FDA vaccine advisers endorsed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, voting unanimously that benefits outweigh risks for both adults aged 50 to 64 and those 65 and older. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) supported the standard approval pathway for the younger group and an accelerated pathway for older adults. The move follows earlier controversy in which a top FDA official briefly refused to even consider the application for review. Moderna is seeking approval under PDUFA timing that centers on an Aug. 5 decision, with panelists pointing to robust, well-controlled data. Panelists also discussed how accelerated pathways have been used historically for other influenza vaccines, and noted that multiple current products were licensed using similar frameworks. Analysts will now watch whether FDA follows the unanimous advice as the regulator weighs the final benefit-risk assessment. Moderna’s mRNA-1010 program is designed to leverage rapid manufacturing and potential for updating strain match, adding to the company’s broader bet that mRNA platforms can extend beyond COVID-19 into recurring viral seasons.
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