FDA Advisory Committee Votes in Favor of Moderna Flu Vaccine Benefit-Risk Profile
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.
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