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SARS CoV-2 Virus and COVID-19 Vaccine Information
SARS-Coronavirus-2 (SARS-CoV-2) and COVID-19
Most coronaviruses, including those causing the common cold, are not associated with significant mortality. The novel SARS-Coronavirus-2 (SARS-CoV-2) identified in 2019 causes a collection of symptoms that can cause severe illness, which has become known as COVID-19. The SARS-CoV-2 virus is contagious1 and infected persons can be asymptomatic2 or exhibit symptoms ranging from mild to severe. Symptoms include fever; chills; cough; shortness of breath/difficulty breathing; fatigue; muscle, joint or body aches; rash; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting and diarrhea.3
Complications of SARS-CoV-2 include pneumonia, acute respiratory failure, Acute, Respiratory Distress Syndrome (ARDS), acute kidney, liver, and heart injury, septic shock, disseminated intravascular coagulation (DIC), rhabdomyolysis (muscle breakdown), chronic fatigue syndrome, blood clots and death. Many complications may be caused by a condition known as a cytokine storm.4
Research on natural immunity from SARS-CoV-2 infection varies and suggests that durable immunity to the virus lasts for at least 20 months5 and may be life-long.6 An August 2021 retrospective study of Israel’s second largest HMO found that natural immunity “confers longer lasting and stronger protection against infection, symptomatic disease, and hospitalization caused by the Delta variant.”7 Click to learn more about SARS-CoV-2 virus…
New ways to make vaccines including new technologies and production platforms, such as mRNA vaccines, have become favored over the older traditional ways to make vaccines in the COVID-19 vaccine race.8 9 Messenger RNA (mRNA) vaccines are gene based vaccines that involve injecting lipid nanoparticles containing mRNA (genetic code) that enable the vaccine to get past the cell wall, into the intracellular space, then causes the cell’s ribosome to make viral proteins (antigen that stimulate the immune system.)10 In essence, an mRNA vaccine tricks the body into producing the viral proteins to trigger an immune response.11
There are two mRNA COVID-19 vaccines licensed and recommended in the U.S. by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC).12 13 There are four additional COVID-19 Vaccines are available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines for use in infants and children aged 6 months through 4 years and for children five through 11 years of age14 and one mRNA COVID-19 vaccine for use in infants aged 6 months through 11 years.15 There is one protein subunit vaccine authorized for use in individuals 12 years of age and older.16
Under EUA authority, the FDA Commissioner may permit “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.”17 EUA status, however, also shields vaccine manufacturers and providers from liability under the Public Readiness and Emergency Preparedness Act (PREP Act).18
The EUA status granted to these vaccines does not mean that the FDA has evaluated all safety and efficacy data. For example, the CDC reported in July 2021, after general use in the population under EUA status, that COVID-19 vaccines did not prevent infection the fully vaccinated or transmission of the virus by the fully vaccinated.19 Additionally, multiple studies have found that vaccine effectiveness wanes quickly and vaccinated persons may be more at risk of infection.20 21 22 23 24 25 26
NVIC encourages consumers to make informed vaccination decisions and to read the FDA fact sheet and other information and resources provided on our website. Click to learn more about COVID-19 vaccines…
SARS-CoV-2 & COVID-19 Quick Facts
- A few coronavirus strains can cause very severe respiratory disease with significant mortality, such as Severe Acute Respiratory Syndrome (SARS) that emerged in China in 2002-200327 and Middle Eastern Respiratory Syndrome (MERS) that was first reported in Saudi Arabia in 2012.28 SARS-CoV-2, which was identified in China in late 201929 and declared a global pandemic by the World Health Organization (WHO) in March 2020,30 31 has a much lower mortality rate than SARS or MERS.32
- In 2020, the U.S. Centers for Disease Control and Prevention (CDC) reported that about 94 percent of COVID-19 related-deaths occurred in persons over age 65 and individuals with underlying poor health conditions.33 According to the CDC, those considered to be at highest risk for severe COVID-19 disease are the immunocompromised; pregnant women; individuals with chronic heart, lung or kidney disease; the obese; type 2 diabetics; and individuals with cancer, Down’s syndrome, sickle cell disease and thalassemia. There are other chronic health conditions that might increase risks for severe COVID-19 disease, including asthma, high blood pressure, dementia and neurologic conditions, liver disease, cystic fibrosis, and type 1 diabetes.34 Click to read more COVID-19 Quick Facts…
Coronavirus Vaccine Quick Facts
- On Mar. 10, 2020, the U.S. Secretary of the Department of Health and Human Services (DHHS) declared the COVID-19 pandemic a public health emergency and invoked the 2005 Public Readiness and Emergency Preparedness (PREP) Act. The public health emergency ended in the U.S. on May 11, 2023. However, COVID-19 vaccines remain a public health emergency “countermeasures” and continue to fall under the PREP Act, which shields manufacturers and vaccine providers from liability. The Countermeasures Injury Compensation Program (CICP) awards compensation to those injured by countermeasure vaccines.35 36 37 38
- There are two COVID-19 vaccines for use in the U.S. Comirnaty mRNA COVID-19 vaccine,39 developed and manufactured by Pfizer-BioNTech, and Spikevax mRNA COVID-19 vaccine,40 developed and manufactured by Moderna. Both vaccines are monovalent mRNA COVID-19 vaccines containing the SARS-CoV-2 Omicron variant XBB.1.5. and are approved for use in individuals age 12 years and older.
- Additional COVID-19 Vaccines available for use through Emergency Use Authorization (EUA) by the FDA. These vaccines include two mRNA COVID-19 vaccines produced by Pfizer-BioNTech for use in infants and children aged 6 months through 4 years and for children five through 11 years of age41 and one mRNA COVID-19 vaccine produced by Moderna for use in infants aged 6 months through 11 years.42 There is one protein subunit vaccine, Novavax, authorized for use in individuals 12 years of age and older. 43 Click to read more COVID-19 Quick Facts…
IMPORTANT NOTE: NVIC encourages you to become fully informed about COVID-19 and the COVID-19 vaccine by reading all sections in the table of contents, which contains many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
2 Rivett L, Sridhar S, Sparkes D, et al. Screening of healthcare workers for SARS-CoV-2 highlights the role of asymptomatic carriage in COVID-19 transmission. ELife 2020.
5 Alejo JL, Mitchell J, Chang A, et al. Prevalence and Durability of SARS-CoV-2 Antibodies Among Unvaccinated US Adults by History of COVID-19. JAMA Mar 15, 2022; 327(11):1085-1087.
6 Washington University School of Medicine in St. Good news: Mild COVID-19 induces lasting antibody protection. May 24, 2021.
7 Gazit S, Shlezinger R, Perez G, et al. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort Study. Clin Infect Dis. July 1, 2022; 75 (1): e545–e551.
10 Cross R. Will the coronavirus help mRNA and DNA vaccines prove their worth? Chemical and Engineering News Apr. 3, 2020.
14 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Provider. Sept. 11, 2023.
15 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine Fact Sheet for Healthcare Provider. Sept. 11, 2023.
16 U.S. Food and Drug Administration. Novavax COVID-19 Vaccine Fact Sheet for Healthcare Provider Administering Vaccine. Mar. 28, 2023.
19 US Centers for Disease Control and Prevention. Vaccination to Prevent COVID-19 Outbreaks with Current and Emergent Variants — United States, 2021. In: Emergency Preparedness and Response. July 27, 2021.
20 Cohn BA, Cirillo PM, Murphy CC, et al. SARS-CoV-2 vaccine protection and deaths among US veterans during 2021. Science Jan 21, 2022; 375(6578):331-336.
21 Lyngse FP, Mortensen LH, Denwood MJ, et al. Household transmission of the SARS-CoV-2 Omicron variant in Denmark. Nat Commun 2022.
22 Buchan SA, Chung H, Brown KA, et al. Estimated Effectiveness of COVID-19 Vaccines Against Omicron or Delta Symptomatic Infection and Severe Outcomes. JAMA Netw Open. 2022.
23 Ferdinands JM, Rao S, Dixon BE, et al. Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance — VISION Network, 10 States, August 2021–January 2022. MMWR August 2021; 71(7);255–263.
24 Altarawneh HN, Chemaitelly H, Ayoub HH. Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections. N Engl J Med. July 7, 2022; 387:21-34.
25 Lin DY. Effects of Vaccination and Previous Infection on Omicron Infections in Children. N Engl J Med. Sept. 7, 2022; 387:1141-1143.
26 Tseng HF, Ackerson BK, Bruxvoort KJ. Effectiveness of mRNA-1273 vaccination against SARS-CoV-2 omicron subvariants BA.1, BA.2, BA.2.12.1, BA.4, and BA.5. Nat Commun. Jan 12, 2023.
31 Fisher BL. Coronavirus (COVID-19) Pandemic: NVIC Special Report. National Vaccine Information Center (NVIC) June 2020.
33 Garg S, Kim L, Whitaker M, et al. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 — COVID-NET, 14 States, March 1–30, 2020. MMWR 2020; 69(15): 458-464.
35 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Apr. 13, 2022.
36 Garde D., Branswell H. 6 burning questions Congress could push Covid-19 vaccine makers to answer today. Stat News July 20, 2020.
37 Fisher BL. Parpia R. 2005 PREP Act and 1986 Act Shield Vaccine Manufacturers from Liability The Vaccine Reaction Aug. 10, 2020.
38 U.S. Department of Health & Human Services. HHS Secretary Xavier Becerra Statement on End of the COVID-19 Public Health Emergency. May 11, 2023.
41 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Provider. Sept. 11, 2023.
42 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine Fact Sheet for Healthcare Provider. Sept. 11, 2023.
43 U.S. Food and Drug Administration. Novavax COVID-19 Vaccine Fact Sheet for Healthcare Provider Administering Vaccine. Mar. 28, 2023.