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COVID-19 Vaccine and SARS CoV-2 Mutational Variant Update

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by Stuart M. Caplen MD


Vaccines were created and produced in record time in 2020 to combat COVID-19. As of May 2021, there are 14 vaccines either approved fully or for emergency use around the world. 27 vaccines are in phase 3 testing and 85 in phase 1 or 2 testing. Three are currently approved for use in the United States.[1] Given the vast number of vaccines in the pipeline, in the future there may be a tsunami of new vaccines to choose from. In addition, some SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) mutational variants are increasingly more infective, and potentially resistant to current vaccines. Here is what is known now.


Pfizer/BioNTech RNA vaccine (Tozinameran or BNT162b2)


The Pfizer/Biontech vaccine, also called tozinameran, or BNT162b2, is an RNA vaccine which uses replicated parts of the SARS-CoV-2 virus’s RNA to induce an immune response. It was approved by the FDA on December 11, 2020 for emergency use in two doses, three weeks apart.[1] Initially, it was found to have 95% efficacy in preventing infection.[1] A more recent Pfizer press release, of yet unpublished data on 12,000 study participants, reported that the BNT162b2 vaccine had an efficacy of 91.3% against COVID-19, measured seven days to six months after the second dose. It was 100% effective against severe disease according to CDC criteria, and 95.3% effective against severe disease according to FDA criteria (FDA criteria has some clinical measurements in its definition to explain some of the difference.[2]). The vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent.[3]


In clinical studies, adverse reactions from this vaccine included…….


Conclusion:

Read the conclusion on FibonaccMD.app about the 3 Covid-19 vaccines currently approved for use in the US and a summary of a few of the critical variants.


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ABOUT THE AUTHOR


Stuart M. Caplen, MD, FACEP, MSM

Dr. Caplen is a former emergency physician and emergency department medical director, now retired from clinical practice. His current interests include how quality is produced and maintained in health care, and he has greenbelt certification in lean/six sigma.


References


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[2] COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration, February 2021. Retrieved from: www.fda.gov


[3] Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study, Pfizer, April 01, 2021. Retrieved from: www.pfizer.com


[4] Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020, CDC, Morbidity and Mortality Weekly Report, January 15, 2021 / 70(2);46–51. Retrieved from: www.cdc.gov


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