FDA reverses course and accepts Moderna's mRNA flu vaccine filing with an August 5 decision date

After a Type A meeting, Moderna proposed splitting the request by age: full approval for adults 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing study. The FDA accepted the biologics license application and set a PDUFA goal date of August 5, 2026. Shares closed roughly 6% higher on the day, according to market reports, and the stock had already risen sharply in 2026.

• FDA accepted the BLA for mRNA-1010 after the earlier refusal to file
• Requested indications: full approval for ages 50 to 64, accelerated approval for 65 and older
• PDUFA goal date: August 5, 2026
• Post-marketing requirement: additional study in older adults
• Filings accepted in Europe, Canada and Australia, with first approvals possible in 2026