FDA vaccine advisers voted unanimously that the benefits of Moderna’s mRNA-1010 seasonal flu vaccine outweigh the risks for both adults ages 50 to 64 and those 65 and older. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) delivered a 9-0 recommendation for each age group. Moderna is seeking standard approval for the 50-to-64 population and accelerated approval for the older group. The FDA decision is expected by Aug. 5, following a prior controversy in which FDA leadership had briefly refused even to accept the submission for review. Panelists pointed to the strength and clarity of the studies presented at the meeting, with experts noting the vaccine’s potential to improve preparation for emerging or variant influenza strains. The endorsement also drew comparisons to other flu vaccines that were originally licensed via accelerated pathways. While FDA may still diverge from the panel, an unanimous VRBPAC vote materially improves the odds of a successful regulatory path for Moderna’s mRNA expansion beyond COVID-19.
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