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


December 04 -- 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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