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COVID-19 Vaccines: Advisory Committee Picks Apart US FDA Guidance On Efficacy Endpoints

 
• By Sue Sutter

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.

VRBPAC photo illustration - general COVID meeting - 22 October 2020
FDA's first advisory committee meeting on COVID-19 vaccines focused on general issues. • Source: YouTube Screenshot

The US Food and Drug Administration's first advisory committee meeting on COVID-19 vaccines revealed that external experts are somewhat dissatisfied with various aspects of the agency’s development advice to vaccine sponsors. However, whether their objections will lead to any substantive change in the agency's path going forward seems unlikely.

At the 22 October meeting of the Vaccines and Related Biological Products Advisory Committee, panel members found plenty to dislike about the agency’s recommendations in the two COVID-19 vaccine guidances issued to date

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