CAMBRIDGE, Mass., Aug. 5, 2026

Moderna, Inc. has received U.S. Food and Drug Administration (FDA) approval for mFLUSIVA® (mRNA-1010), the first mRNA-based seasonal influenza vaccine, for adults 50 years of age and older. The approval marks Moderna’s fifth approved product globally and fourth FDA-approved product, further expanding its portfolio of mRNA-based vaccines. The company expects mFLUSIVA to become available through select U.S. retailers in the coming weeks for the 2026–2027 influenza season, joining Spikevax®, mRESVIA®, and mNEXSPIKE® in Moderna’s respiratory vaccine portfolio. The approval follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), highlighting confidence in the vaccine’s clinical data and safety profile.

Phase 3 Clinical Trial Demonstrated Safety and Effectiveness

The FDA approval for adults 50 to 64 years of age is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial involving 40,805 participants across 11 countries. The study evaluated the relative vaccine efficacy (rVE) of mFLUSIVA compared with a standard-dose influenza vaccine in preventing RT-PCR-confirmed influenza-like illness caused by both influenza A and B viruses, while also assessing safety and reactogenicity. Approval for adults 65 years and older was granted under the FDA’s accelerated approval pathway, based on immunogenicity data from a separate randomized clinical trial involving 2,992 participants in the United States. Continued approval in this age group will depend on confirmation of clinical benefit through a required post-marketing clinical trial.

mRNA Platform Continues to Expand Beyond COVID-19

According to Moderna, mFLUSIVA represents another milestone demonstrating the versatility of its mRNA technology platform beyond COVID-19 vaccines. The vaccine is designed to provide active immunization against seasonal influenza A and B virus strains included in the annual vaccine formulation. Clinical studies demonstrated an acceptable safety profile, with no new safety concerns identified. The most frequently reported adverse events included injection-site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, fever, and temporary swelling of lymph nodes, findings consistent with previous clinical evaluations. The approval further strengthens Moderna’s strategy of developing innovative mRNA-based vaccines targeting major respiratory infectious diseases.

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Moderna Strengthens Global Respiratory Vaccine Portfolio

With FDA approval secured, Moderna is advancing the global commercialization of mFLUSIVA, while regulatory reviews are currently underway in the European Union, Canada, and Australia, with additional international submissions planned throughout 2026. The approval reinforces Moderna’s leadership in mRNA medicine, supporting its broader pipeline spanning infectious diseases, oncology, and rare diseases. As seasonal influenza continues to pose a significant public health burden among older adults, mFLUSIVA provides a new preventive option for individuals aged 50 years and above while further establishing Moderna’s position as a leading innovator in next-generation vaccine development.

Source:Moderna press release