December 12, 2020

Capping a nearly year-long effort, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization last Friday to Pfizer/BioNTech’s mRNA vaccine against SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19).

This came just one day after the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted (17-4 with 1 abstention) to determine that the benefits of the Pfizer-BioNTech vaccine outweigh the risks in persons at least 16 years of age. (Some of the members who voted “no” indicated they would have voted “yes” if the specification was for persons 18 years of age or older.)

This mRNA vaccine is the first of its kind: it contains ribo-nucleic acid (RNA) encased in lipid nanoparticles. The nanoparticles deliver the RNA to cells in the body of the person receiving the vaccine. Ribosomes, which are parts of your cells, then transcribe the RNA into spike protein which then produce an immune response.

In the United States, the first shipment of 3 million doses will be reserved for health-care workers and nursing homes. {W|Pfizer}} expects to mmanufacture 20 million doses of the vaccine in time to be administered this year, and 100 million by March. After nursing-home residents and health-care workers, the next people in line to receive the vaccine will be those over 65 years of age and those with significant co-morbidities and risk factors. The general public in the United States can expect to have vaccines available in their doctors’ offices or pharmacies later in the spring of 2021.

The vaccine must be stored at a temperature of -70°C (-94°F) ±10°C, which can be accomplished using ultra-low-temperature freezers or dry ice.

The vaccine is designed to be taken twice; the second dose should be administered 3 weeks after the first.

The legal authority for emergency-use authorization is in section 564 of the Federal Food, Drug, and Cosmetic Act. EUA is less than a full approval, and represents a determination by the FDA that

• The disease must be serious or life-threatening.
• The vaccine may be effective to prevent, diagnose, or treat the disease.
• The known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine.
• No adequate, fully-approved, alternative product is available to prevent the disease.

The vaccine development process normally takes 5–20 years, but scientists developed the new vaccines in record time by building on their experience with SARS and by performing many of the development, manufacturing, and testing steps in parallel.

COVID-19 is a respiratory and hematologic disease caused by SARS-CoV-2, a positive-sense single-stranded RNA virus believed to have originated in bats. The virus typically causes a cold-like or flu-like illness, but illness severity ranges widely from no symptoms at all to death, and it is very contagious. Although many cases are asymptomatic (50% of all transmission is from asymptomatic and pre-symptomatic persons), the disease has killed over 1.5 million people (294,874 of whom are in the United States) in only a year.

The FDA originally planned to issue the EUA over the weekend, but Donald Trump directed the FDA commissioner to issue the EUA by the end of the day yesterday. The next steps are for the vaccine to be manufactured and distributed; for the VRBPAC to evaluate a similar vaccine made by Moderna; and for other vaccines to be developed, as no one single company will be able to manufacture enough vaccines for 8 billion people. Researchers are testing 57 different vaccines against the coronavirus.

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• “FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine” — Food and Drug Administration, December 11, 2020
• “Covid-19 Vaccine Tracker” — The New York Times, December 11, 2020
• “Who will get the coronavirus vaccine first?” — The New York Times, December 11, 2020
• “Covid-19 Live Updates: F.D.A. Expected to Issue Pfizer Vaccine Authorization on Friday Evening” — The New York Times, December 11, 2020
• Reis Thebault, Meryl Kornfield, Carolyn Y. Johnson, Laurie McGinley, Paulina Firozi, Kim Bellware, Erin Cunningham, Hamza Shaban, Miriam Berger. “U.S. sets death record again as FDA advisers recommend Pfizer-BioNTech vaccine” — The Washington Post, December 10, 2020
• Josh Dawsey and Laurie McGinley. “White House orders FDA chief to authorize Pfizer-BioNTech vaccine Friday or submit his resignation” — The Washington Post, December 11, 2020
• Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Gonzalo Pérez Marc, M.D., Edson D. Moreira, M.D., Cristiano Zerbini, M.D., Ruth Bailey, B.Sc., Kena A. Swanson, Ph.D., et al., for the C4591001 Clinical Trial Group. “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine” — New England Journal of Medicine, December 10, 2020
• “Public hearing of the Vaccines and Related Biological Products Advisory Committee” —  December 10, 2020
• “Covid 19 Vaccine U.S. Distribution Fact Sheet” — Pfizer, November 20, 2020
• “COVID-19, SARS-CoV-2 and the Pandemic (Lecture 1)” — MIT, September 3, 2020
• “COVID-19, SARS-CoV-2 and the Pandemic (Lecture 8: Vaccines)” — MIT, September 3, 2020
• “Coronavirus Resource Center” — Johns Hopkins University, December 11, 2020
• “Morbidity and Mortality Weekly Report” — Centers for Disease Control, December 11, 2020