Why the FDA’s Pfizer Hearing This Week Is So Important’

The meeting has significant implications for Covid-19 vaccine approval stateside

Photo by Markus Spiske on Unsplash

On Thursday a medical expert advisory panel will review the Covid-19 vaccine developed by Pfizer and BioNTech in order to help the U.S. Food and Drug Administration (FDA) make a ruling on whether to approve the vaccine for emergency use.

The daylong public meeting will include reviews of the companies’ clinical trial data and discussions on how the vaccine will continue to be monitored for safety and effectiveness, and how it will be distributed. You can review the agenda here and the briefing materials here. You can watch the meeting below on Thursday beginning at 9 a.m. EST.

At the end of the meeting, the advisory panel is expected to make a recommendation about whether or not the FDA should approve the companies’ Covid-19 vaccine for emergency use. The FDA usually follows the recommendation of the panel, though not always. The decision could happen days or weeks after the advisory meeting.

If the panel recommends the vaccine for emergency use authorization (EUA) and the FDA moves forward with that recommendation, then the vaccine will begin to be distributed. Operation Warp Speed has vowed to begin vaccine distribution within 24 hours of FDA authorization, and there will be millions of doses available right away. However the number of people who need to be vaccinated is incredibly vast, and the undertaking will likely go well into 2021.

It’s been recommended by a U.S. Centers for Disease Control and Prevention advisory committee that the first people to receive a vaccine should be people living in long-term care facilities and health care workers at risk of Covid-19. (You can check out where you might land in the vaccine line, here.)

Notably, the Pfizer/BioNTech vaccine is already approved for use in the U.K., and the first recipients received the vaccine on Tuesday. The company says the vaccine is safe and is 95% effective, though the public hasn’t had access to the detailed study data. A more thorough review of the data should happen on Thursday.

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Pfizer’s Vaccine Offers Strong Protection After First Dose

The Food and Drug Administration’s first analysis of the clinical trial data also found that the coronavirus vaccine…

medium.com

While the next step could be EUA, the FDA still wants pharmaceutical companies that have developed Covid-19 vaccines to undergo the full approval process as well. Emergency approval can be granted based on two months of safety follow-up, but a full approval will look at six months of safety data.

I asked some of the Blog editors and writers what questions they are hoping will be answered during Thursday’s hearing, and I’ve listed a few of them below. We will provide a follow-up to the meeting at the end of the day of Thursday.

The Blog’s key questions:

• Will there be any clarity or hints around protection against transmission? Right now data suggests that the vaccines provide protection against Covid-19 illness, but it’s unclear whether a vaccinated person could still spread the virus. Read more about that question here.
• What will happen to people in the clinical trials who got a placebo? There’s debate over when trial volunteers who did not receive the vaccine might be able to get vaccinated. Read more about that here.
• Will there be discussion over whether people who have been infected with Covid-19 should get the vaccine? Data suggests natural immunity is not safer than a vaccine, but there’s some interesting discussion here.
• What are all the vaccine side effects and what are the risks, if any? Are there any concerns for people with preexisting conditions?
• Are there any hints on how long protection can last? There are questions remaining over whether people can get a Covid-19 vaccine once and be done, or if people will need a booster.
• Will there be discussion on availability? How many doses can Pfizer provide and when? This will help states and individuals get a sense of vaccination timelines.