For immediate release:

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biologics Advisory Committee (VRBPAC) on December 10 to discuss the Emergency Use Authorization (EUA) application for a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

“The FDA recognizes that transparency and dialogue are essential for building public confidence in COVID-19 vaccines. I want to assure the American people that the FDA process and data assessment for a potential COVID-19 vaccine will be as open and transparent as possible, ”said FDA Commissioner Stephen M. Hahn, MD. FDA has been preparing for the EUA review for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA application is submitted. While we cannot predict how long the FDA review will take, the FDA will review the request as quickly as possible, while always doing so in a thorough and scientific manner, so that we can help make a vaccine available that the American people deserve. As soon as possible. A discussion on the safety and efficacy of the Pfizer and BioNTech vaccine with this committee, made up of outside scientific and public health experts from across the country, will help ensure a clear public understanding of the scientific data and information that the FDA will assess in order to decide whether or not to authorize a vaccine for emergency use for the prevention of COVID-19. “

The FDA intends to make background materials, including the meeting agenda and list of committees, publicly available no later than two business days prior to the meeting. Typically, 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 can be added for one-on-one meetings, if required.

Although VRBPAC members provide advice to the agency, which may include advice on safety and efficacy data submitted in the EUA application, final decisions on whether or not to authorize the vaccine for use in emergency are taken by the FDA. In terms of the schedule of the VRBPAC meeting after submission of the EUA application, this time frame will allow the FDA to thoroughly assess the data and information submitted in the EUA application prior to the meeting and prepare for an in-depth public discussion with the members of the advisory committee.

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

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

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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