A key FDA hurdle cleared Thursday as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously that Moderna’s seasonal mRNA flu vaccine, mRNA-1010 (seeking brand name Mflusiva), has benefits that outweigh risks for adults aged 50 to 64 and separately for adults aged 65 and older. Panelists’ recommendation keeps Moderna’s regulatory turnaround on track after earlier FDA friction over whether the BLA should be accepted. The company is seeking standard approval in the 50-to-64 group and accelerated approval for the 65-and-older population, with an FDA decision expected by Aug. 5. During the meeting, staff presentations characterized the evidence as meeting sufficient hurdles for a traditional pathway in the younger cohort and for an accelerated pathway in the older cohort. The vote also followed outside discussion during public comment by former FDA employee Wellington Sun, a point underscoring the political sensitivity around vaccine regulatory decisions. If FDA follows the panel’s advice, mRNA-1010 would expand the set of mRNA-enabled options for seasonal influenza and potentially strengthen U.S. preparedness for emerging strains or pandemic-like threats.
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