USA – FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.

In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine development and review, members of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) were tasked with reviewing FDA’s guidance, considering ethical issues surrounding the unblinding of Phase 3 clinical trials if a vaccine is authorized under an EUA and recommending studies needed to evaluate vaccines for safety and efficacy in the postmarket setting.
The much-awaited meeting, which was scheduled in August, follows the issuance of FDA’s guidance on COVID-19 vaccine development and licensure and the recent tussle between the agency and the White House over stricter guidelines for issuing an EUA for a vaccine. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness thresholdRegulatory Focus 30 June 2020; FDA issues COVID-19 vaccine EUA guidance after clash with White HouseRegulatory Focus 6 October 2020)…