Moderna's mRNA flu vaccine, mFlusiva, has won FDA approval for adults 50 and older, marking the first mRNA flu shot on the U.S. market.
The FDA granted standard approval for ages 50–64 and accelerated approval for those 65 and older, pending further confirmatory trials.
This approval follows a prior refusal‑to‑file letter in February 2026, when the FDA objected that Moderna’s pivotal trial control group did not reflect the best‑available standard of care; Moderna later amended its application and won unanimous backing from the FDA’s VRBPAC in June 2026.
mFlusiva (mRNA‑1010) is a trivalent vaccine that targets influenza A/H1N1, A/H3N2, and B/Victoria; large phase 3 trials showed it outperformed a standard‑dose flu shot in adults 50+.
Moderna plans U.S. rollout this fall, aiming to position mFlusiva and a planned COVID‑flu combination shot as key revenue drivers going into the next decade.
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