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FDA sets Dec. 10 meeting to weigh Pfizer/BioNTech vaccine authorization

- The Food & Drug Administration has set Dec. 10 as the meeting of an
advisory committee to discuss the request for Emergency Use Authorization
by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) for their COVID-19
vaccine.
- That's when the Vaccines and Related Biological Products Advisory
Committee will gather to discuss advice it will provide to the FDA on the
EUA request. That meeting will be live-streamed on the FDA's YouTube,
Facebook and Twitter channels, as well as from its website.
- It will also make background materials available to the public no
later than two business days before the meeting.
- Injections of the vaccine could follow almost immediately upon full
FDA approval of the EUA.
- "The FDA recognizes that transparency and dialogue are critical for
the public to have confidence in COVID-19 vaccines," says FDA
Commissioner
Stephen Hahn. "I want to assure the American people that the FDA's
process
and evaluation of the data for a potential COVID-19 vaccine will be as
open
and transparent as possible."
- He couldn't predict how long the process would take but "A discussion
about the safety and effectiveness of Pfizer and BioNTech's vaccine with
this committee, made up of outside scientific and public health experts
from around the country, will help ensure clear public understanding of
the
scientific data and information that the FDA will evaluate."
- After hours: PFE+0.7%; BNTX+0.5%.





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