Pfizer’s Covid-19 Vaccine Wins Crucial Vote, Now One Step Away From FDA Authorisation

Pfizer’s Covid-19 Vaccine Wins Crucial Vote, Now One Step Away From FDA Authorisation

The covid-19 vaccine developed by Pfizer and BioNTech is one big step closer to reaching the American public. On late Thursday afternoon, a group of outside experts assembled by the Food and Drug Administration largely voted to recommend the vaccine for emergency use in people ages 16 and older. The vote will likely soon be followed by the FDA granting an emergency use authorisation for the vaccine, though there is no clear deadline for that decision.

The over eight-hour advisory committee meeting held today featured presentations and discussion of the trial data collected by Pfizer and BioNTech. Other outside scientists, doctors, and members of the public also offered testimony. Many speakers offered support for the vaccine, yet a few voiced concerns over granting the vaccine an EUA so quickly. One speaker in particular, who claimed to have a child injured by vaccines, appeared to imply that Pfizer/BioNTech’s vaccine could contain “aborted fetal cells,” which is false.

The data presented by Pfizer/BioNTech is based on a large phase III trial involving over 44,000 volunteers in the U.S. In this trial, the two-dose vaccine appeared to be 95 per cent effective at preventing symptoms of covid-19 a week after the second dose was received. Common adverse effects included injection site pain, fatigue, fever, and headache.

The 22-member panel did not vote unanimously for the FDA to grant an EUA. Seventeen committee members voted yes, four voted no, and one abstained. However, in the lead-up discussion to the vote, several members said they were only uncomfortable with recommending its use to people ages 16-17, not to the general adult public, given the limited data available right now (Pfizer/BioNTech have since enrolled younger children in their ongoing trial). Unlike a typical committee meeting, the dissenting votes were not allowed to voice their reasoning for the vote.

The FDA rarely disagrees with the recommendations given by these expert panels, and its own review of the trial data was favourable. So it’s almost certain that the agency will grant an emergency use authorisation, possibly tomorrow or next week.

This would make the Pfizer/BioNTech vaccine the first in line to be given to Americans, following similar approvals in Canada and the UK in the past two weeks. If the vaccine is approved Friday, states such as New York are expected to receive doses as soon as this weekend, while private mail carriers FedEx and UPS have pledged to work together in distributing the vaccine to states as quickly as possible.

For now, things are still technically up in the air. But probably not for long.

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