FDA Panel Unanimously Backs Moderna's mRNA Flu Vaccine for Adults 50 and Older

An FDA advisory committee voted unanimously on June 18, 2026, to recommend approval of Moderna's mRNA-based influenza vaccine for adults aged 50 and older, a decision that could reshape how Americans are protected against the flu each year.

The committee, known as VRBPAC, voted 9-0 in favor of the vaccine, called mFlusiva. The FDA is expected to issue a final decision by August 5, 2026.

In a Phase 3 trial involving more than 40,000 participants, mFlusiva showed approximately 27 percent greater efficacy than standard-dose flu shots in preventing influenza-like illness. Against severe outcomes such as hospitalizations, efficacy reached nearly 48 percent.

The vaccine uses the same mRNA technology as COVID-19 vaccines developed by Moderna and Pfizer. One key advantage of the platform is speed: mRNA vaccines can be manufactured in two to three months, compared to the six months required for traditional egg-based flu shots. That faster timeline allows for more accurate strain selection closer to the start of flu season.

The path to approval has not been smooth. In February 2026, the FDA initially refused to file Moderna's application, citing concerns about the trial design for adults 65 and older. After a series of meetings, the agency agreed to review the application under a revised approach, with Moderna seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.

The accelerated approval for older adults comes with a requirement to conduct an additional Phase 4 clinical trial to confirm the vaccine's benefit in that population.

One complicating factor is the disbanding of the CDC's Advisory Committee on Immunization Practices, which normally issues clinical guidelines for vaccine use. Without that body, it remains unclear how mFlusiva will be formally recommended to the public once it reaches the market.