But agency wants discussion on considerations for the selection of a specific JN.1 lineage strain, such as the KP.2 subvariant, for the 2024-2025 formulation. Although JN.1 sublineages were predominant in the spring, KP.2 is now the most prevalent circulating strain in the US.
The US Food and Drug Administration is weighing whether the COVID-19 vaccine formulation for the 2024-2025 season should target the JN.1 variant, as recommended by other international regulators, or whether the KP.2 subvariant that is currently the predominating circulating strain should be the focus.
The Vaccines and Related Biological Products Advisory Committee will meet on 5 June, three weeks later than originally planned, to...
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.
