five who received the Moderna mRNA vaccine, and found the presence of the vaccine in seven samples taken from five women up to 45 hours post-vaccination. Researchers expressed caution in breastfeeding infants under 6 months of age within 48 hours of vaccination and called for additional studies on the effects of vaccination on the breastfeeding women. 

A study published in September 2023 found the presence of a trace amount of vaccine mRNA in the breastmilk of 10 of the 13 lactating women involved in the study at least 45 hours post-vaccination. Study authors reported that the trace amounts found in the breastmilk did not express the SARS-CoV-2 spike protein in the breastmilk’s extracellular vesicles and concluded that breastfeeding was safe, especially 48 hours post vaccination. Researchers, however, noted that COVID-19 vaccine mRNA does not stay at the injection site, but can spread throughout the body. 

Vaccine Coadministration

No data is available on the safety of administering mRNA COVID-19 vaccines with other vaccines. When COVID-19 vaccines were initially authorized for use, CDC health officials recommended that COVID-19 vaccines be administered alone, and not within 14 days of receiving another vaccine. 

However, at the May 12, 2021 CDC ACIP meeting, health officials updated their guidance and stated that the COVID-19 vaccine could be co-administered with other vaccines, despite a lack of data to support this recommendation.    The CDC stated that their initial guidance recommending that COVID-19 vaccines be administered alone was not based on safety immunogenicity concerns, but rather out of an abundance of caution.  Data is lacking on the health outcomes and reactogenicity of individuals who receive COVID-19 vaccines with other routinely administered vaccines.

The CDC advises that young adult males who receive an orthopoxvirus (smallpox, monkeypox) vaccine such as ACAM2000 or JYNNEOS vaccine consider delaying COVID-19 vaccination for at least four weeks due to the risk of myocarditis and pericarditis.  Myocarditis and pericarditis have been associated with all COVID-19 vaccines (Moderna, Pfizer-BioNTech and Novavax)  and ACAM2000 smallpox vaccine.  There is also an unknown risk of myocarditis and pericarditis with JYNNEOS vaccine. However, if orthopoxvirus vaccination is recommended due to a potential monkeypox virus exposure, the CDC does not recommend the four-week delay between COVID-19 vaccination. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What questions should I ask my doctor about COVID-19 vaccines?

mother and child sitting with doctor

NVIC If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your loved one. If you review these questions before your appointment, you will be better prepared to ask your healthcare provider questions. 

Vaccine providers are federally required to provide vaccine recipients with the vaccine risk information, which can be found on the relevant FDA COVID-19 Vaccine Fact Sheet. Vaccine providers must also inform COVID-19 vaccine recipients that the vaccine may be decline and must providing information on consequences of declining the vaccine.

To be more fully informed about COVID-19 vaccines, FDA Fact Sheets are available to the public on the FDA's website, and NVIC encourages the public to read these fact-sheets prior to vaccination to assist consumers in making an informed vaccination decisions and for use in asking questions of vaccine providers. Because the FDA has granted all COVID-19 vaccines in use in the U.S. with an EUA status, all vaccine injury claims are governed by the Countermeasures Injury Compensation Program (CICP) and the U.S. Centers for Disease Control and Prevention (CDC) is not legally required to create a Vaccine Information Statement (VIS).  In this instance, the FDA issues Fact Sheets on EUA status vaccines which perform a similar function to the CDC’s VIS.

NVIC provides the public with referenced information on diseases and vaccines to empower informed decision-making and encourages consumers to further explore these references as vaccine decisions are made.

Additional questions to ask

Other questions that may be useful to discuss with your doctor before getting the COVID-19 vaccine are: 

  • What should I do if my child or I become ill after vaccination?
  • What other kinds of reaction symptoms should I call to report after COVID-19 vaccination?
  • If the coronavirus vaccine doesn’t protect me or my child, do we have any other options for preventing coronavirus infection?

In alignment with the informed consent ethic, which has guided the ethical practice of modern medicine, vaccine providers should answer your questions, and/or provide you with resources to learn more. The informed consent ethic, which is recognized globally as a human right, also states that individuals should be able to delay or refuse treatments and interventions without coercion or punishment. 

Under federal law, vaccine providers are required to report vaccine adverse events to the federal Vaccine Adverse Event Reporting System (VAERS) that is co-administered by the CDC and FDA.  You can learn more about reporting vaccine reactions on NVIC’s reaction reporting webpage and can also directly report vaccine reactions to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.

Vaccine Injury Compensation for COVID-19 EUA Vaccines

In the U.S., vaccine manufacturers are shielded from liability under the 2005 Public Readiness and Emergency Preparedness (PREP) Act for vaccines developed in response to a health emergency.   

The Secretary of Health and Human Services (HHS) invoked the PREP Act following the January 31, 2020 declaration of a COVID-19 pandemic public health emergency, stating that vaccines and drugs developed to respond to the coronavirus pandemic were covered countermeasures under the 2005 PREP Act. 

Individuals who die or suffer serious harm due to the administration of covered countermeasures, such as vaccines, may be eligible to receive compensation through the Countermeasures Injury Compensation Program (CICP),  whether the harm was a result of willful misconduct on the part of the vaccine manufacturer or person administering the vaccine.

The CICP is administered by employees in HHS’s Health Resources and Services Administration (HRSA). HHS regulations govern CICP’s procedures and eligibility determinations. In general, eligible individuals (or their survivors) who suffer death or serious physical injury directly caused by the administration of a covered countermeasure may receive reimbursement for reasonable medical expenses, loss of employment income and survivor benefits in the case of death. Serious physical injuries under CICP are generally limited to those that warrant hospitalization or result in a significant loss of function or disability. Congress funds CICP awards through emergency appropriations to the Covered Countermeasure Process Fund. 

The CICP currently governs all vaccine injury claims for COVID-19 vaccines in use in the U.S. and this program has been previously used when a public health emergency was declared for the H1N1 “swine flu” influenza pandemic in 2009 and for the Ebola virus outbreak in 2016.  

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice. 

 

NVIC Selected Resources, Statements and Commentaries Related to SARS-CoV-2 and COVID-19

NVIC Answers to Frequently Asked Questions

NVIC COVID-19 Articles & Reports

NVIC’s The Vaccine Reaction COVID-19 Articles

 

 

 

 

SARS-CoV-2 Virus & COVID-19 quick facts

covid-19

SARS-CoV-2 & COVID-19 Quick Facts

  • SARS-CoV-2 is one strain (type) of coronavirus that is part of a large family of enveloped RNA viruses that can infect mammals and birds.  Coronaviruses are named for their crown-like spiked surfaces and most often cause mild respiratory symptoms like the common cold in humans. 

  • A few coronavirus strains can cause very severe respiratory disease with significant mortality, such as Severe Acute Respiratory Syndrome (SARS) that emerged in China in 2002-2003  and Middle Eastern Respiratory Syndrome (MERS) that was first reported in Saudi Arabia in 2012.  SARS-CoV-2, which was identified in China in late 2019  and declared a global pandemic by the World Health Organization (WHO) in March 2020,    has a much lower mortality rate than SARS or MERS. 

  • People with SARS-CoV-2 infections can be asymptomatic  or exhibit a constellation of mild or severe illness symptoms known as COVID-19, which include fever; chills; cough; shortness of breath/difficulty breathing, fatigue; muscle, joint or body aches; rash; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting, and diarrhea.  Multiple studies have found that individuals who recover from COVID-19 illness have long-term immunity and rarely suffer a second COVID-19 infection.       

  • Complications of COVID-19 disease include pneumonia; acute respiratory distress syndrome (ARDS); acute kidney, liver, and heart failure or damage; septic shock; disseminated intravascular coagulation (DIC); rhabdomyolysis (muscle breakdown); chronic fatigue syndrome; blood clots and death.  Serious complications of COVID-19 occur when an infection triggers the immune system to flood the bloodstream with inflammatory proteins (cytokines) that can damage organs and kill tissue.  In some young children and adolescents, SARS-CoV-2 infections may trigger multisystem inflammatory syndrome (MIS-C).   

  • In 2020 about 94 percent of COVID-19 related-deaths occurred in persons over age 65 and individuals with underlying poor health conditions, with only about 6 percent involving healthy persons or in persons under the age of 65.  Those considered at highest risk for severe COVID-19 disease are the immunocompromised; pregnant women; individuals with chronic heart, lung or kidney disease; the obese; type 2 diabetics; and individuals with cancer, Down’s syndrome, sickle cell disease and thalassemia. Other conditions that may be at increased risk for severe COVID-19 disease include asthma, high blood pressure, dementia and neurologic conditions, liver disease, cystic fibrosis, and type 1 diabetes. 

COVID-19 Vaccine Quick Facts

  • On Mar. 10, 2020, the U.S. Secretary of the Department of Health and Human Services (DHHS) declared the COVID-19 pandemic a public health emergency and invoked the 2005 Public Readiness and Emergency Preparedness (PREP) Act. The public health emergency ended in the U.S. on May 11, 2023. However, COVID-19 vaccines remain a public health emergency “countermeasures” and continue to fall under the PREP Act, which shields manufacturers and vaccine providers from liability. The Countermeasures Injury Compensation Program (CICP) awards compensation to those injured by countermeasure vaccines.       

  • There are two COVID-19 vaccines for use in the U.S. Comirnaty mRNA COVID-19 vaccine,  developed and manufactured by Pfizer-BioNTech, and Spikevax mRNA COVID-19 vaccine,  developed and manufactured by Moderna. Both vaccines are monovalent mRNA COVID-19 vaccines containing the SARS-CoV-2 Omicron variant XBB.1.5. and are approved for use in individuals age 12 years and older.

  • Additional COVID-19 Vaccines available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines produced by Pfizer-BioNTech for use in infants and children aged 6 months through 4 years and for children five through 11 years of age  and one mRNA COVID-19 vaccine produced by Moderna for use in infants aged 6 months through 11 years.  There is one protein subunit vaccine, Novavax, authorized for use in individuals 12 years of age and older. According to the FDA, “Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”  An EUA status may be given for licensed, experimental, approved or conditionally approved vaccines and require that vaccine recipients must “have the option to accept or refuse the vaccine.” 

  • Serious adverse events associated with COVID-19 vaccines include myocarditis and pericarditis, Guillain-Barré syndrome (GBS), ischemic stroke, TTS,  shingles , Graves’ Disease (an autoimmune disorder affecting the thyroid),   blood clots,         acute myocardial events,   kidney disorders,  erythema multiforme (allergic skin reaction characterized by red, raised, symmetrical areas over the entire body),  Central Nervous System (CNS) Demyelination, including multiple sclerosis (MS),  Multisystem Inflammatory Syndrome (MIS),   tinnitus,    prion disease (a rare, fatal, transmissible spongiform encephalopathy),   organ transplant rejection,    anaphylaxis,     and death.             

  • Health officials have warned that, while there is evidence that COVID-19 vaccines can prevent symptomatic COVID-19 disease, there is a lack of evidence that the vaccines are effective in preventing infection and transmission of SARS-CoV-2.            Pfizer company officials have acknowledged that prior to EUA status, clinical trials were not conducted to determine whether the vaccine would stop transmission of the virus. 

  • As of the May 31, 2024 release of data from CDC, there have been 1,640,416 reports of adverse events following vaccination with COVID-19 vaccines submitted to the federal vaccine adverse event reporting system (VAERS), which noted 315,280 serious adverse events; 40,002 life-threatening events; 216,757 hospitalizations; and 37,647 deaths. Reported adverse events have included pain at the injection site; fatigue; anaphylaxis; headache; muscle and joint pain; fever; chills;  swollen lymph nodes; nausea and vomiting;  immune thrombocytopenia purpura (ITP) (low blood platelets);    Bell’s Palsy;  tinnitus;  cardiac arrest; neurological dysfunction; rheumatoid arthritis; blood clots; heart, kidney and liver failure;  anaphylaxis; myocarditis and pericarditis;   Guillain-Barré syndrome (GBS)  and death.      Click for most recent CDC data release.

Additional COVID-19 Information Resources

Food & Drug Administration (FDA)

Centers for Disease Control (CDC)            

National Institutes of Health – NIH

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more.

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more. 

Reporting a Vaccine Reaction

Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

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