FDA Advisory Committee OKs Pfizer-BioNTech COVID-19 Vaccine

THURSDAY, Dec. 10, 2020 — The U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee today voted to recommend emergency use authorization (EUA) of the COVID-19 vaccine manufactured by Pfizer and BioNTech.

The decision came at the end of an all-day meeting that included presentations of vaccine safety and efficacy data as well as an open discussion with the committee that was available for public viewing and included public comment. The committee, made up of independent scientific and public health experts from around the United States, was asked, “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?” The vote was yes.

In a statement, FDA Commissioner Stephen M. Hahn, M.D., said that after the meeting, “FDA career staff will take the committee’s input into account as they continue their review of the EUA request to determine whether it has met the standards for safety and effectiveness for issuance of an EUA, as well as refine the instructions for use and the informational materials to be provided to those receiving the vaccine.” He added that FDA staff “feel the responsibility to move as quickly as possible through the review process,” but pledged to do so while protecting public health and ensuring the authorized vaccine meets the agency’s “rigorous standards for safety and effectiveness.”

Officials of Operation Warp Speed have said that the vaccine will be distributed to the states within 24 hours of the FDA granting EUA. “When the EUA decision comes [through], distribution to the American people becomes immediate within 24 hours. That’s our goal. That’s what we’re striving for,” Army Gen. Gustave F. Perna, chief operating officer of Operation Warp Speed, said during a media briefing earlier this month.

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