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Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA

$MRNAPress releaseAug 5, 2026, 10:15 PM ETRead the release

Moderna secured FDA approval for mFLUSIVA, the first mRNA-based seasonal influenza vaccine, for use in adults 50 years of age and older. The approval for adults 50-64 was based on a Phase 3 trial of 40,805 participants, while the indication for those 65 and older received accelerated approval based on immunogenicity data.

Key figures

Drug Name
mFLUSIVA (mRNA-1010)
Phase Of Trial
Phase 3
Phase 3 enrollment
40805
Accelerated approval enrollment
2992

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