If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.
US Food and Drug Administration advisors voted overwhelmingly in favor of recommending inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines, with most of those in favor of the vaccine update recommending a bivalent product that includes both the prototype vaccine strain and the Omicron sub-lineage BA.4/BA.5 strain.
The Vaccines and Related Biological Products Advisory Committee's 19-2 vote in favor of Omicron boosters on 28 June, combined with...
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.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
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.
