Key Takeaways:
Moderna won U.S. FDA approval for mFLUSIVA, its mRNA flu vaccine, for adults 50 and older — the first mRNA flu shot cleared in the country.
"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," Stéphane Bancel, chief executive officer of Moderna, said.
Approval in adults 50 through 64 rests on a randomized, observer-blind Phase 3 trial (NCT06602024) that enrolled 40,805 adults across 11 countries, evaluating relative vaccine efficacy against a standard-dose comparator. Use in adults 65 and older was granted accelerated approval based on immunogenicity data from a separate trial (NCT05827978) of 2,992 adults, with clinical benefit to be confirmed in a postmarketing study. The Phase 3 program showed an acceptable safety profile with no new safety concerns identified.
mFLUSIVA is Moderna's fifth approved product globally and fourth cleared by the FDA, adding a seasonal revenue stream beyond its COVID franchise. The company expects supply at select U.S. retailers in the coming weeks for the 2026-2027 respiratory season, alongside Spikevax, mRESVIA and mNEXSPIKE.
Regulatory reviews are underway in the European Union, Canada and Australia, with submissions in additional countries planned during 2026. The approval follows a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee. Moderna shares traded near $54.82, down 5.4 percent on Aug. 1, though up 98.6 percent over the past year, according to Simply Wall St data.
The approval diversifies Moderna's revenue beyond COVID-19, where demand has faded, and gives the company a foothold in a seasonal flu market dominated by Sanofi, GlaxoSmithKline and CSL. Investors will watch 2026-2027 season uptake and the postmarketing trial confirming benefit in adults 65 and older, whose indication carries accelerated-approval status.
This article is for informational purposes only and does not constitute investment advice.
