What to Know Ahead of the FDA’s Review of Pfizer’s COVID-19 VaccineDecember 10, 2020
The Food and Drug Administration’s Vaccine Advisory Committee will hold a day-long open meeting to discuss whether or not to authorize Pfizer’s COVID-19 vaccine.
Starting at 9 a.m. Thursday, the FDA will present its review of the Pfizer-BioNTech vaccine data to its independent panel of outside experts. Their official title is the “Vaccines and Related Biological Products Advisory Committee.”
The acting chair is Dr. Arnold Monot, who is a world-renowned epidemiologist from the University of Michigan School of Public Health. Monto has been tracking viruses and studying vaccines for more than 50 years.
The meeting will be streamed live on YouTube, Twitter, and the FDA’s website. The panel is made up of top experts in immunology, virology, and infectious diseases. There is a voting member from the public and a non-voting member representing the pharmaceutical industry.
Expect the panel to raise questions about the time of follow up. Some previously pushed for more than two months of data. The panel will weigh that against the cost of waiting longer.
Other expected points of discussion include the allergic reaction seen in two U.K. health care workers, the safety of mRNA vaccines, distribution plans, and how the vaccine’s safety will continue to be monitored after an authorization.
Do not expect to see any discussion of authorization of the vaccine for children under 16 or pregnant women. There is already agreement that additional study is needed in those groups. The meeting will end with a vote to recommend an emergency use authorization be granted or not.
The FDA is not required to follow the committee’s recommendation, but it generally does. If the advisory committee votes yes, the FDA could give the green light to the Pfizer vaccine within a day or two.
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