Home Business 6 things to know before FDA panel votes today

6 things to know before FDA panel votes today

A vial of the Pfizer/BioNTech COVID-19 vaccine.

Liam McBurney | Reuters

A Food and Drug Administration panel is scheduled to vote Thursday on whether to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use.

The non-binding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, an outside group of experts in infectious diseases and vaccines, is the last step before the FDA is likely to give the final OK to distribute the potentially lifesaving doses throughout the United States.

While the FDA does not have to follow the advisory committee’s recommendation, the agency often takes its advice. Emergency use approval would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.3 million Americans and killed at least 288,000 as of Wednesday, according to data compiled by Johns Hopkins University. Hospitals across the U.S. already have a higher load of Covid patients than ever before, and the country’s outbreak is primed to set even more grim records.

Pfizer’s vaccine would be the first approved for use in the U.S.

Here’s what to expect:

1.) When are they voting?

The FDA advisory meeting is scheduled to run from 9 a.m. ET to 6 p.m. ET. The vote is likely to happen towards the end of the meeting. Before the vote, outside medical experts will assess Pfizer’s clinical trial data and offer their opinions on the vaccine, including whether the benefits outweigh the risks for an emergency use authorization.

Emergency use authorization means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as a full approval, which can typically take months. So far, Pfizer has only submitted two months of follow-up safety data, but the agency usually requires six months for full approval.

The advisory committee, which is expected to include 30 members for the meeting, has already been reviewing documents sent by the FDA on Pfizer’s vaccine, said Dr. Paul Offit, a voting member of the committee. Those documents were made available to the public on Tuesday. “The public will see everything that we see,” Offit added.

2.) What happens next?

3.) How soon will the vaccine be distributed?

4.) When will I get the vaccine?

5.) Should I get the vaccine if I’ve had Covid?

6.) What about side effects?