On July 30, 2025, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s investigational mRNA influenza vaccine, mRNA-1010 (proposed brand name mFlusiva), outweigh its risks for adults ages 50 to 64 and adults ages 65 and older. mRNA-1010 is a seasonal influenza vaccine developed using Moderna’s mRNA platform.
According to Moderna, the committee’s vote was supported in part by data from the company’s Phase 3 clinical program, including the pivotal Phase 3 trial (NCT06602024), which enrolled more than 40,000 participants. Moderna reported that the study demonstrated mRNA-1010 was superior to licensed standard-dose influenza vaccines in preventing RT-PCR-confirmed, protocol-defined influenza-like illness in adults age 50 and older.
The FDA will consider VRBPAC’s recommendation as part of its review of Moderna’s Biologics License Application for mRNA-1010. mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada, and Australia. Moderna has received a Prescription Drug User Fee Act goal date of August 5, 2026. According to Moderna, regulatory submissions in additional countries are planned during 2026.