Moderna Gains FDA Review for Flu Vaccine, Sets August 5, 2026 PDUFA Date
Moderna’s biologics license application for mRNA-1010 will proceed to FDA review with an August 5, 2026 PDUFA goal date for adults 50+. The reversal following last week’s refusal-to-file sets the stage for potential approvals in the U.S., Europe, Canada and Australia in 2026.
1. FDA Reversal and Application Acceptance
After a Type A meeting, FDA reversed its prior refusal-to-file decision and accepted Moderna’s biologics license application for the investigational mRNA-1010 influenza vaccine. This acceptance signals the start of formal regulatory evaluation in the U.S.
2. PDUFA Date and Approval Strategy
The FDA assigned an August 5, 2026 PDUFA goal date for mRNA-1010 review targeting adults aged 50 and older. Moderna is seeking full approval for those 50–64 and accelerated approval for adults 65+, with a post-marketing study requirement for older cohorts.
3. Global Submission Footprint and Next Steps
Moderna’s vaccine application has also been accepted for review in Europe, Canada and Australia, and additional regional filings are planned in 2026. Pending successful evaluations, mRNA-1010 could be available for the 2026/2027 flu season in multiple markets.