Moderna (NASDAQ:MRNA) announced on Thursday that the U.S. Food and Drug Administration has approved its influenza vaccine, mFLUSIVA, for adults aged 50 and over. The decision marks the company’s first mRNA-based flu vaccine and the fourth product from Moderna to receive FDA approval.
The biotechnology group expects to begin distributing mFLUSIVA to selected U.S. retailers over the coming weeks, ahead of the 2026-2027 respiratory virus season. Worldwide, the approval makes mFLUSIVA Moderna’s fifth authorised product.
Approval supported by global Phase 3 trial
The FDA’s decision follows a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee and is backed by results from a Phase 3 clinical trial involving 40,805 adults aged 50 and older across 11 countries.
For adults aged 65 and above, the vaccine received accelerated approval based on immune response data from a separate U.S. study involving 2,992 participants. Moderna said it will carry out post-marketing confirmatory studies to verify the vaccine’s clinical benefit in older adults.
The company added that its Phase 3 development programme demonstrated an acceptable safety profile and identified no new safety concerns.
Moderna expands global regulatory submissions
Chief Executive Stéphane Bancel said Moderna’s mRNA platform offers an additional vaccination option for older adults, who remain at greater risk of developing severe complications from influenza.
The company also confirmed that regulatory reviews of mFLUSIVA are currently underway in the European Union, Canada and Australia, with further regulatory submissions planned before the end of the year.
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