FDA Panel Unanimously Recommends Moderna's mRNA Flu Vaccine mFlusiva
FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine mFlusiva for adults 50 and over, the committee's first new vaccine review since 2023. The FDA expects an approval decision by Aug 5, 2026.
The Food and Drug Administration's top vaccine advisory committee voted unanimously to recommend Moderna's mRNA influenza vaccine, mFlusiva, for adults 50 and over. The vote by the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, is a step towards what may be the first vaccine filed and approved under the second Trump administration, despite sustained criticism of vaccines from the President and the Health and Human Services Secretary. Last year, the Secretary pulled back almost $500 million in contracts to develop mRNA vaccines.
The FDA declined in February to review Moderna's application for the mRNA flu vaccine, then reversed its decision two weeks later after criticism. The FDA expects to make a decision on approval by 5 August 2026; if approved, the vaccine would be available to adults in the United States 50 and over.
Messenger-RNA, or mRNA, provides instructions for the body to produce flu antigens to develop immunity. Moderna's mRNA flu vaccine includes microscopic doses of mRNA for three to four strains of the flu — totaling about the same weight that a fingerprint leaves on a mirror. Many public health and infectious disease experts are excited about the shot because mRNA vaccines can be produced much more reliably and quickly — and potentially faster than traditional flu vaccines. That could make the mRNA vaccine far more effective when a new flu strain suddenly emerges. Moderna and the FDA did not find credible safety risks in the review. Moderna wrote in its brief that the vaccine "does not enter the cellular nucleus, does not interact with the genome … and does not persist in the body."
Results from Moderna's phase 3 trial were published in the New England Journal of Medicine and Nature Immunology. Researchers examined the vaccine response from 75 patients in the trial in detail and found that the mRNA vaccine produced a longer-lasting response and antibodies that recognized more flu strains, which could explain why the mRNA vaccine may be better than today's flu vaccines. A VRBPAC member noted that phase 3 efficacy studies were conducted in tens of thousands of individuals and that over 6 billion doses of mRNA vaccines have been administered since 2020, with an "incredibly safe safety profile" and no risk of DNA integration.
CDC data presented at the meeting showed at least 32 million flu cases, 390,000 hospitalizations, and 24,000 deaths in the U.S. in the 2025-2026 flu season, and approximately 85% of those eligible for vaccination were not fully vaccinated against influenza. Moderna's vice president of epidemiology acknowledged flu prevalence and highlighted the issue of strain mismatch with current vaccines.