FDA opens review of Moderna mRNA-1010 flu vaccine filingFebruary 20, 2026 FDA will review Moderna’s amended application for its mRNA-1010 seasonal flu vaccine, with an Aug. 5, 2026 goal date for an agency decision.
FDA declines to review Moderna mRNA flu vaccine filingFebruary 13, 2026 FDA declined to accept Moderna’s mRNA-1010 flu vaccine application for review, citing trial comparator concerns, and Moderna requested a Type A meeting with FDA.