It took little convincing for FDA advisors to support changing COVID-19 vaccines to monovalent XBB formulations, but the committee still isn’t sold on the agency’s annual influenza-like campaign strategy for COVID vaccines and raised several harder calls that FDA and CDC will need to make including when to cut off bivalent shots use and who should get XBB.
US Food and Drug Administration vaccine advisors voted unanimously 15 June to recommend COVID-19 vaccines be updated to a monovalent XBB shots for 2023-2024.
The Vaccines and Biological Products Advisory Committee largely suggested the agency go with either the XBB 1.5 lineage, since that...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
