WASHINGTON — A U.S. Food and Drug Administration advisory panel has recommended approval of Moderna’s mRNA-based seasonal influenza vaccine, marking a step toward potential authorization of the first U.S. flu vaccine developed using messenger RNA technology. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, known as mFlusiva or mRNA-1010, outweigh its risks for adults aged 50 and older.
The recommendation is not a final approval. The FDA will make the final regulatory decision, with a decision deadline set for August 5, 2026, according to regulatory information.
The panel’s vote followed a review of clinical trial data submitted by Moderna, including studies evaluating immune responses and effectiveness compared with existing influenza vaccines. A Phase 3 trial involving more than 40,000 adults aged 50 and older showed the vaccine provided a higher level of protection against seasonal influenza compared with a standard flu vaccine, according to data presented to advisers.
For adults aged 65 and older, the company presented data showing the vaccine generated stronger immune responses compared with a high-dose influenza vaccine used for that age group. The advisory committee also reviewed safety findings and did not identify major safety concerns in the data presented.
The vaccine uses the same mRNA platform that was deployed in COVID-19 vaccines and is designed to instruct cells to produce flu-related proteins that stimulate an immune response. Moderna has argued that the technology could allow faster updates and manufacturing compared with traditional influenza vaccine production methods.
The recommendation comes after an earlier regulatory setback. The FDA initially declined to review Moderna’s application in February, citing concerns about the design of the company’s clinical studies, but later agreed to review the submission after additional discussions.
Moderna said it welcomed the advisory committee’s review. “We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010,” Moderna Chief Executive Stéphane Bancel said in a company statement following the vote.
If approved, mFlusiva would become the first seasonal influenza vaccine based on mRNA technology licensed in the United States. The vaccine would still require additional public health recommendations before broader use, including consideration by the Centers for Disease Control and Prevention’s advisory process.
The FDA’s final decision on the application remains the next confirmed regulatory step.
