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US FDA Clarifies: Coronavirus Vaccine Will Need Adcom Before Approval Decision

 
• By Derrick Gingery

In a JAMA article, senior FDA leaders state that the outside advisers will be needed to ensure transparency given the potentially widespread use of the vaccine.

FDA Advisory Committee Feature image
The JAMA article was published after FDA and other administration officials made less than definitive statements about whether an advisory committee would be convened.

An advisory committee will be convened before a coronavirus vaccine receives an emergency use authorization or full licensure, the US Food and Drug Administration said, attempting to resolve questions about whether outside experts will opine on the clinical data and other issues before the product is made available.

In a Journal of the American Medical Association article published on 7 August, Anand Shah, FDA deputy commissioner for medical and scientific affairs; Peter Marks, director of the Center for Biologics Evaluation and Research; and commissioner Stephen Hahn wrote that an EUA or full licensure are possible for a coronavirus vaccine

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