Nov 30, 2020, 19:08 ET
SILVER SPRING, Md., Nov. 30, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
"In keeping with the FDA's commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission," said FDA Commissioner Stephen M. Hahn, M.D. "The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves."
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 FDA intends to issue a Federal Register notice as soon as possible 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.
- COVID-19 Vaccines
- Emergency Use Authorization for Vaccines Explained
- Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
- Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
- Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement
Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: [email protected], 888-INFO-FDA
The FDA, an agency within the U.S. 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.
SOURCE U.S. Food and Drug Administration
Share this article