FDA Approves Moderna’s mRNA Flu Vaccine for Adults 50 and Older
The FDA has approved Moderna's mRNA seasonal flu vaccine, mFLUSIVA, for individuals aged 50 and older, with availability anticipated for the 2026-2027 respiratory illness season.
Chicago, IL, August 6, 2026 —
The U.S. Food and Drug Administration (FDA) has approved Moderna’s messenger RNA (mRNA) based seasonal flu vaccine, mFLUSIVA. The vaccine is indicated for use in individuals aged 50 years and older.
Moderna’s mFLUSIVA utilizes mRNA technology, similar to that used in some COVID-19 vaccines, to stimulate an immune response against influenza viruses. This marks a significant development in flu prevention, as it is one of the first mRNA-based flu vaccines to receive FDA approval.
Availability of the mFLUSIVA vaccine is expected to begin for the 2026-2027 respiratory illness season. Further details regarding distribution and specific launch timelines will be announced by the company.
The approval is based on clinical trials that evaluated the safety and efficacy of the mFLUSIVA vaccine in the target population. Details from these trials, including specific efficacy rates and safety profiles, were part of the submission to the FDA.
This new vaccine option aims to provide a different approach to seasonal influenza vaccination, potentially offering enhanced or alternative immune responses compared to traditional flu vaccines. The FDA’s review process involved a thorough examination of the scientific data to ensure the vaccine meets the agency’s standards for safety and effectiveness.
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