FDA Approval for Pfizer COVID Vaccine

HBI Blog / FDA Approval for Pfizer COVID Vaccine

Thursday, December 10, 2020 may become a historical day for mankind as FDA has called for an advisory committee meeting on that day to discuss Pfizer COVID vaccine approval.


FDA has scheduled the meeting with Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss Emergency Use Authorization (EUA) of the COVID-19 vaccine from Pfizer in partnership with BioNTech Manufacturing GmbH.

The FDA is willing to make several background materials available to the public, which includes meeting agenda and committee roster, two business days prior to the meeting.

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. 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,” said FDA Commissioner Stephen M. Hahn, M.D. 

The time between the submission of the EUA request and the VRBPAC meeting will allow FDA with enough time to evaluate the data thoroughly and get prepared for public discussion.

FDA has not confirmed the timeline, but Pfizer and U.S Health Secretary Alex Azar expecting the approval by mid-December.

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