Beyond COVID: Moderna Wins FDA Approval for Its Seasonal Flu Vaccine

The U.S. Food and Drug Administration (FDA) on Wednesday approved Moderna Inc.’s (NASDAQ:MRNA) mFLUSIVA (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older.

The approval follows unanimous recommendations from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mFLUSIVA for adults 50 years of age and older.

Phase 3 Trials Validate Efficacy

The standard approval for adults between the ages of 50 and 64 stems from an active-controlled, Phase 3 trial that enrolled 40,805 participants.

Researchers primarily evaluated the vaccine’s safety, reactogenicity, and relative efficacy against a standard-dose comparator in preventing laboratory-confirmed influenza-like illnesses caused by either A or B strains.

Accelerated FDA Clearance For Seniors

For adults 65 years and older, the agency granted accelerated approval based on a separate Phase 3 study involving 2,992 U.S. seniors.

The specific trial measured mFLUSIVA’s immunogenicity against a high-dose inactivated flu vaccine.

While broader analyses support its effectiveness, a postmarketing trial will be conducted to confirm the clinical benefit for this older population. Throughout the Phase 3 program, the vaccine maintained an acceptable safety profile consistent with previous studies, identifying no new safety concerns.

Future Market Rollout And Global Expansion

Moderna anticipates making mFLUSIVA available to eligible U.S. patients in time for the 2026-2027 respiratory virus season.

The flu shot will be offered alongside the company’s existing respiratory lineup, including Spikevax, mRESVIA, and mNEXSPIKE.

Internationally, the vaccine is currently under regulatory review in the European Union, Canada, and Australia, with additional international submissions scheduled throughout 2026.

On Tuesday, Moderna initiated a Phase 1 trial evaluating mRNA-1469, an investigational vaccine designed to prevent Bundibugyo ebolavirus disease, for which no licensed vaccines currently exist.

The study is being conducted in Canada as part of a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to $50 million to support preclinical testing and the Phase 1 trial.

MRNA Price Action: Moderna shares were down 1.86% at $55.21 at the time of publication on Thursday, according to Benzinga Pro data.

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