Wednesday, November 10, 2021

Video: F.D.A. Panel Greenlights Pfizer Vaccine


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F.D.A. Panel Greenlights Pfizer Vaccine

An advisory panel of the Food and Drug Administration recommended authorization of the Pfizer-BioNTech coronavirus vaccine. The F.D.A. is expected to make its formal announcement in the coming days.

“Today, we will be considering whether to make available to millions of Americans and as-yet investigational vaccine that has been developed, tested and reviewed in record time, with additional testing still underway in ongoing studies. The American public demands and deserves a rigorous, comprehensive and independent review of the data. We have explained that we expect these analyses to include a median follow-up duration of at least two months after completion of the full vaccination regimen. The reasons for that expectation are that, first of all, it allows time for potential immune- mediated adverse events to be evaluated, understanding that uncommon, but clinically significant immune- mediated adverse events to preventive vaccines generally have onset within the first six weeks following vaccination.” “OK, I think we are going to vote. So. …” “Great. So, let’s pull up the voting question on the side. And Dr. Monto, you can read questions for. …” “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?” “You’ll have two minutes to cast your vote after the question is read. And once all of the votes have been placed, we will broadcast the results and read the individual votes aloud for the record. So we do have a favorable vote, and that concludes this portion of the meeting. So I will now hand the meeting back over to Dr. Monto. Thank you, everybody.”

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