An FDA vaccine advisory committee unanimously backed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010 (Mflusiva), clearing a major regulatory milestone. VRBPAC voted 9-0 that benefits outweigh risks for adults aged 50 to 64 and again 9-0 for adults aged 65 and older. The panel discussion followed a prior refusal-to-file letter earlier this year, after which FDA agreed to review the BLA and set a PDUFA date of Aug. 5. Moderna is seeking traditional approval for the 50-to-64 group and accelerated approval for the older cohort. Company and academic panelists cited what they described as robust clinical data supporting the risk-benefit profile, as the FDA decision moves toward a final agency determination.