FDA vaccine advisers have voted unanimously in favor of Moderna’s seasonal mRNA-1010 influenza vaccine, clearing a key hurdle as the company seeks to expand its mRNA platform to the flu market. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) backed the vaccine’s benefit-risk profile in adults aged 50 to 64 and also supported the same conclusion for adults 65 and older. Moderna is pursuing standard approval for the 50-to-64 group and accelerated approval for the older cohort. A decision is expected by Aug. 5. The company’s review momentum follows an earlier FDA refusal-to-file step, and the advisory vote now places the product back on a faster track. Panelists pointed to the robustness and clarity of the presented studies, with committee members also noting the potential for better preparedness against emerging or pandemic influenza strains.
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