Introduction

This Coronavirus (COVID-19) Pandemic Special NVIC Report published in 2020 and updated in 2021 is a collection of referenced news analyses, opinion essays and video commentaries researched and written by NVIC Co-founder and President Barbara Loe Fisher and published in NVIC’s weekly journal newspaper The Vaccine Reaction or the NVIC Newsletter.

In chronological order, the articles summarize information about major events and articles published in the medical literature and by the media after Chinese government officials announced on Dec. 31, 2019 that 44 patients with pneumonia of “unknown etiology” (unknown cause) had been identified in Wuhan, China.1 By Jan. 30, 2020, the World Health Organization (WHO) declared a “Public Health Emergency of International Concern” after confirming that a mutated coronavirus (COVID-19) was circulating in certain regions of China for which human populations reportedly had no natural immunity.2

On Jan. 31, 2020, the U.S. government declared a public health emergency.3 By the end of March 2020, all 50 states had declared a public health emergency that led to orders by most state Governors for citizens to self-quarantine at home and close businesses, schools, restaurants, shops and malls, churches, parks, beaches, gyms, sports arenas and other public spaces for at least four weeks, although some states extended the “lockdown” to up to 10 weeks.4 In December 2020, the U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA)5 to Pfizer/BioNTech6 and Moderna/NIAID 7 for two experimental mRNA COVID-19 vaccines to be distributed in the U.S., followed by an EUA issued to Johnson & Johnson/Janssen in February 20218 to distribute an experimental adenovirus vectored vaccine in the U.S.

By Apr. 8, 2021, more than 68,000 adverse event reports following COVID-19 vaccinations, including over 2600 deaths, had been reported to the federal Vaccine Adverse Event Reporting System (VAERS)9 10 created under the 1986 National Childhood Vaccine Injury Act, including high fevers, chills, headache, joint and muscle aching, disabling fatigue, cardiac and respiratory arrest, blood clots 11 and bleeding disorders, sudden death, seizures and neurological dysfunction and other types of adverse health outcomes.

Below are the topics covered by this special report:

The Science: Coronaviruses and COVID-19

  • History of Coronaviruses
  • COVID-19 Symptoms and Complications
  • High Risk Factors for Severe COVID-19
  • COVID-19 Mortality Statistics for Different Countries
  • Worst-Case Scenario Estimates for Mortality

U.S. Government Response

  • Declaration of Public Health Emergency by CDC
  • Recommended Precautions for Limiting Exposures
  • Social Distancing and Quarantine Measures
  • U.S. Federal and State Public Health Emergency Laws
  • U.S. Military Preparations to Execute Pandemic Plan
  • Infection and Antibody Testing for COVID-19
  • Delay in Testing for COVID-19 in U.S.
  • Shortage of U.S. Pandemic Preparedness Supplies

Fast Tracking of COVID-19 Vaccines Other Related Topics

  • Origin of New Mutated Coronavirus
  • Response of Chinese Government to COVID-19 Outbreak
  • COVID-19 Outbreaks on Cruise Ships
  • Oct. 19, 2019 Coronavirus Pandemic Simulation Exercise
  • Coronavirus Research in Biohazard Labs
  • Impact of COVID-19 Quarantines on U.S. & World Economy
  • Loss of Civil Liberties, Challenges to Ethical Principles
  • Fast-Track Development of COVID-19 Vaccines

NVIC Cononavirus (COVID-19) Pandemic Special Report

As new developments and broader public conversations about U.S. and global responses to COVID-19 take place, additional news analyses periodically will be added to this referenced special report on COVID-19. To learn more about SARS-Cov-2, COVID-19 disease, COVID-19 vaccines and public health policy and law related to the coronavirus pandemic, readers are encouraged to click on references anchoring essays in the articles of this report, which contain substantive information from many different original sources.

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.

U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies

NVIC Special Report on the COVID-19 Pandemic - Part 10

On June 15, 2022 the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) unanimously advised the FDA staff to grant Moderna and Pfizer/BioNTech an Emergency Use Authorization (EUA) amendment to allow their mRNA COVID vaccines to be given to children under age five and as young as six months. 1  2 3 Within 48 hours, the FDA approved the EUA amendment followed by a June 17-18 meeting of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control (CDC) that ended with a unanimous recommendation for both COVID vaccines to be given to all children in the six-month to five-year-old age group, which was immediately approved by the CDC’s Director. 4 5 National rollout of the reduced dose vaccines is underway this week and, with it, the US becomes the first country to give COVID vaccine to children under age two. 6

Natural immunity from SARS-CoV-2 infection has been documented to be robust and long lasting, 7 8 9 and the CDC estimated in April that about 75 percent of children ages 0 to 11 years old in the U.S. already had been infected. 10 After the CDC admitted in March that pediatric deaths from COVID were initially over-estimated, 11 a June 15 FDA briefing document stated that, “According to death certificate data, 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.” 12

The FDA briefing document confirmed that “many persons” with COVID are “presenting with asymptomatic or mild disease,” noting that symptoms in children are “generally milder” and as many as 50 percent of infections in children are asymptomatic.  The agency said that about half of the children four years old or younger, who were hospitalized with COVID, had one or more underlying health conditions. 13

Weak mRNA COVID Vaccine Efficacy for Young Children

FDA summary documents for both Moderna and Pfizer vaccines show weak efficacy, especially when considering that the FDA did not require COVID-19 vaccine manufacturers to demonstrate their vaccines prevent infection and transmission of the SARS-CoV-2 virus to obtain an EUA. 14 The companies were only required to demonstrate a minimum 50 percent efficacy in preventing severe COVID disease leading to hospitalization and death before the FDA granted an EUA to both companies in December 2020.

As the SARS-CoV-2 virus has evolved and created different variants over the past two years, COVID disease has been reported in a growing number of vaccinated people with quicky waning immunity, who are able to transmit the virus to others even though they are vaccinated. 15 16  On June 15, 2022, the Washington State Department of Health reported that, between Jan. 17, 2021 and June 4, 2022, over 500,000 reported COVID cases occurred in vaccinated persons in that state, with 17 percent of vaccinated persons reporting symptoms, two percent being hospitalized and 0.4 percent dying of COVID-related illness.17 

The clinical trial data from Pfizer and Moderna that the FDA used to green light administering mRNA COVID vaccines to very young children revealed that 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 Pfizer COVID vaccine, which is given in three doses containing three micrograms (one tenth the adult dose) with three weeks between the first and second dose and two months between the second and third dose, was tested in children aged six months to five years old. 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.”18

mRNA COVID Vaccines for Young Children: Safety Last

Knowing that the mRNA COVID vaccines do not reliably prevent infection and transmission of the SARS-CoV-2 virus, and that efficacy in preventing symptomatic COVID disease is marginal at best, have Pfizer, Moderna and the FDA and CDC demonstrated that it is safe to give mRNA COVID vaccines to all babies as young as six months old?  

According to the public statement issued by the FDA last week, there is a gap between what is known and is not known about mRNA COVID vaccine safety in young children:    

The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.” 19

The key words are “the known and potential risks.” There is lack of clarity and transparency on that point and one reason is because the release of this vaccine for babies as young as six months old is based on an EUA, not full licensure. This is the first vaccine to be recommended for and administered to babies in the U.S. on a mass basis that has not been fully licensed.

The June 18 public statement issued by the CDC did not contain any language about risk and only stated that,”COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history.” The CDC Director told doctors and parents that, “All children, including children who have already had COVID-19, should get vaccinated,” 20 a policy that was immediately endorsed by the American Academy of Pediatrics (AAP). 21  She gave that order even though the majority of babies and young children in America have already acquired natural immunity from prior infections, and even though the majority of children enrolled in the Moderna and Pfizer COVID vaccine clinical trials had not been previously infected with SARS-CoV-2. This means that the potential risks of giving mRNA COVID vaccines to babies and young children with a history of prior SARS-COV-2 infection (many asymptomatic) are unknown.

In 2013, an Institute of Medicine (IOM) committee confirmed that the safety of the CDC recommended childhood vaccine schedule from birth to age six has not been fully scientifically evaluated. 22 In the report The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies, 23 the committee stated, “key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines - have not been systematically evaluated in research studies.” The IOM committee also warned that:

“...evidence assessing outcomes in subpopulations of children, who may be potentially susceptible to adverse reactions to vaccines (such as children with a family history of autoimmune disease or allergies or children born prematurely) is limited and is characterized by uncertainty about the definition of populations of interest and definition of exposures or outcomes.  Most children who experience an adverse reaction to immunization have a preexisting susceptibility. Some predispositions may be detectable prior to vaccination; others, at least with current technology and practice, are not.”

Nothing appears to have changed in the past decade. On June 18, the ACIP Committee told doctors to give mRNA COVID vaccines at the same time with other CDC recommended childhood vaccines. Already, a six-month old baby can receive nine

vaccines and a 15- month old toddler can receive 11 CDC recommended vaccines on the same day. 24 

Where is the science evaluating the potential risks of adding a COVID shot to that mix?

Following is a June 15 response by Doran Fink, MD, PhD, Acting Deputy Director of FDA Office Vaccines Research & Review to a question from a VRBPAC temporary voting member about co-administration of COVID vaccines with other vaccines that he asked in light of the fact that pediatricians see “enhanced fever and even febrile seizures with coadministration of other vaccines together that all cause fever.” Dr. Fink’s reply confirmed that Moderna and Pfizer have not produced safety data regarding co-administration of their COVID vaccines to six-month old babies and young children: 25

“We have routinely requested coadministration studies in [unintelligble applications of vaccines that are intended for the very young infants, those who are younger than six months of age, because the immunization schedule is so compressed and it is difficult to avoid coadministration. We have not routinely requested or required coadministration studies for older children, but we have always encouraged that the manufacturers study safety and evaluate interference of coadministration when introducing a new vaccine into the pediatric schedule. We do expect that studies will be done going forward.”

mRNA COVID Vaccines Are Very Reactive

Pfizer, Moderna and federal health agencies have published information that both mRNA COVID vaccines are generally very reactive, with the majority of adults and older children experiencing local and systemic reactions within seven days of vaccination that can require a two to three day recovery period. 26 27 28 There are multiple articles in the medical literature documenting that mRNA COVID vaccines cause a very strong inflammatory response in the majority of people vaccinated, which is manifested by a range of symptoms, including fever, chills, injection site pain, fatigue, headache, and body aching. 29

Yet, the adverse reaction charts from clinical studies presented last week at the FDA and CDC advisory committee meetings for children under age five, especially for babies, suggest that there is little difference between the vaccinated and saline placebo groups for many commonly reported adverse events following the low dose Pfizer COVID vaccine, such as fever, irritability/crying, decreased appetite, drowsiness, headache, chills, diarrhea, and joint pain, with the exception that more reactions were reported after the second dose just like in older children and adults. 30 The Moderna vaccine, which uses a higher pediatric dose, more often showed a bigger difference between commonly reported reactions in the vaccinated and placebo groups. 31

But the dominant take-home message of the COVD vaccine clinical trial adverse reaction charts for younger children is that a whole lot of babies and toddlers are having fevers, chills, fatigue, irritability, headache and body pain even if they don’t receive the COVID vaccine. In some charts, the companies claim that the placebo group had more adverse events reported than the vaccinated group.

Whether the charts are accurate or not, the bottom line is that parents who choose to give their young children the Pfizer or Moderna mRNA COVID vaccine should monitor for any unusual physical, mental or emotional symptoms after vaccination. Parents know their children best and should not assume that health deterioration after COVID vaccinations has no relationship with the vaccine recently given, especially since increased reactions were noted for both vaccines after second doses. Vaccine adverse event symptoms that were looked at in the pre-EUA studies included high fever; irritability/crying; excessive sleepiness; pain, redness and swelling at injection site; refusal to eat; trouble breathing, rapid heart rate and chest pain (myocarditis); swollen lymph nodes; muscle aches; vomiting and diarrhea; trembling or jerking of the limbs (seizure) and respiratory infections following vaccination, all of which should be recorded in the child’s medical record.

More severe reactions, including hospitalizations, injuries and deaths, should be reported to the Vaccine Adverse Event Reporting System (VAERS). Since 1990, more than 2.1 million adverse events for all vaccines have been reported to VAERS by June 10, 2022, with more than 1.2 million of those adverse events associated with either the Pfizer or Moderna mRNA COVID vaccines. 32

Long Term Effects of mRNA COVID Vaccines Unknown

In addition to being the first vaccine to be fast tracked under an EUA rather than full licensure and given to millions of infants and young children in the U.S., mRNA COVID vaccine is also the first one to use an mRNA technology that has remained experimental until now. For example, Pfizer spent just 248 days testing their mRNA COVID vaccine using a never-before licensed technology, which injects synthetic mRNA encapsulated in lipid nanoparticles into the body to induce cells to make the SARS-COV-2 spike protein and become - in the words of the World Economic Forum - “vaccine production plants.” 33 34 To speed up the COVID vaccine testing process, FDA allowed Pfizer and other drug companies to conduct some of the animal and human clinical studies simultaneously, instead of sequentially. 35 To further accelerate approval, FDA also allowed companies to provide testing data from previous research on other types of experimental mRNA vaccines as preliminary proof that COVID mRNA vaccines were effective and safe, even though those other mRNA vaccines were never licensed. 36

Two years before Pfizer and Moderna got an EUA to distribute their mRNA vaccines, academic researchers warned of potential safety issues with the platform, like local and systemic inflammation; stimulation of hyper-inflammatory immune responses causing chronic inflammation and autoimmunity; and the presence of extracellular RNA that may cause edema and the formation of blood clots. 37 This is the first human vaccine to include lipid nanoparticles, which coat the synthetic mRNA in COVID vaccines and are highly inflammatory. 38  There are questions about biodistribution and a debate about whether those nanoparticles can accumulate in different organs of the body like the liver, spleen, lungs, kidneys and perhaps crosses the blood brain barrier, or end up in the ovaries and potentially affect fertility. 39

Myocarditis and pericarditis (inflammation of the heart) have been reported after both Pfizer and Moderna mRNA COVID vaccines, occurring most frequently in adolescent and young adult males and after the second dose. 40 Other severe adverse events reported in the medical literature include anaphylaxis and blood and immune mediated neurological disorders like Guillain Barre Syndrome (GBS). 41 The data evaluating these more serious adverse events in infants and young children is too limited to know how many children will exhibit signs of immune and brain dysfunction after receiving mRNA COVID vaccines.

During the public comment period of the day-long June 15 VRBPAC meeting, which can be viewed on You Tube, 42 most of the comments were made by mothers expressing fear and anger about the delay in making COVID vaccine available for their young children, which they have kept house-bound and masked children for two years. However, there were a few comments that opposed the EUA amendment, including Texas Congressman and attorney Louis Gohmert (at 5:07) who said, “There are many unanswered questions regarding the safety and efficacy of COVID vaccines, especially for babies and young children, and I am deeply concerned that the push to vaccinate these children is nothing more than a dystopian experiment with unknown consequences.” Sobbing through her testimony, mother Shae Lynn (at 5:16) described how an mRNA COVID vaccine reaction ruined her life, with doctors dismissing her symptoms and ignoring her pleas for help.  Expertly schooling the committee on what the FDA knew about the risks of mRNA vaccines but “did nothing” about, Sam Dodson (at 5:27) declared, “You have abjectly failed in your sole duty to ensure the safety of any drug given to Americans.”

78 Percent of Americans Have Gotten COVID Shots But Parents of Young Children Are Hesitant

By June 17, 2022, about 78 percent of Americans over age five had been given COVID vaccinations, 43 with about 222 million of them “fully vaccinated” according to the CDC and about 121 million having received one or two booster shots. 44 The CDC said the new COVID vaccine recommendation for babies as young as six months old will open up the market to about 20 million more children, but the agency noted that only about 29 percent of children ages five to 11 have been vaccinated since the Pfizer mRNA COVID vaccine was approved for that age group in November 2021. 45

An April 2022 poll revealed that four in 10 parents with children under age five are hesitant to give their young children COVID vaccine with 27 percent saying they will “definitely not” vaccinate their children and 11 percent indicating they will only do it if it is mandated. 46

 

Part I - Coronavirus Vaccines on Fast Track as WHO Declares Global Public Health Emergency

Feb. 5, 2020:  A novel strain of a coronavirus (2019-nCoV) was first detected in the city of Wuhan, China on December 31, 2019 and, by the middle of January, thousands of Chinese citizens were sick. According to Johns Hopkins University Center for Science and Engineering, as of Jan. 30, 2020 there had been 217 deaths among 9,776 confirmed coronavirus cases, with 92 of the cases identified in 20 countries other than China, including six cases in the U.S.1 On Jan. 30, the World Health Organization (WHO) declared the novel coronavirus outbreak, which began in Wuhan and spread to many cities in China, to be a “Public Health Emergency of International Concern.”2

Public health officials believe the origin of the outbreak can be traced to an unsanitary food market in Wuhan where live seafood, reptiles, animals and birds were sold for human consumption.3 The market was shut down the next day by health authorities. The WHO said the evidence suggested people consumed infected bats and snakes from the Wuhan market,4 but exactly which animal is the primary source of the outbreak is still not known.5  6

What is Coronavirus?

The WHO describes coronaviruses (CoV) as a large family of viruses that cause illness ranging from the common cold to more severe infectious diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).7 The new coronavirus (2019-nCoV) strain identified by health authorities has not been previously identified in humans.

Coronaviruses are zoonotic, which means they infect and can be transmitted between animals and humans.8  Investigations have found that SARS-CoV was transmitted from civet cats to humans,9 10 and MERS-CoV from dromedary camels to humans.11

There are several known coronaviruses circulating in animals that have not yet infected humans. Since health officials have not identified this latest strain in humans before, they have given it generic name of “a novel coronavirus” while investigations continue.

Symptoms of New Coronavirus Infection

The China coronavirus infection resembles viral pneumonia or influenza and common signs include fever, chills, sore throat, headache, muscle aches and respiratory symptoms, such as cough and breathing difficulties. According to the CDC:12

“The complete clinical picture with regard to 2019-nCoV is still not fully clear. Reported illnesses have ranged from infected people with little to no symptoms to people being severely ill and dying.”

Individuals can be incubating the infection for 10 to 14 days before symptoms begin, although it is unclear whether they are infectious during this time period.13

The CDC states that:14

“Typically, with most respiratory viruses, people are thought to be most contagious when they are most symptomatic (the sickest). With 2019-nCoV, however, there have been reports of spread from an infected patient with no symptoms to a close contact.”

Like with influenza, the majority of patients are recovering but, in some cases, the new coronavirus infection can cause complications like pneumonia, severe acute respiratory syndrome, kidney failure and death. Reportedly, the preliminary fatality rate associated with 2019-nCoV is about three percent but it appears to be higher in those over age 50, who have accounted for the majority of deaths in China.15 Older age groups are also at risk for complications of SARS and MERS, as well as influenza.

China Confirms Virus Can Spread From Human to Human

Initial reports out of China that the virus was unlikely to spread between humans were proven 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 as having infected as many as 14 medical staff in one hospital, gave evidence for the infection being spread more easily than initially thought.16

The U.S Centers for Disease and Prevention (CDC) states that much is unknown about how the novel 2019-nCoV spreads.17 Current knowledge is primarily based on what is known about similar coronaviruses. Most often transmission from person-to-person happens among close contacts (about 6 feet).

Person-to-person transmission is thought to occur mainly via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory infections spread. These droplets can potentially land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It is currently unclear if a person can get 2019-nCoV by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes.

Wearing masks to prevent transmission of 2019-nCoV may or may not work, depending upon the type of mask and how it is handled or if the virus can be contracted through eye exposure with infected droplets.18 The CDC is recommending frequent hand washing with soap and water for at least 20 seconds to help prevent transmission of this and most other infections.

High Level Biohazard Lab Opened in Wuhan in 2018

There have been several media reports stating that the outbreak may have originated from a laboratory that is part of China’s covert biological weapons program. The laboratory known as Wuhan National Biosafety Laboratory is the only declared site in China that permits working with deadly viruses.19

According to the Washington Times, Dr. Dany Shoham, a senior analyst with Israeli military intelligence for biological and chemical warfare in the Middle East and worldwide from 1970 to 1991 said that, “Certain laboratories in the institute have probably been engaged, in terms of research and development, in Chinese [biological weapons], at least collaterally, yet not as a principal facility of the Chinese BW alignment.”20 China has denied having or developing any dangerous biological weapons.

All researchers in the Wuhan high containment laboratory must change their clothing upon entering the facility, shower upon exiting and decontaminate all of the materials used during experimentation. Laboratory members wear full-body, pressurized suits to isolate themselves from the surrounding environment. The laboratory itself must be held in a separate building or an isolated wing within the surrounding university and must be supplied with its own air filtration and decontamination systems. 21

Over the past decade, there have been a number of reported security breaches in high containment biohazard labs around the world, including in the U.S., where bioterrorism and vaccine researchers are experimenting with lethal microbes and developing genetically engineered viruses and new vaccines.22 23 In 2014, the U.S. issued a temporary moratorium on U.S. funded research conducted in labs where scientists create more dangerous mutated forms of the SARS, MERS and influenza viruses that have the potential to start global pandemics in human populations if they escape from the labs.24 25 In 2017, that moratorium was lifted and the U.S. Department of Health and Human Services resumed funding researchers creating lab altered viruses that could spread quickly through human populations.26

Simulated Coronavirus Pandemic Exercise Held in October 2019

The Center for Health Security at John Hopkins University has a fictional pandemic simulation program to prepare communities for biological threats, pandemics and other disasters. On October 18, 2019, the Johns Hopkins Center for Health Security in partnership with the World Economic Forum and the Bill and Melinda Gates Foundation hosted Event 201, a high-level simulated coronavirus pandemic exercise in New York City.27 The exercise pointed out areas where international public/private financial partnerships will be required to respond to a pandemic in order to diminish large-scale economic and societal impact on countries around the world.

Participants in Event 201 were dropped in the middle of an uncontrolled novel coronavirus outbreak that was spreading like wildfire in South America and causing worldwide havoc. As fictional newscasters from "GNN" narrated simulated events, the immune-resistant virus (nicknamed CAPS) was crippling trade and travel, sending the global economy into free-fall. Social media was rampant with rumors and misinformation, governments were collapsing and citizens were revolting.

Those participating in the New York City pandemic simulation included a large group of public policymakers, pharmaceutical companies such as Johnson & Johnson; mainstream media outlets like NBC/Universal, business leaders and government health officials. Event 201 provided them with an opportunity to evaluate disaster response systems and whether current systems are strong enough or need to be expanded.

According to Johns Hopkins University, Dr. Eric Toner, senior scholar with the Center for Health Security said, “Once you're in the midst of a severe pandemic, your options are very limited. The greatest good can happen with pre-planning.”28

Coronavirus Vaccines Are Being Fast Tracked

In response to the coronavirus outbreak in Asia, drug companies and the National Institutes of Health (NIH) have begun working on a 2019-nCoV vaccine that will be fast tracked to licensure.29 Anthony Fauci, MD, director of the National Institutes of Allergy and Infectious Diseases has said that it would take a few months until the first phase of the clinical trials begins and more than a year until a vaccine might be available.

Dr. Fauci stated that, “When we were dealing with SARS, we developed monoclonal antibodies as potential therapeutics.”30 He added that, “Given the somewhat close homology between SARS and the new novel coronavirus, there could be some cross-reactivity there that could be utilized.”

 

Part II - Chinese Taken From Homes by Police to Coronavirus Quarantine Camps

Feb. 12, 2020: The New York Times on Feb. 6, 2020 was the first mainstream media outlet to report that Chinese government authorities responding to the country’s coronavirus epidemic had ordered round-the-clock house to house police searches to take the temperatures of all residents in Wuhan and detain anyone found to be 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 face “wartime conditions” and that “There must be no deserters, or they will be nailed to the pillar of historical shame forever.” 1

On Feb. 8 and 9, the UK newspaper Daily Mail posted a video filmed in Wuhan 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 shout out in protest and unsuccessfully struggle to break free. 2 Another video shows officials wearing masks, dressed in black and carrying large metal sticks chasing a man suspected of being infected with coronavirus through the largely deserted streets of the city as he runs away trying to escape from being put into one of the mass quarantine camps.

On Feb. 11, the Director-General of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus declared that China’s coronavirus outbreak poses 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.” 3

As of Feb.11, there had been 43,139 cases of novel coronavirus (2019-nCoV) confirmed globally. All but a few hundred cases had occurred in mainland China with a total of 1,018 reported deaths. 4

Similar to influenza, there has been an overall case fatality rate of between two and three percent so far for 2019-nCoV. Like with influenza, which the U.S. Centers for Disease Control (CDC) estimates is the cause of between 12,000 and 60,000 deaths in the U.S. every year, 5 and other respiratory diseases caused by viruses or bacteria, pneumonia is the most frequent and severe complication of novel coronavirus infection that leads to hospitalization and death. Those over age 50 with underlying chronic health conditions like heart disease or diabetes, especially men, are thought to be at greater risk for pneumonia complications of the novel coronavirus infection. 6

Whistleblower Doctor Dies in Hospital

According to the Feb. 6 New York Times article, the people of Wuhan were shaken by the police action following an “emotional gut punch” news report that a young doctor, who had been silenced for warning people late last year that there was an unusual coronavirus outbreak in the city, had died at the Wuhan City Central Hospital from the infection. CNN reported that the 34-year old opthalmologist, Li 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 is was accused of ‘spreading rumors online’ and ‘severely disrupting social order.’” 7

Dr. Wenliang became a hero figure in China and there are questions surrounding his death because he was threatened with punishment by the police and most coronavirus deaths have been senior citizens with underlying health conditions. 8 An unnamed senior advisor to the Chinese government reportedly told the Financial Times that, “In the current political atmosphere, which values obedience more than competence, local officials have an incentive to avoid taking responsibility.” 9 

The Feb. 6 New York Times article described the feeling of despair among residents in the city of 11 million this way:  

“With the sick being herded into makeshift quarantine camps, with minimal medical care, a growing sense of abandonment and fear has taken hold in Wuhan, fueling the sense that the city and surrounding province of Hubei are being sacrificed for the greater good of China.”

Hospitals Built, Quarantine Centers Created for Sick People

In the past four weeks, China has built several new hospitals and created makeshift medical treatment centers in a sports stadium, an exhibition center and building complex, in an attempt to house thousands of sick people. Reports from Wuhan suggest that there is a shortage of protective gear, as well as medical supplies to test and treat sick patients and that many Wuhan residents with respiratory symptoms are being left untested and untreated.

Outside observers are asking questions about whether the shelters are equipped with enough medical supplies and food or are staffed well enough to provide basic care to patients and prevent spread of not only coronavirus infections, but also a range of bacterial and viral diseases that can spread easily in crowded facilities. 10

China Censoring Information on Social Media Platforms

According to a Feb. 6, 2020 report by China Media Project, Chinese authorities have been censoring information published by news organizations and social media platforms criticizing the government’s response to the outbreak: 11

“A notice issued yesterday by the Cyberspace Administration of China, the central agency for control of the internet and social media, provides a glimpse not just of the actions being taken now by the authorities to control information about the coronavirus epidemic, but also of the platforms and activities that have threatened the Party’s dominance of information in recent days.

The notice, for example, singles out a number of WeChat public accounts alleged to have “illegally carried out reporting activities,” meaning that they are accused of acting journalistically, pursuing their own information on the epidemic. It orders the removal from app stores of “Pipi Gaoxiao,” a platform for the sharing of short videos, suggesting that material on the platform has “spread panic.”

On Feb. 7, Bloomberg News reported that two Chinese citizen journalists Chen Qiushi and Fang Bin “have served as the world’s eyes and ears inside the epicenter of the coronavirus outbreak” in Wuhan by broadcasting scenes real time via their cell phones. Many of their videos have been posted to Twitter and reposted on YouTube. 12

Fang was briefly detained by authorities for taking video of corpses in a hospital and for filming officials in hazmat suits breaking down his apartment door to take him into quarantine, but was released after thousands of public comments urging that he be set free. Chen, who had posted on Twitter that, “It’s easy to put 1,000 beds in a stadium, but how do 1000 people eat together? How to bathe, how to go to the toilet?” was first reported missing and then reported to have been arrested by authorities and put in quarantine. 13

Bloomberg News observed:

“China’s internet watchdog has stepped up its policing efforts, announcing on Wednesday it would conduct “targeted supervision” on the largest social media platforms including Weibo, Tencent’s WeChat and ByteDance’s Douyin. The regulator has already frozen a raft of social media accounts, then stepped up online scrubbing to quiet a wave of confused outrage over the death of the doctor that first raised red flags about the disease. In this environment, U.S.-based Twitter has emerged as the destination for locals seeking information about the spread of the virus. It’s officially banned in the country, but many people hop the Great Firewall and access the platform via virtual private networks.” 14

Cruise Ships Detained in Japan and Italy

Globally, the cruise line industry has been hard hit by quarantine measures taken by governments. Thousands of passengers and crews on big oceanliners are unable to disembark if someone on the boat tests positive for coronavirus.

CNN reported on Feb. 4 that some 6,000 passengers on a cruise ship in Italy were quarantined at the end of January after two guests were suspected of being infected but then tested negative for the Wuhan coronavirus. Japan ordered a lockdown and quarantine of more than 3,500 passengers and crew on the Diamond Princess cruise ship docked in Yokohama harbor after it was revealed an 80-year old man from Hong Kong flew to Tokyo and spent a few days on the ship and later tested positive for coronavirus. 15 Five days later, NBC reported that 70 passengers on ship had tested positive for coronavirus, including 14 Americans, and medication was being distributed on board to those who needed it, while some of the sick passengers have been taken to hospitals. The ship is expected to remain in quarantine until Feb. 19 and trained counselors are counseling passengers experiencing stress by telephone.  16

Daily Mail reported on Feb. 8 that Britain is considering a ban on travel into the country by foreign nationals who have visited China in the previous 14 days, a ban that has already been put in place by 16 countries, including the US, Australia, New Zealand and Japan. 17 A professor at the London School of Hygiene and Tropical Medicine was quoted as saying that modeling showed there are “ten times more cases of coronavirus infection than have been reported – or even more” because “It’s a mild disease that might be missed if somebody doesn’t seek healthcare. And none of the tests is going to be 100 percent sensitive so it is not unusual to only capture maybe 10 percent of the cases.”

U.S. Declares Public Health Emergency, Bans Entry of Foreign Nationals

On Jan. 31, 2020, the U.S. Secretary of Health and Human Services (HHS) Alex Azar held a press conference and declared a public health emergency in the U.S. due to the coronavirus epidemic in China. 18 He said U.S. citizens, who have been in China’s Hubei Province the previous 14 days will be subject to a 14-day mandatory quarantine prior to entering the U.S. In addition, the U.S. is temporarily suspending entry of most travelers who have recently been in China if they are not U.S. citizens. 19

According to National Public Radio (NPR), at the HHS press conference the Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, MD, said, “People want to know why we’re paying so much attention to the novel coronavirus.” He pointed to seasonal influenza, which Dr. Fauci said is predictable, but with the coronavirus “there are a lot of unknowns” and “the numbers of cases has steeply inclined each and every day.” Fauci added that at the beginning of the outbreak, it wasn’t clear whether an infected person without symptoms could transmit the virus to another person but it is now known there are “asymptomatic infections.” 20

At the same time, Bloomberg News reported that: 21

“The coronavirus has been compared to the flu, which every year infects 10 million to 50 million people in the U.S., leaving tens of thousands of people dead, according to the U.S. Centers for Disease Control and Prevention. It’s a mild-mannered serial killer. The aggressive response to the coronavirus is meant to stop the new pathogen from becoming a deadlier copycat.”

According to Bloomberg News, the Director of the Emergencies Programme of the World Health Organization (WHO) said, “A relatively mild virus can cause a lot of damage if a lot of people get it.”

U.S. Military Prepares Quarantine Centers

On Feb. 1, 2020, the Secretary of Defense (DOD) Mark Esper approved a request from the U.S. Department of Health and Human Services (HHS) for housing support at military bases for 1,000 people, including American citizens who arrive from other countries and could be subject to mandatory quarantine. Pentagon officials selected four military installations as quarantine centers, including in Fort Carson, Colorado; Travis Air Force Base and Marine Corps Air Station in California and Lackland Air Force Base in Texas. DOD personnel would only provide housing support and HHS would be responsible for all care and transportation of those being quarantined on military bases. 22

According to a Feb. 1 Reuters article, an anonymous source at the Department of Homeland Security (DHS) said that the mandatory quarantine is the first in more than half a century and that “state and local authorities will likely play a role with mandatory quarantines:” 23

“Since this hasn’t been done in 51 years there’s quite the scramble to work through all the procedures,” a Department of Homeland Security (DHS) official said, adding that the last mandatory quarantine was ordered to fight smallpox. The official, who requested anonymity because they are not authorized to speak publicly about the matter, said DHS personnel would take over running medical screenings at airports this weekend to free up their CDC counterparts for other tasks. State and local authorities will likely play a role with mandatory quarantines, the official said, which could mean “a lot of variance across the country for how it gets implemented.”

Other news outlets have reported that U.S. citizens returning from China on commercial flights may be re-routed to one of 11 airports that can perform extra health screenings, including in Los Angeles, Seattle, San Francisco, Atlanta, Honolulu, Dallas, Detroit, Newark, Washington Dulles, Chicago O’Hare and JFK Airport in New York City. 24

HHS Asks for Expanded Emergency Powers in 2016

The year after measles outbreaks were reported at Disneyland in 2015, HHS published a Notice of Proposed Rulemaking (NPRM) in the Aug. 15, 2016 Federal Register to amend the Public Health Service Act. The amendment gave federal government officials expanded police power to restrict the freedom of a person entering the U.S. or traveling between states if officials believe the person is infected or could become infected with certain kinds of diseases. 25

Until the 21st century, the list of contagious diseases permitting federal government officials to detain and involuntarily quarantine people was confined to a very serious contagious diseases with high mortality, including yellow fever, smallpox, cholera, diphtheria, infectious tuberculosis, and the plague. 26 Polio was never put on the list.

Between 2003 and 2014, HHS officials advised two Presidents to issue Executive Orders to expand the “isolate and quarantine” list. In 2003, Viral Hemorrhagic Fevers, such as Ebola, and Severe Acute Respiratory Syndrome or SARS were added. 27 In 2005, pandemic influenza was added. 28 In 2014, the Presidential Executive Order did not name a specific disease that would warrant detention and quarantine, it simply described “diseases associated with fever and signs and symptoms of pneumonia or other respiratory illness” that have “the potential to cause a pandemic” or are “highly likely to cause mortality or serious morbidity if not properly controlled.” 29

For More Information on Government Police Power to Quarantine

The National Vaccine Information Center (NVIC) provides information here about federal and state government police powers to enforce mandatory detention, isolation and quarantine of Americans who have or are suspected to have certain infectious diseases.

 

Part III - U.S. Marines and Navy Prepare to Execute Pandemic Plan as Questions Resurface about Coronavirus Origin as Questions Resurface about Coronavirus Origin

By Barbara Loe Fisher

Feb. 20, 2020: Responding to the coronavirus outbreak in China, where tens of thousands of citizens suspected of being infected with coronavirus (COVID-2019) have been detained and involuntarily taken to quarantine camps, 1 on Feb. 1, 2020 an executive order was issued by the U.S. Department of Defense (DoD), including the Joint Chiefs of Staff, directing the U.S. Northern Command to implement the DoD’s Global Campaign Plan for Pandemic and Infectious Diseases. 2 On Feb. 12, 2020, orders were sent to the U.S. Marine Corps 3 and Navy 4 directing “geographic combatant commanders to execute their pandemic plans in response to the NCOV outbreak.”

The U.S. Marine Corps directive told combat commanders to “review, update and validate existing disease containment plans and policies in order to implement procedures for response, isolation, quarantine, restriction of movement and community-based intervention” and to “become familiar with authority to declare a public health emergency, restrict movement, quarantine and isolate and coordinate with Federal, State, local, and military treatment facilities and public health emergency officials…” The U.S. Navy directive stated, “DoD will continue to follow CDC guidance and comply with local public health authorities during this outbreak.”

As of Feb. 18, 2020, there had been 75,198 cases of COVID-2019 detected globally and 2,009 deaths, with all but 1,013 cases and 5 deaths occurring in China. 5 The U.S. now has 29 confirmed cases being treated on military bases or in a biocontainment facility.

Reports by Chinese Scientists Raise Questions About Origin of Coronavirus

At the same time, over the past week new questions have resurfaced about whether the novel coronavirus (COVID-2019) can be traced back to scientific research conducted in Wuhan labs, a subject that has been widely discussed since January after the outbreak in China emerged. 6 According to a Feb. 16 report in the Daily Mail, scientists at the South China University of Technology have written a paper questioning whether research on bats and respiratory diseases at the Wuhan Institute of Virology and the Wuhan Centers for Disease Control (WCDC) 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. 7

On Feb. 15, a paper was published in The Lancet by Chinese scientists, “Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China.” The authors stated, “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 Jan. 2, 2020, of which 66 percent (27 people) had been exposed to the food market and 15 percent (6 people) died:

“Most of the infected patients were men (30 73% of 41); less than half had underlying diseases (13 32%), including diabetes (eight 20%), hypertension (six 15%), and cardiovascular disease (six 15%). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market...Complications included acute respiratory distress syndrome (12 29%), RNAaemia (six 15%), acute cardiac injury (five 12%) and secondary infection (four 10%). 13 (32%) patients were admitted to an ICU and six (15%) died.” 8

The World Health Organization (WHO) continues to maintain that the new virus spontaneously jumped from animals, most likely bats, to humans in the Wuhan market selling seafood and wildlife animals and that online speculation to the contrary is “misinformation.” In early February, International Business Times reported that WHO had teamed up with Google to battle online “misinformation” about the epidemic. 9 A Feb. 14 CNBC report revealed that the WHO hosted a meeting at Facebook’s Menlo Park, California campus with Google, Amazon, You Tube, Twitter, Verizon and other big tech companies to discuss how to “tamp down on misinformation about the coronavirus. 10

CDC Preparing for Novel Coronavirus to “gain a foothold in the U.S.”

According to the Atlanta Journal Constitution, on Feb. 12 Dr. Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, told media during a conference call “we can and should be prepared for this new virus to gain a foothold in the U.S.” 11

On Feb. 14, the U.S. Centers for Disease Control (CDC) announced that in Los Angeles, San Francisco, Seattle, Chicago and New York City, the agency had begun monitoring Americans with flu-like symptoms, who test negative for influenza, by additionally lab testing them for coronavirus. According to CNBC, the CDC intends to add more cities in the coming weeks in an effort to achieve a “national surveillance” system that would act as an early warning that COVID-2019 is spreading, which would “trigger a change in our response strategy,” said Messonnier. 12

A report by Reuters stated:

“The CDC's current strategy to fight the virus includes quarantines and travel restrictions, but that may change if the virus takes hold in the United States and begins to spread. In that scenario, the CDC will put in place "social distancing" strategies such as cancelling mass gatherings, using telemedicine, tele-schooling and remote working to try to disrupt the spread of the virus.” 13

Americans on Diamond Princess Cruise Ship Test Positive

More than 600 Americans, who were evacuated from Wuhan, China in early February, have been in quarantined in the U.S. and some have already been released. Other Americans suspected to have come in contact with COVID-2019 have been quarantined on cruise ships.  On Feb. 16, about 380 U.S. citizens on the Diamond Princess cruise ship quarantined in a Japanese harbor, who had not tested positive for coronavirus and were symptom-free, were offered seats on U.S. State Department chartered flights transporting them back to quarantine centers on military bases in California and Texas. According to CNBC, about 300 Americans accepted the State Department’s offer to fly back to the U.S., while nearly 100 others with no symptoms of illness decided to stay on the ship. 14

On Feb. 17, the U.S. State Department and Department of Health and Human Services issued a joint statement acknowledging that 14 asymptomatic American evacuees from the Diamond Princess cruise ship were allowed to fly on the chartered flights despite testing positive for coronavirus before getting on the planes. 15 According to USA Today, when the planes landed at military bases in Texas and California, 13 passengers who had tested positive for the virus were flown to the University of Nebraska Medical Center and Nebraska Medicine quarantine and biocontainment facility in Omaha for treatment. All of the Americans returning from the Diamond Princess will remain in quarantine for 14 days. 16

By Feb. 18, there had been 542 cases of COVID-2019 diagnosed among the cruise ships’ 3,700 passengers and crew. 17 Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told USA Today that, "The quarantine process failed." 18

Posse Comitatus Act of 1878

The scope of the mission of the U.S. Marines and U.S. Navy’s involvement in implementing the DoD’s Global Campaign Plan for Pandemic and Infectious Diseases in a civilian population is not clear as that Plan does not appear to have been publicly released by DoD. In general, however, the 1878 Posse Comitatus Act (PCA) prohibits the carte blanche use of military forces in civilian law enforcement in the U.S. 19

According to an essay for the Encyclopedia Brittanica: 20

"The willful use of the army or air force as a posse comitatus or otherwise to execute the laws is a felony, unless the use is expressly authorized by the Constitution or an act of Congress. The PCA directly applies only to the army and air force, without mentioning the navy, the Marine Corps, the Coast Guard, or the National Guard. The National Guard is subject to Article I, section 8 of the Constitution, "To provide for calling forth the Militia to execute the Laws of the Union, suppress Insurrections and repel Invasions." The National Guard is under state control until called into federal service, and is authorized to enforce the laws upon the request of a governor. Because the Coast Guard has a law enforcement function and is not under the control of the Department of Defense, it is not subject to the PCA. Although the naval service is not mentioned in the PCA, Department of Defense regulations extend the PCA to the navy and Marine Corps.”

Establishment of the U.S. Northern Command After 9/11  

After terrorist attacks on the U.S. mainland on Sept. 11, 2001 (9/11), the U.S. Northern Command was established Oct. 1, 2002. According to a 2008 report to Congress by the Congressional Research Service, “In 2002, President Bush signed a new Unified Command Plan (UCP) establishing United States Northern Command (NORTHCOM) to provide command and control of the Department of Defense’ (DOD’s) homeland defense efforts and coordinate military support to civil authorities.” 21

NORTHCOM’s area of responsibility includes the continental United States, Alaska, Canada, Mexico, and surrounding waters out to approximately 500 nautical miles, including the Gulf of Mexico and the Straits of Florida. Headquartered at Peterson Air Force Base in Colorado, the NORTHCOM Commander also commands North American Aerospace Defense Command. 22

U.S. Northern Command’s mission is to deter, prevent and defeat threats and aggression aimed at the United States, its territories, and interests. To this end personnel from the Army, Navy, Air Force, Marine Corps and Coast Guard are assigned to coordinate the protection of North America from external threats, drawing on the full capabilities of all U.S. military services, including the National Guard and Coast Guard, as necessary.  Additionally, the command is charged with providing defense support for civil authorities when approved by the President or Secretary of Defense. U.S. Northern Command (USNORTHCOM) also provides military resources and support to federal, state and local authorities.” 23

According to the USNORTHCOM website, so far it “has not had to respond to a large scale threat calling for military intervention” in U.S. territory. It has primarily been used to respond to natural or manmade disasters, such as hurricanes, floods, wildfires, earthquakes and a massive oil spill in the Gulf of Mexico, emphasizing that “the philosophy behind USNORTHCOM’s participation in defense support for civil authorities was to be prepared at all times but only to act when requested and to depart just as soon as their support was no longer required.” 24

The Feb. 12 DoD directives to the Navy and Marine Corps indicated that officials of U.S. Department of Health and Human Services (HHS) made the request to DoD and USNORTHCOM to get involved in anticipation of widespread coronavirus infections in the U.S. and that combatant commanders implementing DoD’s Global Campaign Plan for Pandemic and Infectious Diseases would be following directions from HHS and state and local public health officials.

Post 9/11 Model State Emergency Health Powers Act

After terrorist attacks on New York City and Washington, D.C. on September 11, 2001 (9/11), and subsequent reports of biological warfare threats against U.S. citizens, federal health officials immediately began preparing for mass anthrax and smallpox vaccination campaigns in the U.S. At the same time, model state legislation entitled the Model State Emergency Health Powers Act (MSEHPA) was introduced in multiple states to rewrite state public health laws and give federal and state public health officials sweeping new power over citizens when public health “emergencies” were declared by the Secretary of HHS and state governors.

The CDC had given Professor Lawrence Gostin, PhD, of the Center for Law and the Public’s Health at Georgetown and Johns Hopkins University, funding to develop the model legislation, which is why MSEHPA could be quickly introduced in the states the month after 9/11.25 Among its provisions, MSEHPA gave power to public health officials to:

  • take control of all roads leading into and out of cities and states; 
  • seize homes, cars, telephones, computers, food, fuel, clothing, firearms and alcoholic beverages for their own use (and not be held liable if these actions result in the destruction of  personal property); 
  • arrest, imprison and forcibly examine, vaccinate and medicate citizens without consent (and not be held liable if these actions result in death or injury).

The ACLU and other NGO’s defending civil liberties, 26 27 including the National Vaccine Information Center, 28 29 opposed the MSEHPA for giving too much power to government health officials to detain, isolate and force vaccination and other medical interventions on citizens without their voluntary informed consent. 30 The ACLU described the proposed model legislation as being “replete with civil liberties violations” and failing to “adequately protect citizens against the misuse of the tremendous powers that it would grant government health authorities in an emergency.” 31

In August 2002, Professor Gostin and his colleagues at Georgetown and Johns Hopkins Universities argued for compulsory quarantine and treatment of individuals in an article for the Journal of the American Medical Association: 32

Coercive powers are the most controversial aspects of any legal system… There similarly may be a need to exercise powers over individuals to avert a significant threat to the public’s health. Vaccination, testing, physical examination, treatment, isolation, and quarantine each may help contain the spread of infectious diseases. Although the vast majority of people probably will comply willingly (because it is in their interests and/or desirable for the common welfare), some compulsory powers are necessary for those who will not comply.”

In 2003, Gostin replied to critics of the MSEHPA, pointing out that “The U.S. Department of Health and Human Services (HHS) in Healthy People 2010, similarly argued that strong laws are a vital component of the public health infrastructure and recommended that states reform their outdated statutes.” He defended restraint of individual liberty in service to the public health: “When government acts to preserve the public's health, it can interfere with property rights (e.g., freedom of contract, to pursue a profession, or to conduct a business) or personal rights (e.g., autonomy, privacy, and liberty). The history of public health is littered with illustrations of trade offs between public health and civil liberties.” 33

Gostin questioned American values about “personal and proprietary freedoms” at the turn of the 21st century that opposed “substantial government presence in social and economic life,” and he expressed the opinion that 9/11 “reawakened the political community to the importance of public health:”

American values at the turn of the 21st century fairly could be characterized as individualistic. There was a distinct orientation toward personal and proprietary freedoms and against a substantial government presence in social and economic life. The attacks on the World Trade Center and Pentagon and the anthrax outbreaks reawakened the political community to the importance of public health. Historians will look back and ask whether September 11, 2001 was a fleeting scare with temporary solutions or whether it was a transforming event.”

 By 2011, 44 states had passed some form of the MSEHPA. 34

After 9/11 Congress Gave More Power to Executive Branch

After 9/11, immediately there were allegations that terrorists possessed weaponized smallpox and anthrax that could be used against the U.S. mainland population. Pressure was placed on Congress to create legislation to protect the American public from future bioterrorism attacks. Congress passed and President George W. Bush signed a series of new laws between 2002 and 2006 that gave expanded powers to the Executive Branch of the federal government and especially strengthened the authority of HHS during declared public health emergencies that involve disease control.

The Homeland Security Act of 2002 35 created the Department of Homeland Security (DHS), which assumed authority over existing federal agencies, including the U.S. Coast Guard, Federal Emergency Management Agency (FEMA), U.S. Immigration and Customs Service (ICE), U.S. Secret Service, Transportation Security Administration (TSA), among others. DHS works closely with HHS to respond to public health emergencies.

The National Vaccine Information Center opposed certain provisions in the Homeland Security Act of 2002. 36

The Project Bioshield Act of 2004 (“Bioshield 1”) 37 38 and Pandemic and All Hazards Preparedness Act of 2006 (“Bioshield 2”) 39 40 set up and funded a public-private financial partnership between private pharmaceutical companies and HHS to research and develop bioterrorism and pandemic vaccines for use by U.S. civilian populations. The 2006 Act amended the Public Health Service Act to require the Secretary of HHS to lead all federal public health and medical response to public health emergencies.

The National Vaccine Information Center opposed sections of the 2004 and 2006 Bioshield legislation, calling for responsible congressional oversight on expanded authority granted to federal public health officials by Congress after 9-11. 41 42

In the 2004 Bioshield Act, the U.S. Food and Drug Administration (FDA) was given an Emergency Use Authorization (EUA) 43 that allows experimental drugs and vaccines designated as medical countermeasures (MCM) to be fast tracked to licensure during a federally declared public health emergency. The Pandemic and All Hazards Preparedness Act of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) under HHS as the central point of authority within the federal government responsible for conducting advanced research to develop civilian medical countermeasures in collaboration with the pharmaceutical industry.

BARDA is shielded from Freedom of Information Act (FOIA) requests. Drug companies are shielded from liability if the drugs or vaccines developed for and used in HHS declared public health emergencies cause injury or death and so are persons forcing civilians to use the products. 44

In 2019, Congress passed The Pandemic and All-Hazards Preparedness and Advancing Innovation Act, strengthening the original 2006 Act. 45 This new law increased funding for HHS programs and BARDA research to develop genetically engineered vaccines to respond to emerging pandemics and antimicrobial resistance.46

In addition, the government’s official “isolate and quarantine” list was expanded between 2003 and 2014 to include Viral Hemorrhagic Fevers, such as Ebola, and Severe Acute Respiratory Syndrome (SARS), 47 adding pandemic influenza in 2005.48 In 2014, the Presidential Executive Order did not name a specific disease that would warrant detention and quarantine, it simply described “diseases associated with fever and signs and symptoms of pneumonia or other respiratory illness” that have “the potential to cause a pandemic” or are “highly likely to cause mortality or serious morbidity if not properly controlled.” 49

In 2016, using rule making authority to amend the Public Health Service Act, HHS expanded their police powers to apprehend individuals or their minor children entering the U.S. or traveling across state borders by airplane, ship, bus or train, and isolate or involuntarily quarantine them if they have minor symptoms of illness that could indicate “they are or may become infected with quarantinable infectious diseases.” 50 In a public comment to HHS, the National Vaccine Information Center opposed sections of the proposed amendment giving HHR more power to detain, involuntarily quarantine and compel individuals to submit to vaccination as condition for release: 51

“Health officials in the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), have more than enough authority under the U.S. Constitution and the Public Health Service Act to prevent the introduction, transmission and spread of a short list of serious communicable diseases with very high mortality rates, such as hemorrhagic fevers. However, this NPRM makes a point of equating non-quarantinable vaccine-targeted diseases, such as measles and chickenpox, with quarantinable diseases, such as tuberculosis and smallpox. It expands the list of minor illness symptoms that could trigger the use of police power by government health officials to apprehend and involuntarily quarantine individuals, who can be asked to consent to vaccination as a condition of release from government custody.”

Microsoft News: Coronavirus Vaccine Will Eliminate Need for Quarantines

On Feb. 6, the Bill and Melinda Gates Foundation announced that it is pledging up to $100 million to combat coronavirus and “help find a vaccine for the virus, limit its spread and improve detection and treatment of patients.” Immediately, $20 million will go to the U.S. Centers for Disease Control and World Health Organization. 52  Since the Gates Foundation was established in 2000, with a primary goal of funding global public health initiatives, more than $3 billion has been given to fund global vaccination programs. 53

Microsoft News, which is owned by Microsoft, a corporation co-founded by Bill Gates, stated that a coronavirus vaccine would end quarantines:

“First appearing late December of 2019, the new coronavirus (called the COVID-19) managed to kill almost 1,400 people and infect several thousands more in Mainland China alone in a mere two months, putting people to pin their hopes on one of the most effective disease-fighting tools: a vaccine. Having one would mean that there would no longer be a need to quarantine people nor close off cities and monitor airports because people would be protected from the virus even before they get exposed.”  54

 

Part IV - Unprecedented Response to COVID-19 by Governments Prohibits Physical Contact and Cripples World Economy

by Barbara Loe Fisher

Mar. 29, 2020: After officials at the World Health Organization (WHO) declared on Mar. 11, 2020 that outbreaks of a mutated coronavirus (COVID-2019) 1 2 had become a global pandemic and urged countries to take strong action to stop its spread,3 4 the governments of countries representing one-third of the world’s population 5 closed borders, restricted or halted travel between and within countries and ordered healthy people to essentially 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 6 and has crippled the world’s economy. 7

Testing Not Widespread Yet to Detect Asymptomatic and Symptomatic Cases

The outbreak of a new mutated coronavirus in China was publicly announced on Dec. 31, 2019, 8 and by Mar. 27, 2020, over 565,000 people in 199 countries reportedly had been infected with over 25,000 confirmed deaths. 9

The true number of cases that have already occurred are thought to be vastly underestimated because an unknown number of people are being asymptomatically infected or showing only mild symptoms, 10 11 12 which can be mistaken for a cold or a respiratory influenza-like-illness, 13 and testing for COVID-19 active infection or antibodies demonstrating past infection and natural immunity has not yet become widespread in most countries. 14 15

In the U.S., since Jan. 21, 2020 more than 90,000 cases and 1,300 deaths had been confirmed spanning all 50 states. 16 By Mar. 27, New York had reported the highest numbers of cases (38,987) and deaths (432) to date, with New Jersey, California, Washington, Michigan, Illinois, Florida, Massachusetts and Louisiana reporting between 2,000 and 7,000 cases each and a total of 539 deaths. 17

Current Mortality Estimates Vary Among Countries

According to Worldometer, 18 which is owned by Dadax and composed of an international team of developers, researchers and volunteers with no political, government or corporate affiliation analyzing and making world statistics available to the public, there is a large variation in mortality estimates associated with COVID-19 at the present time. For example, as of Mar. 27, China appears to have 2 deaths per million people, while Germany and the U.S. currently are experiencing 4 deaths per million, but Italy has 151 deaths per million and Spain has 106 deaths per million.

For all currently reported global cases and deaths, it appears there is an average of 3.4 deaths per million people.19  However, with more widespread testing for and reporting of active and past infections, along with deaths, these preliminary COVID-19 mortality statistics for different countries could change. 20

COVID-19 Complications Higher in Seniors and Chronically Ill

By mid-February, there was information coming out of China that some people were at higher risk for complications from COVID-19 infections than others, even though the majority of people have mild symptoms and recover without treatment. 21 The World Health Organization (WHO) states that: 22

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Most 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 high risk factors 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.23 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.”  24

As of Mar. 27, 2020, the CDC currently lists the following high risk factors for severe illness from a COVID-19 infection: 25

  • People aged 65 years and older
  • People who live in a nursing home or long-term care facility
  • Other high-risk conditions could include:
    • People with chronic lung disease or moderate to severe asthma
    • People who have heart disease with complications
    • People who are immunocompromised including cancer treatment
    • People of any age with severe obesity (body mass index (BMI)≥40) or certain underlying medical conditions, particularly if not well controlled, such as those with diabetes, renal failure, or liver disease might also be at risk
  • People who are pregnant should be monitored since they are known to be at risk with severe viral illness, however, to date data on COVID-19 has not shown increased risk

The CDC also says that the following symptoms are found in patients who have been tested and confirmed to be infected with COVID-19: 26

“Frequently reported signs and symptoms of patients admitted to the hospital include fever (77–98%), cough (46%–82%), myalgia or fatigue (11–52%), and shortness of breath (3-31%) at illness onset. Among 1,099 hospitalized COVID-19 patients, fever was present in 44% at hospital admission, and developed in 89% during hospitalization. Other less commonly reported respiratory symptoms include sore throat, headache, cough with sputum production and/or hemoptysis coughing up blood or bloody mucus. Some patients have experienced gastrointestinal symptoms such as diarrhea and nausea prior to developing fever and lower respiratory tract signs and symptoms.”

According to the CDC, “Based on available evidence, children do not appear to be at higher risk for COVID-19 than adults. While some children and infants have been sick with COVID-19, adults make up most of the known cases to date.” 27

Americans Start Buying Masks and Hand Sanitizer to Protect Themselves

By the end of February, the World Health Organization (WHO) had not yet declared COVID-19 to be a pandemic, 28 but there had been daily reports in the media warning that COVID-19 was taking a foothold in the U.S. 29 and many concerned Americans had begun to make preparations to protect themselves by buying masks, hand sanitizer and stocking food and household supplies. On Mar. 1, the U.S. Surgeon General Dr. Jerome Adams sent out a message on Twitter: 30

“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.”

CDC Director Dr. Robert Redfield agreed. He told 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.” 31

CDC Predicted Up To 1.7 Million COVID-19 Deaths in the U.S.

Two days after the WHO declared a COVID19 pandemic, the New York Times published a widely-quoted article on Mar. 13 entitled “The worst-case estimate for U.S. coronavirus deaths” that raised even more concern in the public about the potential lethality of COVID-19. 32 In the article, it was revealed that the U.S. Centers for Disease Control and Prevention (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 coronavirus to come up with “worst case” estimates if no actions were taken to slow transmission.

According to the New York Times:

“Between 160 million and 214 million people in the U.S. could be infected over the course of the epidemic, according to one projection. That could last months or even over a year, with infections concentrated in shorter periods, staggered across time in different communities, experts said. As many as 200,000 to 1.7 million people could die. The calculations based on the CDC’s scenarios suggested 2.4 million to 21 million people in the U.S. could require hospitalization, potentially crushing the nation’s medical system, which has only about 925,000 staffed hospital beds. Fewer than a tenth of those are for people who are critically ill.”

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 said “changing behavior” would alter the course of the pandemic. A University of Nebraska infectious disease specialist, Dr. James Lawler, was quoted as estimating there would be 96 million Americans infected and 450,000 deaths.  

The New York Times article also pointed out that, “about 20,000 to 50,000 people have died from flu-related illnesses this season, according to the CDC.”  

WHO Urges Testing But U.S. Couldn’t Do It For Months - Fauci Tells Americans to “Hunker Down”

Several days later on Mar. 16, WHO Director-General Tedros Ghebreyesus criticized nations for not doing enough to test for and contain spread of COVID-19. He said: 33

 We have not seen an urgent enough escalation in testing, isolation and contact tracing, which is the backbone of the response...We have a simple message for all countries: Test, test, test. Test every suspected case. If they test positive, isolate them and find out who they have been in contact with two days before they developed symptoms and test those people, too.”

A week later Dr. Ghebreyesus said, “Asking people to stay at home and other physical distancing measures are an important way to slow down the spread of the virus and buy time, but they are defensive measures that won’t help us to win.” 34  He once again emphasized widespread testing for COVID-19. “All countries should be able to test all suspected cases. They cannot fight this pandemic blindfolded; they should know where the cases are.” 

However, by the time COVID-19 was first reported in the U.S. on Jan. 21, 2020 until just recently, little testing for presence of the virus in the U.S. population was done. 35 Instead, former and current federal health officials have put primary emphasis on shutting down education, commerce, business and recreation to try to stop spread of the virus.

Former FDA Commissioner Dr. Scott Gottlieb told CBS’s “Face the Nation” on Mar. 8 that, "No city wants to be the first to basically shut down their economy, state and cities are going to have to act in the interest of the national interest," 36 and urged the federal government to provide economic incentives to cities and states that will suffer hardship from shutting down their economies.

On Mar. 12 at a congressional hearing, 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 coronavirus testing of everyone in the U.S. who needs it. "The system is not really geared to what we need right now," he said. “That is a failing. Let’s admit it.” 37

A few days later, Dr. Fauci advocated for taking aggressive quarantine and “social distancing” measures in the U.S. similar to those first taken by the Chinese and, later, the Italian government to “lockdown” populations in an effort to stop spread of COVID-19. On Mar. 15, Dr. Fauci said on NBC’s “Meet the Press: 38

“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.”

Persistent COVID-2019 Testing Problems in the U.S.

On Mar. 22, 2020, the FDA approved a 45-minute lab test to confirm COVID-2019 infections.  39 The approval came after a series of investigative reports had been published by Science Magazine, Pro-Publica, and Axios that the U.S. had been suffering from continuing problems with providing COVID-19 testing kits to hospitals in the states after the COVID-19 outbreak was identified in the U.S. in January 2020.

On Feb. 28, Science Magazine reported the CDC had only performed 459 tests for the virus in patients suspected to be infected: 40

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the country eager to test more suspected cases—and test them faster—have been unable to do so. No commercial or state labs have the approval to use their own tests.

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern California who turned out to be the first probable COVID19 case without known links to an infected person. The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is accurate.”

Also on Feb. 28 Pro-Publica reported: 41

“As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test. The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn’t work as expected.”

On Mar. 1, Axios said that the Trump administration had ordered an independent investigation of the Centers for Disease Control and Prevention lab in Atlanta responsible for manufacturing COVID-19 test kits for labs around the country after reports of potential contamination of the test kits. Axios stated that, “The U.S. government had admitted to problems with its diagnostic tests — which have put the U.S. well behind China and South Korea in doing large-scale testing of the American public for the coronavirus.” 42

According to the Mar. 27 report by USA Today: 43

“From its biggest cities to its smallest towns, America’s chance to contain the coronavirus crisis came and went in the seven weeks since U.S. health officials botched the testing rollout and then misled scientists in state laboratories about this critical early failure. Federal regulators failed to recognize the spiraling disaster and were slow to relax the rules that prevented labs and major hospitals from advancing a backup…the nation’s public health pillars — the Centers for Disease Control and Prevention and the Food and Drug Administration — shirked their responsibility to protect Americans in an emergency like this new coronavirus, USA TODAY found in interviews with dozens of scientists, public health experts and community leaders, as well as email communications between laboratories and hospitals across the country. The result was a cascading series of failures now costing lives.”

Federal Agencies Fail to Stockpile Adequate Pandemic Supplies

Federal agencies responsible for pandemic planning, notably the U.S. Department of Health and Human Services (DHHS) 44 45 46 and Department of Homeland Security (DHS), 47 which are given billions of dollars in congressional appropriations every year, 48 49 appear to have been unprepared to respond quickly to the COVID-19 pandemic not only by failing to supply testing kits but because they had not stockpiled enough masks, gowns and gloves needed for health care workers and ventilators needed for patients.  50

Healthcare workers at hospitals are reporting they do not feel safe treating patients with COVID-19 when they do not have appropriate protective equipment that protects both them and their patients. In a Mar. 26 International Business Times article, a nurse working for Kaiser Permanente was quoted as saying, “They're putting us in danger. They're putting our families in danger, and they're putting our co-workers in danger.” 51

In a report by NBC surveying more than 250 health care workers in the U.S., the network reported that: 52

 “A hospital nurse in Michigan says she and her colleagues have discussed bringing in bleach to make their own disinfectant wipes. A pregnant nurse in Ohio says she has no choice but to tend to critically ill patients without a specialized N95 mask. And a health care worker in Georgia has resorted to scouring local hardware stores in an effort to secure the protective masks…Nearly all who responded said there were shortages of PPE personal protective equipment in the hospitals, outpatient clinics and offices where they worked. Many reported being forced to ration or reuse supplies, including surgical and N95 masks, for fear of running out. Many also said they were facing shortages of basic sanitary supplies, including hand sanitizer and disinfectant wipes.”

Americans Endure Financial Hardship, Loss of Civil Liberties

With at least half the country in some kind of “lockdown” that requires Americans to lose their income and their freedom in order to comply with federal quarantine guidelines and state quarantine laws, following is a selection of media reports about what they are being told to endure during the COVID-19 public health emergency:

Jail Time for Quarantine Breakers. On Mar. 13, an Austin, Texas station reported that 53 the Austin-Travis County Health Authority is taking legal action against those ordered to quarantine in their homes and anyone breaking quarantine could get up to 6 months in jail. If the Health Authority believes someone “is ill with, has been exposed to, or is the carrier of” COVID-19, the order also prohibits the person from having people over to their home “without the prior approval of Austin Public Health.” People under quarantine cannot “congregate in settings such as grocery stores, movie theaters, etc,” and must record their own temperatures and give that information to the Health Authority in phone calls conducted up to two times each day during quarantine, which usually lasts14 days.

Quarantine Shaming. On Mar. 19, Associated Press reported that many Americans were being subjected to criticism and shunning if they choose not to or cannot strictly conform with recently enacted “social distancing” rules: 54

“Quarantine shaming” — calling out those not abiding by social distancing rules — is part of a new and startling reality for Americans who must navigate a world of rapidly evolving social norms in the age of COVID-19. As schools close and shelter-in-place orders sweep across the U.S., the divide between those who are stringently practicing self-isolation and those who are still trying to go about some semblance of a normal life has never been more clear. Complicating matters: What was socially acceptable even 48 hours ago may now be taboo, as government officials race to contain the virus with ever-expanding circles of social isolation.”

Scolding the Public. After cancelling the St. Patrick’s Day Parade, which has been held every year since 1772, on Sunday Mar. 22, New York Governor Andrew Cuomo and New York City Mayor Bill de Blasio scolded New York City residents for going to parks. According to Associated Press, Governor Cuomo said he was “exasperated” that people are ignoring his social distancing orders and are clustering in groups and acting like it was just another nice spring weekend.” 55 Governor Cuomo was quoted as saying:

“There is a density level in New York City that is wholly inappropriate. This is just a mistake! It is a mistake! It is insensitive. It is arrogant. It is self-destructive. It’s disrespectful to other people and it has to stop and it has to stop now. This is not a joke and I am not kidding.”

You Are Your Safest Sex Partner. According to an article in Newsweek, 56 the day before on Mar. 21, the New York City Health Department issued guidance for residents of New York City about how to have safe sex during the coronavirus outbreak.  Advising residents to stay home and minimize contact with others, the fact sheet posted on the health department’s website stated “you are your safest sex partner” because it “will not spread COVID-19, especially if you wash your hands (and any sex toys) with soap and water for at least 20 seconds before and after sex.” The Health Department also instructed people to “disinfect keyboards and touch screens that you share with others (for video chat, for watching pornography or for anything else).” 57

Temperature Taking Before Entering Supermarkets? On Mar. 22, Dr. Anthony Fauci told Science Magazine that requiring Americans to have their temperatures taken before they enter a supermarket like was done in China is “something that should be considered.” He added, “I will bring it up at the next task force meeting and see whether there’s some sort of a logistical, bureaucratic reason why it can’t be done. The rationale for doing it is at least worth serious consideration.” 58

Using Drones to Drive People Indoors. On Mar. 23, International Business Insider said that, "law enforcement in California is using drones to make sure that people do not flout quarantine measures amid a lockdown in the state.” 59 After the Governor of California declared a state of emergency and told residents they had to stay in their homes and only leave to buy essential supplies and medicine, police in a city near San Diego (Chula Vista) purchased two $11,000 drones with speakers and night vision cameras “to drive people indoors” during the lockdown.

China was the first country to use drones to reprimand citizens who didn’t obey COVID-2019 quarantine rules and then France and Spain began using drones to warn people to return to their homes. 60 Some nations, like India, have taken harsher measures. The government has warned the population of over 1.3 billion people that anyone defying the coronavirus lockdown order could be shot. 61

Banning Partners and Doulas at Births in Hospitals. On Mar. 24, The Hill reported that: 62

“Expectant mothers planning to give birth at two leading New York City hospital systems will not be able to have spouses, partners, midwives or doulas present, despite a mother’s birth plan. Hospital networks NewYork-Presbyterian and Mt. Sinai Health have limited their visitor policies to ban family members, spouses and birth coaches from delivery rooms in an effort to further reduce the spread of the coronavirus in medical settings.”

124,000 US Public and Private Schools Closed. On Mar. 27, Education Week reported that “School closures due to coronavirus have impacted at least 124,000 U.S. public and private schools and affected at least 55.1 million students.” Schools are closed in all 50 states currently. In California, New Jersey and North Dakota, schools are closed until further notice. The states of Kansas, Virginia, Oklahoma, Alabama, Vermont, Nebraska and New Mexico have announced schools will not open again this school year. 63

“Do Not Resuscitate” the Infected?

On Mar. 26, the Washington Post reported that hospitals are debating “how to weigh the ‘save at all costs’ approach to resuscitating a dying patient against the real danger of exposing doctors and nurses to the contagion of coronavirus.” The discussion is being driven by the nationwide shortage of personal protective equipment – such as masks, gowns and gloves – and questions being raised about whether it is worth the risk to hospital staff to “justify the conventional response when a patient ‘codes,’ and their heart or breathing stops.”

According to the Washington Post: 64

“Northwestern Memorial Hospital in Chicago has been discussing a universal do-not-resuscitate policy for infected patients, regardless of the wishes of the patient or their family members — a wrenching decision to prioritise the lives of the many over the oneOfficials at George Washington University Hospital in Washington say they have had similar conversations, but for now will continue to resuscitate Covid-19 patients using modified procedures, such as putting plastic sheeting over the patient to create a barrier. The University of Washington Medical Centre in Seattle, one of the country’s major hot spots for infections, is dealing with the problem by severely limiting the number of responders to a contagious patient in cardiac or respiratory arrest.

Earlier in March, The Atlantic reported that doctors in Italy had begun employing a utilitarian rationale to justify denying medical care to elderly COVID-2019 infected patients or those with underlying conditions that raised their risk for death. 65 The Italian College of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) published guidelines for the criteria that doctors and nurses should follow, comparing “the moral choices Italian doctors may face to the forms of wartime triage and, rather than providing intensive care to all patients who need it, instead apply “distributive justice and the appropriate allocation of limited health resources.”

The approach that is being taken in Italy is based on utilitarianism, which uses a mathematical model as a guide to public policy that justifies sacrificing the few in order to maximize benefits for a greater number of people. When making intensive care decisions, the doctors would follow criteria that guarantees only patients with “the highest chance of therapeutic success will retain access to intensive care” and the rules would apply to all patients, not only those infected with coronavirus. They have discussed that “it may become necessary to establish an age limit for access to intensive care.”

 “Those who are too old to have a high likelihood of recovery, or who have too low a number of ‘life-years’ left even if they should survive, would be left to die.”

Deliberately Infect Vaccine Trial Participants with COVID-19?

In another unprecedented development regarding medical ethics, on Mar. 25, MIT Technology Review reported that, “A group of academics say that 100 altruistic young people should volunteer to get a vaccine for Covid-19 and then be infected with the coronavirus on purpose.” 66 The academics admit that a “challenge trial” is controversial but argue it could speed up testing of a vaccine to prove it does or does not work.

According to MIT Technology Review:

“No one, though, has yet had virus squirted up their nose on purpose, something that is ethically dubious under most circumstances. The drawback is obvious, the authors admit: “Challenging volunteers with this live virus risks inducing severe disease and possibly even death.”

“It’s likely that if a challenge trial occurs, plenty of volunteers would sign up. After all, first responders, EMTs, health-care workers, and even grocery store clerks are already putting themselves at risk of Covid-19 by staying on the job. It may seem impermissible to ask people to take on risk of severe illness or death, even for an important collective gain,” the authors of the challenge proposal write. “But we actually ask people to take such risks for others’ direct gain every time we ask volunteer firefighters to rush into burning buildings.”

 

Part V - COVID-19 Meltdown & Pharma’s Big Money Win

Apr. 1, 2020: Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases (NIAID) told Americans on Apr. 1, 2020 that modeling reports suggested COVID-19 infections could eventually “kill 100,000 to 240,000 Americans,” 1 2 3 which was considerably less than the worst case 1.7 million mortality figure the Centers for Disease Control (CDC) talked about on Mar. 13, 4 and a fraction of the doomsday 2.2 million mortality figure projected by a scientist at Imperial College London. 5 6 The next day, Fauci called for an all-state nationwide lockdown 7 and CDC officials instructed Americans to cover their faces with cloth masks if they have to leave their homes to buy food or seek medical care. 8

On Apr. 6, University of Washington modeling experts, who influenced the setting of current federal and state “social distancing” policies, lowered U.S. COVID-19 mortality estimates from the worst case 162,000 fatalities they predicted on Mar. 26 to about 82,000 deaths. 9 10 Two days later, on Apr. 8, they lowered U.S. mortality estimates even further to 60,415 deaths by Aug. 4, but included the caveat “assuming full social distancing through May 2020.” 11

With the U.S. economy in meltdown, this week, Dr. Fauci warned that, until a COVID-19 vaccine is available, we have to prepare for a new normal. He said: 12

“If back to normal means acting like there never was a coronavirus problem, I don’t think that is going to happen until we have a situation where you can completely protect the population.

“If you want to get to pre-coronavirus, that might never happen in the sense of the fact that the threat is there,” but I believe with the therapies that will be coming online and the fact that I feel confident that over a period of time, we will get a good vaccine, we will never have to get back to where we are right now.”

COVID-19 Deaths by the Numbers

By Apr. 10, 2020, there had been more than 18,000 COVID-19 related deaths reported in the U.S. population of 325 million people and over 100,000 deaths in a global population of 7.8 billion people. 13  According to the CDC, most cases are asymptomatic or mild, including in children, 14 unless an individual has an underlying chronic health problem like asthma, obesity, diabetes, autoimmunity, immune suppression, high blood pressure, chronic obstructive pulmonary disease (COPD) or heart disease. 15 16 17 18

There are large mortality variations among different countries and similar wide variations in mortality among populations living in different states in the U.S. 19 At least one study published on Apr. 5 has found that air pollution subjecting individuals to long term exposure to fine matter particulates greatly increases the risk for death from COVID-19, noting 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.” 20

“A small increase in long-term exposure to PM2.5 fine particulate matter leads to a large increase in COVID-19 death rate, with the magnitude of increase 20 times that observed for PM2.5 and all-cause mortality. The study results underscore the importance of continuing to enforce existing air pollution regulations to protect human health both during and after the COVID-19 crisis.”

A Mar. 30 report in The Lancet estimated the overall case fatality ratio in China has been 1.38 percent, but is substantially higher in those over 60 years old. 21 Recent published data from the CDC also confirms that mortality in the U.S. is much higher among senior citizens over age 65, rising to 10 to 27 percent for those over age 85.  22 The CDC continues to state that individuals at higher risk for serious illness from COVID-19 infection are those over age 65 and “people of all ages with underlying medical conditions, particularly if not well controlled.” 23

U.S. COVID-19 Mortality Statistics: Science or Assumptions?

On Mar. 24, the Director of Division of Vital Statistics, National Center for Health Statistics (NCHS) operated by the CDC issued a COVID-19 memo Alert with Q&A instructions informing doctors and coroners that “a newly-introduced ICD code UO7.1 COVID-19 has been implemented to accurately capture mortality data for Coronavirus Disease 2019 (COVID-19) on death certificates.” When determining the underlying cause of death listed on the death certificate, the memo states that:

“The underlying cause of death depends upon what and where conditions are reported on the death certificate.  However the rules for coding and selection of the underlying cause of death are expected to result in COVID-19 being the underlying cause more often than not.”

CDC officials make it clear that on cases where the death certificate indicates uncertainty about the cause of death, there likely be no follow up and the death will be listed as COVID-19:

“If a death certificate reports terms such as “probable COVID-19” or “likely COVID-19,” these terms would be assigned the new ICD code UO7.1 COVID-19. It is not likely that NCHS will follow up on these cases.”

Finally, answering the question, “Should COVID-19” be reported on the death certificate only with a confirmed test?” the CDC’s memo emphasizes that lab confirmation of COVID-19 is unnecessary to list the cause of death as COVID-19 on the death certificate:

“COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death.boldfaced text was boldfaced in the CDC’s Alert.

In an Apr. 9 NBC “Today Show” interview, Dr. Fauci was asked whether some deaths are being falsely counted as COVID-19 deaths when they are really due to other causes. He replied: 24

“There’s absolutely no evidence that that’s the case at all. I think it falls under the category of something that’s been unfortunate – conspiracy theories that we hear about every time we have a crisis of any sort. There’s always this popping up of conspiracy theories. I think the deaths that we’re seeing are coronavirus deaths and the other deaths are not being counted as coronavirus deaths…I think there’s more of a chance of missing some that are really coronavirus deaths not being counted."

Economic and Social Meltdown Continues

More than two months after the World Health Organization (WHO) declared the outbreak of COVID-19 in China as a “Public Health Emergency of International Concern,” 25 which was followed the next day by the CDC’s Jan. 31 declaration of a national Public Health Emergency in the U.S., 26 it appears that the government’s pandemic planning efforts spanning four decades failed to prepare federal and state health agencies to respond quickly, 27 28 29 30 31 despite federal legislation 32 that ensured substantial annual congressional appropriations to the U.S. Department of Health and Human Services (DHHS) since 2006 for pandemic planning. 33 34 Right now, COVID-19 testing kits are slowly rolling into the states but in limited quantities, 35 36 and health care workers are continuing to report critical shortages of personal protective equipment (PPE) and medical supplies. 37 38 39

With almost every state government following federal guidelines and either requesting or ordering residents to quarantine themselves at home – whether they are healthy or sick - families are facing unprecedented economic losses. 40 On Apr. 3, the U.S. Bureau of Labor Statistics (BLS) reported huge declines in employment in the leisure and hospitality industries – mainly in food and beverage – but also in healthcare, social assistance, professional and business services, retail trade, and construction. 41 Unemployment in the U.S. rose by almost a full percentage point to 4.4 percent, the largest over-the-month rate increase since 1975, with the number of unemployed persons rising from 1.4 million to 7.1 million in March. The BLS report said the sharp unemployment increases reflects the “efforts to contain” the coronavirus in the U.S.

Lower income families without savings and dependent upon hourly wages and part-time work in service professions are hit especially hard. 42 Understaffed social service support systems are struggling to cope with significant increases in depression, spousal and child abuse, and calls to suicide hotlines. 43 44 45  

However, some scientists, 46 47 doctors 48 and politicians 49 want quarantines to stay in effect beyond April 31, even though the managing director of the International Monetary Fund Kristalina Georgieva warned on Apr. 9 that the economic fallout of shutdowns is approaching that of the Great Depression.  50

We are still faced with extraordinary uncertainty about the depth and duration of this crisis. It is already clear, however, that global growth will turn sharply negative in 2020, as you will see in our World Economic Outlook next week. In fact, we anticipate the worst economic fallout since the Great Depression.”

Bill Gates Calls for 10 Week Nationwide Shutdown and Certificates of Immunity Allowing Unrestricted Movement

In an OpEd in the Mar. 31 Washington Post, Microsoft founder and philanthropist social reformer Bill Gates called for a nationwide federally enforced quarantine for all states that would last “10 weeks or more:

“Because people can travel freely across state lines, so can the virus. The country’s leaders need to be clear: Shutdown anywhere means shutdown everywhere. Until the case numbers start to go down across America — which could take 10 weeks or more — no one can continue business as usual or relax the shutdown.” 51 52

Several days earlier in a TED interview, Gates talked about how the strict social distancing and quarantine measures in place in the U.S. are designed to prevent a majority of the U.S. population from being infected with and recovering from COVID-19, which confers natural immunity and contributes to herd immunity in human populations. He also stated there will be a need for people to have “certificates” that prove they have either recovered from the infection or have been vaccinated once a vaccine is produced. He said: 53

“Now we don’t want to have a lot of recovered people, you know. To be clear, we’re trying through the shutdown in the United States, to not get to one percent of the population infected. We’re well below that today, but with expotentiation you could get past that three million. I believe we will be able to avoid that with having this economic pain.

“Eventually, what we’ll have to have is certificates of who is a recovered person, who’s a vaccinated person, because you don’t want people moving around the world where you’ll have some countries that won’t have it under control, sadly. You don’t want to completely block off the ability for people to go there and come back and move around.”

Fauci Agrees with Gates: COVID-19 Natural Herd Immunity Not Wanted

At a Apr. 6, White House briefing of the Coronavirus Task Force, Dr. Fauci confirmed that strict social distancing and quarantine measures are at least partially in place to prevent populations from developing natural herd immunity. He said: 54

“One issue that’s going to be important and it has to do with somewhat of a comparison, for example, with influenza. We go through multiple cycles of influenza and there’s always a degree of background immunity in a population. That will ultimately happen with COVID-19 if we get a situation where we get back to normal. Now, I hope we don’t have so many people infected that we actually have that herd immunity, but I think it would have to be different than it is right now.”

In an Apr. 9 interview on National Public Radio (NPR), Bill Gates returned to the message that some “social distancing” measures have to stay in place “until we get a vaccine that almost everybody’s had.” He said:

"What I'm saying, what Dr. Anthony Fauci is saying, what some other experts are saying, there's a great deal of consistency. We're not sure yet which activities should be resumed, because until we get a vaccine that almost everybody's had, the risk of a rebound will be there. ... As we follow the numbers into May and see if we can get them down to a very low level, then in parallel, this debate about which things have benefits to society and can be formatted so the infection risk is very low, which things should we resume? I do think manufacturing, construction, a lot of things we'll do, but large public gatherings may have to wait until we have that vaccine.”

Governments Make Fast Tracked COVID-19 Vaccines Main Priority

Immediately after the Jan. 30 WHO declaration that a novel coronavirus outbreak in China posed a “public health emergency of international concern,” press releases were issued by the Gates Foundation 55 and World Health Organization (WHO) 56 informing the world that experimental coronavirus vaccines already in development would be put on a fast track to licensure for global use.

On Mar. 9, WHO released its COVID-19 R&D roadmap that, according to BioWorld, had been endorsed by “400 experts” and included funding from the European Commission (37.5 million euros), German government (10 million euros) and an additional 46 million euros from the UK government, with 20 million euros going directly to the Coalition for Epidemic Preparedness (CEPI) for vaccine development. CEPI committed $100 million to speed up licensure of COVID-19 vaccines but said it was trying to raise $2B more to speed vaccines to market. 57

The WHO’s R&D plan stated there was an “urgent need” to fill in scientific knowledge gaps about the “basic biology” of COVID-19 infection and clinical evolution of COID-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. The WHO roadmap stated, “Evaluating the potential for enhanced disease in humans is critical before vaccines can be assessed through larger-scale studies.” 58

By mid-March and early April, the WHO, National Institutes of Health, 59 universities, 60 and global pharmaceutical corporations 61 had announced development of more than 50 experimental COVID-19 vaccines. 62 63  Using vitamin and supplement therapies or currently licensed prescription drugs 64 65 66 67 68 69 has taken a back seat to an aggressive push to keep restrictive “social distancing” measures in place until fast tracked experimental vaccines are licensed. 70 71 72  

Maintaining that the only solution to dealing with the new coronavirus is universal use of a new vaccine, 73 74 this single solution approach guarantees even bigger profits in the exploding global vaccine market that has doubled over the past decade from $20B in 2010 75 to $42B in 2018. 76 Dominated by the UK’s GlaxoSmithKline, France’s Sanofi and U.S. drug giants Merck and Pfizer, the vaccine market is projected to double again by 2026 to over $93B. 77

There are already reports from Wall Street predicting big gains in Biotech stocks based on multiple companies developing COVID-19 vaccines and new drugs. 78 One company, Moderna, which is partnering with the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Fauci, has seen a 78 percent increase in its stock price since it announced in February that its experimental messenger RNA vaccine was ready for clinical trials. 79 The company’s CEO has become a new billionaire overnight. 80

Big Pharma Getting More Money to Deliver COVID-19 Vaccines by Late 2020 or Early 2021

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 Mar. 27, 2020 that will cost American taxpayers over two trillion dollars. The federal legislation includes $27B for development of COVID-19 vaccines, drug therapies and purchase of pandemic medical supplies. The legislation did not include a cap placed on how much money drug companies can charge and profits they can make on the COVID-19 vaccines and drug therapies they develop with the use of money from the government. Already, there are questions being raised about just how far the price gouging will go when those COVID-19 drugs and vaccines are licensed by the FDA and recommended by the CDC. 81

On Mar. 30, the HHS Assistant Secretary of Preparedness and Response announced that the government is taking steps to “speed the development and manufacturing of vaccines to prevent COVID-19.” 82 The same day, Johnson & Johnson issued a press release stating that the Biomedical Advanced Research and Development Authority (BARDA) had awarded J&J’s Janssen Pharmaceutical Companies $1B to establish new U.S. vaccine manufacturing capabilities and additional production capacity outside the U.S and produce a global supply of more than 1 billion doses of the COVID-19 vaccine using AdVac® and PER.C6® technologies. 83 J&J plans to initiate human clinical studies in September 2020 and deliver the first batches of vaccine for emergency use authorization in early 2021. 84

BARDA was created by Congress in 2006 under the Pandemic and All Hazards Preparedness Act, 85 legislation that has given billions of dollars to DHHS since then to develop “bioterrorism” and pandemic influenza vaccines. 86 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. 87

According to a Mar. 30 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 are 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.” 88

Earlier in March, the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Fauci issued a press release on Mar. 16 announcing that a Phase1 human clinical trial conducted by Kaiser Permanente Washington Health Research Institute in Seattle has 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. 89

Moderna and NIAID are conducting human trials of the experimental mRNA-1273 COVID-19 vaccine without first conducting animal trials, which has always been an important part of the vaccine licensing process. 90 On Mar. 30, Moderna stated that its COVID-19 vaccine might be read for emergency use in some people, including healthcare workers, by the fall of 2020: 91

The Company further reported that while a commercially-available vaccine is not likely to be available for at least 12-18 months, it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020. Any emergency use would be subject to authorization by the appropriate regulatory agencies, based on the emergence of clinical data for mRNA-1273 that would support use of the vaccine prior to licensure."

An Apr. 3 Philadelphia Inquirer article trumpeting that “Coronavirus has created a new golden age for vaccines and Philly is at the heart of it,” 92 pointed out at least part of the heavy financial investments the U.S. government has made in vaccine development through BARDA since 2006:

“When the original BioShield funding ran out, Congress began a series of annual appropriations totaling about $1.5 billion a year to fund BARDA vaccine development efforts and to build up the emergency medical stockpile. A special $5 billion was appropriated for the multinational Ebola virus fight in 2015.”

The March 2020 CARES Act has multiplied those resources, splitting $27 billion between rebuilding the depleted medical stockpile and BARDA vaccine funding — on top of $6 billion appropriated for those purposes in the first anti-coronavirus bills last winter.” 

Experimental COVID-19 Vaccines Using Eight Different Platforms

Coronaviruses are a group of diverse, single-stranded, enveloped RNA viruses that cause a wide range of respiratory, gastrointestinal and neurologic illnesses with varying severity in animals and humans.  Most coronaviruses, including those causing the common cold, are not associated with significant mortality, with the exception of Severe Acute Respiratory Syndrome (SARS-CoV), which emerged in China in 2002, and the coronavirus causing Middle East Respiratory Syndrome (MERS-CoV), which was identified in Jordan and Saudi Arabia in 2012. 93 COVID-19 is referred to in the medical literature as severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or COVID-19. 94

Drug companies and government agencies racing to be the first to license a COVID-19 vaccine, are using different technology platforms to create experimental vaccines: inactivated virus; attenuated virus; protein subunit; virus-like particle, DNA, RNA and non-replicating vector. 95 Traditional vaccines contain attenuated or inactivated viruses and bacteria or proteins, as well as adjuvants, such as aluminum, to stimulate an immune response that produces artificial immunity. For example, older viral vaccines for smallpox and measles vaccine contain live attenuated viruses; injectable influenza vaccines contain inactivated viruses; the recombinant hepatitis B virus vaccine is a protein subunit vaccine, while the newer human papillomavirus (HPV) virus vaccine contains virus like particles. 

For the past two decades, researchers have been experimenting with new technology platforms, notably ones that introduce foreign DNA and RNA into cells of the body, to develop experimental vaccines for SARS, MERS, HIV and other diseases but, so far, none have been proven effective and safe for humans. 96

DNA and mRNA Vaccines: Flying Blind into Uncharted Territory

Gene-based vaccines encode a viral protein from a pathogen (like COVID-19) in human DNA or mRNA. DNA vaccines deliver pieces of DNA into human cells to stimulate the immune system to create antibodies specific to pathogenic proteins without causing disease. DNA vaccines require no culture or fermentation for production and no refrigeration after production because they are made in a lab using synthetic processes, and can be produced in large quantities for less money than traditional vaccines. 97

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. 98 99 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.” 100 Like DNA vaccines, mRNA vaccines can be produced in the lab using faster and less expensive process than traditional vaccines. RNA vaccines can be delivered with syringes, nasal spray or needle-free into the skin (patches).

Although neither DNA or mRNA vaccines have been tested in large-scale clinical trials, an Apr. 3 article in Chemical and Engineering News highlights 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 – are now “happening all at once.” 101

  • “It’s like building an airplane when you are flying,” said Inovio Pharmaceuticals CEO Joseph Kim.
  • “They have been described as the vaccines of the future,” says Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. “However, they have not yet been pressure-tested… The COVID crisis is a great opportunity for those technologies to be pushed.”
  • “It will be the first time that they will be tested in so many people,” says Wim Tiest, a former vaccine developer at GlaxoSmithKline now heading up a COVID-19 program at the Belgian mRNA vaccine company eTheRNA Immunotherapies.

But will spending lots of money to cut corners and speed up licensing of COVID-19 vaccines using experimental DNA and mRNA technology - or other types of new technology – end up putting millions of people at risk for vaccine failures and reactions leading to chronic illness?

There are nagging questions about DNA 102 and mRNA 103 vaccine platforms and they are not trivial. According to a 2011 article in Harvard College Global Health Review, DNA vaccine safety concerns include potential side effects as: 104

  • “chronic inflammation because the vaccine continually stimulates the immune system to produce antibodies;”
  • “possible integration of plasmid DNA into the body’s host genome, resulting in mutations, problems with DNA replication, triggering of autoimmune responses, and activation of cancer-causing genes;”

According to researchers at University of Pennsylvania and Duke University, mRNA vaccines also have potential safety issues: 105

  • Local and systemic inflammation;
  • Stimulation of auto-reactive antibodies;
  • Induction of a potent type 1 inteferon responses, which have been associated with inflammation and potential autoimmunity;
  • Presence of extracellular RNA, which may contribute to edema and pathogenic thrombus formation (blood clots).

Top COVID-19 Vaccine Candidates Being Tested

Following is a selection of companies identified by MarketWatch that are among those leading the race to be the first to get a COVID-19 vaccine licensed for global use: 106 107

Inovio Pharmaceuticals, Inc. (US). Inovio’s COVID-19 vaccine (INO-4800) is a DNA vaccine that will be tested in 30 clinical trials in the U.S., China and South Korea in April 2020. Headquartered in Pennsylvania, Inovio has partnered with Philadelphia’s Wistar Institute, Ology Bioservices, Inc. and Beijing Advaccine Biotechnology Co. in China 108 with plans to have 1 million doses of the vaccine ready for further trials or “emergency use” by the end of 2020.

Inovio received a $5M grant from the Gates Foundation to test a delivery device for INO-4800 and a $9M grant from CEPI to accelerate development of the COVID-19 vaccine. In partnership with Florida-based Ology Bioservices, Inc, Inovio secured a $11.9M contract with the Department of Defense for upcoming clinical trials and potential manufacturing of the vaccine for military personnel in the future. 109

Describing Inovio’s DNA vaccine, Precision Vaccinations states: 110

“This one-of-a-kind platform delivers optimized DNA into cells, where it is translated into proteins that activate an individual's immune system to generate a robust targeted T cell and antibody response. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Once inside the cell, the plasmids begin replicating, thereby strengthening the body's own natural response mechanisms.”

Johnson & Johnson, Inc. (US) J&J is working with BARDA, which has awarded the company $1B, to develop on an adenovirus vectored COVID-19 vaccine using J&J’s Advac technology and PER.C6 111 (cell line derived by transformation of embryonic retinal epithelial cells with human adenovirus type 5 E1 region gene) for production.

Phase 1 clinical trials of the J&J vaccine are scheduled for September 2020 and the company is planning to have investigational doses of vaccine available for “emergency use” by early 2021.

Moderna, Inc. (US) In partnership with the National Institute of Allergy and Infectious Diseases (NIAID), Moderna’s mRNA vaccine is being tested on adults in Phase 1 clinical trials in Seattle with funding from NIAID, BARDA and CEPI. Moderna plans to have vaccine doses available for “emergency use” by the end of 2020.

Pfizer, Inc. (US) and BioNTech (Germany) In a joint venture with BioNTech, Pfizer will develop and distribute an mRNA vaccine produced by BioNTech (BNT-162), expected to enter clinical testing by the end of April 2020 in Germany and the U.S.  BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group in China.

Dynavax Technologies Corp. (US) and Clover Biopharmaceuticals (China) China’s Clover Biopharmaceuticals has developed a protein-based subunit coronavirus vaccine candidate (COVID-19 S-Trimer) and Dynavax, a California based biotech company, is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018 for use in Clover’s COVID-19 vaccine. 

Dynavax’s CpG 1018 is a synthetic oligonucleotide adjuvant that is used in recombinant hepatitis B vaccine Heplisav-B. Dynavax is also collaborating with Australia’s University of Queensland as part of a CEPI initiative to develop a COVID-19 vaccine. 

GlaxoSmithKline (UK) and Clover Biopharmaceuticals, Inc. (China) GSK has an AS03 vaccine adjuvant system platform that it is making available to Australia’s University of Queensland and to Clover Biopharmaceuticals, Inc., a Chinese biotechnology company that will use GSK’s AS03 adjuvant in combination with a COVID-19 S-Trimer vaccine. S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. 

Sanofi (France). Sanofi is working with BARDA to use its recombinant DNA platform to test a preclinical vaccine candidate for SARS to manufacture a COVID-19 vaccine. In 2017, Sanofi acquired Protein Sciences, which had been developing a SARS vaccine.

Novavax (US). Novavax’s COVID-19 vaccine candidate (NVX-CoV2373) is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and the company’s proprietary Matrix-M™ adjuvant will be incorporated into it to stimulate high levels of neutralizing antibodies. 112 According to Novavax, Matrix-M is a sanponin-based adjuvant that contain purified saponin fractions mixed with synthetic cholesterol and a phospholipid to form stable particles that stimulate a strong immune response and “enhancing antigen presentation in the local lymph nodes.” 113

Novavax has received $4M from CEPI to develop a COVID-19 vaccine and Emergent Biosolutions, Inc. has indicated it would support contract development and manufacturing of the vaccine. The company plans to start Phase 1 clinical studies by June.

CureVac (Germany). CureVac, a German biotech company, which has received 80 million euros in funding from the European Commission, has developed an mRNA vaccine for COVID-19. It is planning to test the vaccine in human clinical trials (Phase 1 and Phase 2) this summer and wants to skip Phase 3 trials so the vaccine can be on the market by this fall. 114

Vaxart (US). Vaxart is a California based biotech company that has a partnership with Emergent Biosolutions, InC to develop Vaxart’s oral COVID-19 candidate. Based on Vaxart’s proprietary VAAST platform, the vaccine is a room temperature stable tablet that is swallowed and provides mucosal immunity.

Sweden Refused to Lockdown

Sweden, a country with a population of 10M people refused 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 has prevented the country from suffering the kind of economic meltdown being experienced by most other countries. 115

As of Apr. 10, 2020, Sweden has reported 870 deaths from COVID-19 and the nation’s public health agency reported that the numbers of confirmed infections are dropping.

 

NVIC Selected Resources, Statements and Commentaries

NVIC Answers to Frequently Asked Questions

NVIC COVID-19 Articles & Reports

NVIC’s The Vaccine Reaction COVID-19 Articles

 

References:

1 World Health Organization. Pneumonia of unknown cause – China. Jan. 5, 2020.

2 World Health Organization. WHO declares the new coronavirus outbreak a Public Health Emergency of International Concern. Jan. 30, 2020.

3 DHHS. Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus. Jan. 31, 2020.

4 Virginia Governor Ralph Northam. Temporary Stay at Home Order Due to Novel Coronavirus (COVID-19). March 30, 2020 to June10, 2020

5 U.S. Food and Drug Administration (FDA). Emergency Use Authorization for Vaccines Explained. Nov. 20, 2020.

6 U.S. Centers for Disease Control (CDC). Local Reactions, Systemic Reactions, Adverse Events and Serious Adverse Events: Pfizer COVID-19 Vaccine. Dec. 13, 2020.

7 U.S. Food and Drug Administration (FDA). Moderna COVID-19 Vaccine. Dec. 18, 2020.

8 U.S. Food and Drug Administration (FDA). Janssen COVID-19 Vaccine. Apr 27, 2020.

9 MedAlerts. Search the VAERS Database.

10 U.S. Food and Drug Administration (FDA). VAERS Overview. Mar. 29, 2019.

11 Goldstein S. Blood clots prevalent with Pfizer and Moderna Vaccine as with Astra Zeneca’s study. Dow Jones/Market Watch Apr. 16, 2021.

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