The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.
The announcement via the Federal Register and the FDA’s Twitter account comes a day after the head of the key US vaccine research accelerator Operation Warp Speed (OWS) signaled that a COVID-19 vaccine might be authorized or approved by the end of 2020. Both OWS and FDA communications emphasized a continuing commitment to relying on data in vaccine decisions, despite political pressure and medical need for vaccine approval.
A link to the public meeting announcement was posted by the FDA Twitter account on 27 August with a comment that “we will be as open and transparent as possible about our review of a #COVID19 vaccine. Science alone drives the agency’s regulatory decision-making.” The meeting was announced officially in the Federal Register on the same day.
No agenda was available at press time; however, the meeting announcement notes that the advisory committee will meet in open session “to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.” The announcement clarifies that “No specific application will be discussed at this meeting.”…