Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Moderna announced that the U.S. Food and Drug Administration (FDA) will initiate the review of its investigational seasonal influenza vaccine submission, mRNA-1010. Following a Type A meeting and a revised regulatory approach, the FDA accepted the biologics license application (BLA) for review, with a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. If approved, mRNA-1010 could be available for U.S. adults 50 years and older for the 2026/2027 flu season.