The U.S. Food and Drug Administration approved Moderna’s mFlusiva, marking the first authorization of an mRNA vaccine for seasonal influenza. The shot is indicated for adults 50 years and older, with traditional approval for ages 50 to 64 and accelerated approval for adults 65 and older pending confirmatory data.
In a late-stage trial involving more than 40,000 adults 50 and older, mFlusiva demonstrated 26.6% greater efficacy compared with a licensed standard-dose flu vaccine. Separate data showed stronger antibody responses versus a high-dose competitor in the 65-and-older population. Moderna expects the vaccine to be available for the upcoming flu season.
The approval follows a complex regulatory path that included an earlier refusal-to-file notification before the agency reversed course and ultimately received a unanimous recommendation from its advisory committee. Moderna has committed to additional studies to confirm benefit in the older age group.
mFlusiva will compete with established flu vaccines from Sanofi, GSK, CSL Seqirus and AstraZeneca. The mRNA platform offers potential advantages in speed of strain update and manufacturing flexibility, which could prove valuable in seasons with late-emerging variants.
Shares of Moderna responded positively to the news. The approval diversifies the company’s respiratory franchise beyond COVID-19 vaccines and validates continued investment in the mRNA technology platform for additional indications. Commercial execution, pricing, and uptake among older adults will determine the financial contribution in the first full seasons of availability.
Public-health officials continue to emphasize the burden of influenza among seniors. An additional effective option expands the tools available for seasonal vaccination campaigns and may support higher overall coverage rates over time.