A key FDA advisory panel moved Moderna’s seasonal mRNA influenza vaccine forward, voting unanimously that benefits outweigh risks for both adults ages 50–64 and those 65 and older. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) backed the company’s mRNA-1010 (planned brand: Mflusiva/mRNA-1010) despite earlier controversy around the submission. Panelists cited robust and well-conducted study results and said the data support a traditional pathway for younger adults and an accelerated pathway for the older group. VRBPAC’s recommendation, while not binding, typically carries weight in FDA decisions. An FDA decision is expected by Aug. 5, setting up a near-term readout on whether Moderna can complete its regulatory turnaround and restart momentum toward broader adoption of mRNA-based flu vaccination in the U.S.
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