FDA approves Moderna's mFLUSIVA, the first US mRNA flu vaccine, for adults 50 and older

The FDA approved mFLUSIVA (mRNA-1010), Moderna's seasonal flu vaccine, for adults 50 and older. Adults 50 to 64 received full approval based on a Phase 3 trial against a standard-dose vaccine, while adults 65 and older received accelerated approval that requires a confirmatory study. It is Moderna's fourth FDA-approved product and fifth approved worldwide, and it is the company's main near-term launch for the 2026-2027 season.

• Approved for adults 50 and older
• Adults 50 to 64: full approval; adults 65 and older: accelerated approval
• Fourth FDA-approved Moderna product; fifth approved globally
• Supply expected at select retailers in the coming weeks