The FDA has approved Moderna’s mRNA seasonal influenza vaccine, mFLUSIVA (mRNA-1010), for the prevention of seasonal influenza in adults 50 years of age and older. mFLUSIVA is now the first and only mRNA seasonal influenza vaccine on the market*, marking a major advancement for the field. The approval is expected to cement Moderna’s position in the seasonal influenza vaccines market, says GlobalData, a leading intelligence and productivity platform.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “This is a significant advancement for the seasonal influenza vaccines market, as the utilization of mRNA technology in influenza vaccines will improve vaccine effectiveness.”

Influenza vaccines produced using mRNA technology will have a shorter production time than seasonal influenza vaccines currently on the market including egg-based vaccines, cell-based vaccines, and recombinant vaccines. According to Moderna, while traditional seasonal influenza vaccines can take approximately six months from strain selection to launch, its vaccine takes only two to three months. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains.

Kurdach continues: “One of the most prominent unmet needs in preventing seasonal influenza infections is enhanced vaccine effectiveness, and the utilization of mRNA technology has the potential to fulfil this unmet need.”

mFLUSIVA’s FDA approval was supported by data from the pivotal Phase III trial, which evaluated the safety, reactogenicity, and relative vaccine efficacy of mFLUSIVA versus an active comparator vaccine in over 40,000 adults aged 50 years and older. The most common adverse events were injection site pain, fatigue, headache, and myalgia, and were observed more frequently in the mFLUSIVA group versus the active comparator group.

However, the mRNA vaccine was evaluated as being 26.6% more efficacious than the active comparator, which met the criteria for noninferiority, superiority, and higher-level superiority. Additional analyses, including a confirmatory trial, are still necessary for the continued approval of the vaccine in adults aged 65 years and older.

Moderna has announced that it expects to have mFLUSIVA available for older adults in time for the 2026-2027 influenza season. mFLUSIVA is also pending regulatory decisions in Europe, Canada, and Australia, with further submissions planned throughout 2026.  

Kurdach concludes: “As uptake of mFLUSIVA increases, due to its increased effectiveness, the market share of existing influenza vaccines is expected to decrease, with Moderna becoming established as a key player in the seasonal influenza vaccines field. Moderna is already a leader in the mRNA vaccines space. According to GlobalData, of the 27 approved mRNA vaccines globally, the majority are Moderna’s assets.”

*Moderna’s influenza/COVID-19 combined mRNA vaccine mCOMBRIAX (mRNA-1083) was also approved by the European Commission in April this year for adults 50 years of age and older.