US FDA expected to quickly clear the first emergency use authorization for a COVID-19 vaccine following 17-4 VRBPAC vote, but a disorganized committee ending made it unclear why some members voted no. Pediatric data was at issue for at least two voters, though.
The US Food and Drug Administration’s vaccine advisory committee voted 17-4 with one abstention on 10 December in favor of issuing an emergency use authorization for Pfizer Inc. and BioNTech SE’s COVID-19 vaccine in individuals 16 years of age and older, likely guaranteeing the companies a swift and historic authorization.
But the abruptly curtailed meeting, which ended without the typical explanation of each panelist’s vote, left lingering questions about why...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
