Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal

The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission for review.

In June, an advisory committee voted unanimously to support the vaccine, and the agency announced approval late on Wednesday. The clearance provides traditional approval for people aged 50 to 64 and accelerated approval for those 65 and older.

mFLUVISA is the first mRNA-based influenza shot cleared in the United States. Moderna says it will make the product available in the coming weeks, ahead of the 2026-2027 respiratory virus season. Pricing has not been disclosed, and analysts expect sales to become a significant growth driver beginning in 2027.