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SARS CoV-2 Virus and COVID-19 Vaccine Information

Find the Information You Need to Make an Informed Vaccine Decision

covid-19

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

Most coronaviruses, including those causing the common cold, are not associated with significant mortality. The novel SARS-Coronavirus-2 (SARS-CoV-2) identified in 2019 causes a collection of symptoms that can cause severe illness, which has become known as COVID-19. The SARS-CoV-2 virus is contagious.1 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 eight months5 and may be life-long.6 An August 2021 retrospective study of Israel’s second largest HMO, yet to undergo peer review, found that natural immunity “confers longer lasting and stronger protection against infection, symptomatic disease, and hospitalization caused by the Delta variant.”7

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COVID-19 Vaccine

New ways to make vaccines including new technologies and production platforms, such as mRNA vaccines, have  become favored over the older traditional ways to make vaccines in the COVID-19 vaccine race.8 9 Currently, three experimental COVID-19 vaccines and one licensed COVID-19 vaccine10 have been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for distribution and use in the U.S.11 12 Of the four vaccines in use, three are mRNA vaccines (Comirnaty, Pfizer-BioNTech and Moderna) and one utilizes a human adenovirus vector (Janssen). Nearly 300 different types of COVID-19 vaccines are being developed worldwide13 and several experimental COVID-19 vaccines may be given EUA status in the near future.14 15

U.S. Emergency Use Authorization does not mean that the FDA has evaluated all safety and efficacy data. Notably, in July 2021 the CDC reported that the fully vaccinated could still become infected and be capable of transmitting the virus to others16 and data from Israel reported vaccine effectiveness for the experimental Pfizer-BioNTech vaccine may be as low as 39 percent.17 While EUA status granted by the FDA to facilitates access to vaccines in a public health emergency, this status shields vaccine manufacturers and providers from liability under the Public Readiness and Emergency Preparedness Act (PREP Act).18 Under federal law, EUA vaccine recipients must “have the option to accept or refuse the vaccine” and be informed of its risks.19

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Quick Facts

SARS-CoV-2 & COVID-19

  • 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 2002-200320 and Middle Eastern Respiratory Syndrome (MERS) that was first reported in Saudi Arabia in 2012.21 SARS-CoV-2, which was identified in China in late 201922 and declared a global pandemic by the World Health Organization (WHO) in March 2020,23 24 has a much lower mortality rate than SARS or MERS.25
  • According to the U.S. Centers for Disease Control and Prevention (CDC), in 2020 about 94 percent of COVID-19 related-deaths occurred in persons over age 65 and individuals with underlying poor health conditions.26 Among those the CDC consider 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.27

Coronavirus Vaccine

  • On August 23, 2021 the FDA licensed and granted EUA status to Comirnaty COVID-19 vaccine, an mRNA vaccine developed BioNTech, for use in persons 16 years of age and older.28 The FDA also stated that use of Comirnaty and the experimental Pfizer-BioNTech mRNA COVID-19 vaccine are interchangeable due to having the same formulation. 29  Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended use of the 2-dose vaccine series in persons 16 years of age and older.30
  • There are three experimental COVID-19 vaccines authorized for use in the U.S. The mRNA COVID-19 vaccines by Pfizer-BioNTech and Moderna were granted an Emergency Use Authorization (EUA) in December 2020 by the U.S. Food and Drug Administration (FDA) for use in persons 16 years of age and older and 18 years of age and older, respectively. 31 32 In May of 2021 the experimental Pfizer-BioNTech vaccine was additionally authorized by the FDA for use in children and young as 12 years of age with a third dose authorized for the immunocompromised.33 In February 2021, Janssen Biotech, Inc. of Johnson & Johnson, was granted an EUA by the FDA for an experimental COVID-19 vaccine, which uses a human adenovirus vector,34 35 for use in persons 18 years of age and older.36

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Learn More About SARS-CoV-2 Virus and COVID-19 Vaccine

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.

« Return to Vaccines & Diseases Table of Contents

Updated July 22, 2021

References

1 U.S. Centers for Disease Control and Prevention. How COVID-19 Spreads. In: COVID-19. July 14, 2021.

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; 9:e58728.

3 U.S. Centers for Disease Control and Prevention. Symptoms of COVID-19. In: COVID-19. Feb. 22, 2021.

4 WebMD. Complications Coronavirus Can Cause Aug. 9, 2021.

5 National Institutes of Health (NIH) Lasting immunity found after recovery from COVID-19 NIH Research Matters Jan. 26, 2021.

6 Washington University School of Medicine in St. Louis. Good news: Mild COVID-19 induces lasting antibody protection. May 24, 2021.

7 Gazit S, Shlezinger R, Perez G, et al. Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections. medRxiv Aug. 25, 2021.

8 Tregoning JS, Brown ES, et al. Vaccines for COVID-19. Clin Exp Immunol. 2020 Nov;202(2):162-192.

9 Cohen J. Vaccine designers take first shots at COVID-19Science Magazine Apr. 3, 2020.

10 Malarkey MA, Gruber MF. BLA Approval – BioNTech Manufacturing GmbH. FDA Aug. 23, 2021.

11 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine. Aug. 18, 2021.

12 U.S. Food and Drug Administration. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. Feb. 27, 2021.

13 World Health Organization. COVID-19 vaccine tracker and landscape. Aug. 27, 2021.

14 Knapp A, Rosenbaum L. Here’s What You Need to Know About Astra Zeneca’s COVID-19 Vaccine. Forbes Nov. 23 2020.

15 Robert-Guroff M. Replicating and non-replicating viral vectors for vaccine development. Curr Opin Biotechnol. December 2007;18(6):546-556.

16 U.S. 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.

17 Anderson M. Pfizer shot 39% effective against infection in Israel; 91% effective against severe disease. Becker’s Hospital Review July. 23, 2021.

18  The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Congressional Research Service. Mar. 19, 2021.

1921 U.S. Code § 360bbb–3(a)(2)(B) – Authorization for medical products for use in emergencies – Approval Status of Product. Cornell Law School.

20 U.S. Centers for Disease Control and Prevention. Frequently Asked Questions about SARS. In: Severe Acute Respiratory Syndrome (SARS). May 3, 2005.

21 U.S. Centers for Disease Control and Prevention. About MERS. In: Middle East Respiratory Syndrome (MERS). Aug. 2, 2019.

22 Wu YC, Chen CS, Chan YS. The outbreak of COVID-19: An overview. J Chin Med Assoc March 2020; 83(3): 217-220.

23 Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed March 2020; 91(1): 157-160.

24 Fisher BL. Coronavirus (COVID-19) Pandemic: NVIC Special Report. National Vaccine Information Center (NVIC) February-June 2020. 

25 Hewings-Maven Y. How do SARS and MERS compare with COVID-19? Medical News Today Apr. 10, 2020.

26 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.

27 U.S. Centers for Disease Control and Prevention. People with Certain Medical Conditions. In: COVID-19. Aug. 20, 2021.

28 Malarkey MA, Gruber MF. BLA Approval – BioNTech Manufacturing GmbH. FDA Aug. 23, 2021.

29 Hinton DM. Letter of Authorization (reissued), In: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine – Regulatory Information. FDA Aug. 23, 2021.

30 Jenco M. CDC panel OKs COVID-19 vaccines; discusses myocarditis, boosters. AAP News Aug. 30, 2021.

31 U.S. Food and Drug Administration (FDA). Pfizer-BioNTech COVID-19 Vaccine. Aug. 18June 25, 2021.

32 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine. Aug. 12, 2021.

33 Hinton DM. Letter of Authorization (reissued), In: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine – Regulatory Information. FDA Aug. 23, 2021.

34 Levine H. The 5 Stages of COVID-19 Vaccine Development: What You Need to Know About How a Clinical Trial Works. Johnson & Johnson Sept. 23, 2020.

35 Weintraub A. J&J COVID-19 vaccine candidate protects monkeys after single dose. Fierce Biotech July 30, 2020.

36 U.S. Food and Drug Administration. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. Feb. 27, 2021.


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