An FDA advisory committee voted unanimously in favor of the benefit-risk profile of Moderna's (NASDAQ: MRNA) investigational seasonal influenza vaccine, mRNA-1010, for adults aged 50 and older.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) cast two separate 9-0 votes on June 18, 2026 — one supporting the vaccine's benefit-risk profile for adults aged 50 to 64, and another for adults 65 and older.

The committee's discussion drew on data from Moderna's Phase 3 clinical program, including results from a pivotal trial previously published in The New England Journal of Medicine. The FDA will consider the advisory committee's recommendations as part of its ongoing review of Moderna's Biologics License Application for mRNA-1010, though the recommendations are non-binding.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026, for its final decision. The vaccine has also been accepted for regulatory review in the European Union, Canada, and Australia, with additional country submissions planned during 2026.

"We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," said Stéphane Bancel, Chief Executive Officer of Moderna.

mRNA-1010 is a non-egg-based influenza vaccine candidate. Its observed safety profile in the Phase 3 program was consistent with data from earlier studies of the candidate.