FDA approves Moderna's mFLUSIVA mRNA flu vaccine for adults 50 and older

Moderna

The FDA approved Moderna's mRNA seasonal flu vaccine, mFLUSIVA (mRNA-1010), on August 5, 2026, for adults aged 50 and older. Adults 50 to 64 were approved on the basis of a randomized, observer-blind, active-controlled trial. Adults 65 and older received accelerated approval based on immune responses, with continued approval dependent on a confirmatory study.

• The 50–64 approval rests on a randomized trial of 40,805 adults across 11 countries
• The 65-and-older approval rests on a trial of 2,992 US adults aged 65 and older
• Continued approval for the older group may depend on a postmarketing trial confirming clinical benefit