Moderna mRNA Flu Vaccine Approval Wins FDA Nod

Moderna, Inc. received U.S. Food and Drug Administration approval on August 5, 2026, for mFLUSIVA (mRNA‑1010), the first FDA-approved mRNA seasonal influenza vaccine. The vaccine is authorized for adults 50 and older, with full approval for ages 50–64 and accelerated approval for those 65 and above, contingent on confirmatory post-marketing data.

FDA Grants Split Approval

The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended mFLUSIVA in June, concluding a roughly seven-month review that began with an initial refusal to accept Moderna’s application in February. Moderna proposed a staggered approval approach during the review, which the agency adopted. The accelerated approval for adults 65 and older requires a Phase 4 post-marketing confirmatory study, and the FDA may modify or withdraw this indication if the trial does not confirm benefit. Moderna CEO Stéphane Bancel said, “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors.”

Trial Results and Rollout

The approval is based on a randomized, observer-blind, active-controlled Phase 3 trial (ClinicalTrials.gov NCT06602024) that enrolled 40,805 adults aged 50 and older across 11 countries. Late-stage data showed mFLUSIVA was about 26.6% more effective than a licensed standard-dose flu vaccine in preventing laboratory-confirmed influenza. Participants aged 50–64 were roughly 27% less likely to contract influenza during at least one season compared with the comparator.

The Phase 3 program demonstrated an acceptable safety profile with no new concerns. Injection-site pain, fatigue, and headache occurred more frequently than with standard vaccines but were generally mild to moderate and lasted one to two days.

For adults 65 and older, accelerated approval was based on a separate randomized study (ClinicalTrials.gov NCT05827978) involving 2,992 U.S. participants. The FDA’s decision for this group relied on stronger antibody responses compared with a high-dose flu vaccine used in older adults, rather than direct clinical efficacy endpoints.

Moderna expects U.S. supply to reach select retailers within weeks and plans to offer mFLUSIVA for eligible adults during the 2026–2027 respiratory virus season. The vaccine will join Moderna’s respiratory portfolio alongside Spikevax, mRESVIA, and mNEXSPIKE. This marks Moderna’s fifth approved product globally and its fourth FDA-approved vaccine marketed in the United States. Regulatory filings are under review in the European Union, Canada, and Australia.

mFLUSIVA uses mRNA to deliver a blueprint for influenza surface proteins, prompting cells to produce antigens that trigger an immune response. This sequence-based design could allow faster updates to vaccine strains than traditional egg- or cell-based production, potentially accelerating regulatory pathways for future pandemic mRNA flu vaccines.