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US FDA COVID-19 Adcom: What Additional Members Are Needed?

 
• By Derrick Gingery

Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application. 

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An ethics expert may be among those needed for the FDA's VRBPAC review of a coronavirus vaccine application. • Source: File photo

When the US Food and Drug Administration convenes the high-profile advisory committee review of the first coronavirus vaccine, a diverse mix of experts, including some from outside the core vaccine and infectious disease specialties, could help decide an approval recommendation. Choosing the best experts may be a key factor in the agency's effort to ensure that the data and potential application questions are fully vetted and ensure public confidence in the evaluation.

As several coronavirus vaccine candidates have started or are nearing Phase III clinical trials, attention has shifted to the FDA’s plans for assessing any applications that may arrive. The agency...

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