FDA to review Pfizer, BioNTech's vaccine EUA on December 10

By The Science Advisory Board staff writers

November 20, 2020 -- The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) has set a date of December 10 to discuss the request for emergency use authorization (EUA) of Pfizer and BioNTech's COVID-19 vaccine candidate.

"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 in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19," said FDA Commissioner Dr. Stephen Hahn, in a statement.

The agency will make background materials available to the public, including the agenda and committee roster at least two days prior to the meeting. Generally, the advisory committee is made up of a chair, members with scientific and public health expertise, and a consumer, industry, and sometimes a patient representative.

During the week of November 23, the FDA intends to issue a Federal Register notice with details of the meeting, including information about a section for public comments. The FDA will review public comments.

The FDA plans to livestream the VRBPAC meeting on the agency's website in addition to its YouTube, Facebook, and Twitter channels.

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