23 November 2020 - - The US Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.

In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer, industry, and sometimes a patient representative.

Additional experts with specific expertise may be added for individual meetings as needed.

Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.

In terms of timing of the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.

The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted.

These comments will be reviewed by the FDA.

The FDA intends to livestream the VRBPAC meeting on the agency's YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.