U.S. FDA approves first mRNA flu shot from Moderna

The U.S. Food and Drug Administration has granted approval for Moderna's first mRNA-based flu vaccine, mFlusiva, for individuals aged 50 and above, the company announced on August 5, 2026. This marks the inaugural approval of an mRNA vaccine for seasonal flu. mFlusiva received traditional approval for adults aged 50 to 64 and accelerated approval for those 65 and older.

Moderna has committed to conducting an additional study and presenting supplementary data in adults 65 and older to substantiate the vaccine's efficacy in this age group. The approval was predicated on data from a late-stage trial involving over 40,000 adults aged 50 and above, which revealed the vaccine was 26.6% more effective than a licensed standard-dose flu vaccine.

The company also submitted separate late-stage data demonstrating that mFlusiva elicited stronger antibody responses than Sanofi's high-dose flu vaccine in adults 65 and older. mFlusiva would vie with flu vaccines produced by Sanofi, GSK, CSL Seqirus, and AstraZeneca. While Moderna anticipates meaningful revenue from the flu vaccine and a potential COVID-flu combination shot only in the second half of 2027, the company relies on these products to offset losses from the COVID vaccine and to demonstrate the enduring commercial viability of its mRNA technology, which has faced resistance from certain U.S. health officials.