FDA Advisory Panel Unanimously Backs Moderna's mRNA Flu Vaccine mFlusiva
FDA's advisory committee voted 9-0 that Moderna's mRNA flu vaccine mFlusiva benefits outweigh risks for adults 50-64 and 65+, clearing a key hurdle before an Aug. 5, 2026 decision. The FDA initially declined to review the BLA before reversing course.
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously endorsed Moderna's investigational seasonal influenza vaccine mFlusiva (mRNA-1010), voting 9-0 that the vaccine's benefits outweigh its risks for the prevention of influenza disease in adults aged 50-64 and in those aged 65 and older. The vote moves Moderna closer to potential approval ahead of the FDA's Aug. 5, 2026, decision date for the company's biologics license application (BLA).
The advisory committee's review was based on data from Moderna's phase III influenza vaccine program, including results from its pivotal late-stage study that demonstrated the vaccine's potential as a non-egg-based alternative for seasonal flu prevention in older adults. Safety findings discussed during the meeting were consistent with previously reported studies, further supporting the vaccine's regulatory case.
The FDA initially declined to review Moderna's mFlusiva BLA in February due to concerns related to the study design in adults aged 65 years and older. The agency later reversed course after Moderna revised its regulatory strategy for the vaccine based on age. The BLA was subsequently modified to seek traditional approval of mFlusiva in adults aged 50-64 years and accelerated approval for adults aged 65 years and older.
Regulatory reviews are already underway in the United States, the European Union, Canada and Australia, and regulatory submissions in additional countries are planned during 2026. Moderna shares gained 3.5% on Thursday after the committee's endorsement, and the stock is up 116.9% year to date.
The unanimous VRBPAC vote also carries significance for Moderna's broader respiratory vaccine franchise. Moderna withdrew a filing for mCombriax (mRNA-1083), its combination influenza/COVID vaccine, last year after the FDA requested additional efficacy data related to the influenza component. Since mCombriax incorporates the same influenza component used in mFlusiva, the favorable regulatory path for the flu vaccine is viewed as an encouraging signal for the combination vaccine's prospects. Moderna is currently awaiting further FDA guidance regarding a potential future filing for mCombriax, which recently secured approval in the European Union.