FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.
“The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to address the general development of COVID-19 vaccines on October 22nd. The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible. A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure. It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”
The meeting will be held on Oct. 22, 2020, from 10:00 a.m. ET to 5:00 p.m. ET via webcast. The FDA intends to make background material available to the public, including the meeting agenda and Committee roster, no later than two business days before the meeting. In general, advisory committees include a Chair, several members, plus a consumer, industry and sometimes a patient representative. Additional experts with special knowledge may be added for individual meetings as needed. Although the committees provide advice to the agency, final decisions are made by the FDA.