US FDA Adds New Faces To Vaccines Adcomm For Pfizer/BioNTech COVID-19 Review
The Vaccines and Related Biological Products Advisory Committee will have five more members than were present for the 22 October meeting on coronavirus vaccine development and approval issues.
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US COVID-19 Advisors Vexed By Vaccine Post-EUA Placebo Controls, But Agree On Need
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.
COVID-19 Vaccines: Advisory Committee Picks Apart US FDA Guidance On Efficacy Endpoints
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.
Cast Members In US FDA’s COVID-19 Vaccine Advisory Committee
There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.