The FDA has approved Moderna’s mRNA seasonal influenza vaccine mFLUSIVA for adults aged 50 and older, adding a new mRNA option to the US flu vaccine market.

FDA approval covers adults aged 50 and older

The approval of mFLUSIVA, also known as mRNA-1010, was supported by data from a Phase 3 trial involving more than 40,000 adults aged 50 and older.

The study evaluated the vaccine’s safety, reactogenicity and relative vaccine efficacy against an active comparator.

Moderna said mFLUSIVA was 26.6% more efficacious than the comparator, meeting criteria for non-inferiority, superiority and higher-level superiority.

The most common adverse events were injection site pain, fatigue, headache and myalgia, and were reported more frequently among people receiving mFLUSIVA than the active comparator.

The approval makes mFLUSIVA the first mRNA seasonal influenza vaccine approved by the FDA for use in adults aged 50 and older.

mRNA technology could shorten flu vaccine production

One potential advantage of mRNA technology is the speed at which vaccines can be produced after influenza strains have been selected.

Traditional seasonal influenza vaccines, including egg-based, cell-based and recombinant vaccines, can take several months to move from strain selection to availability.

Moderna has previously said its mRNA manufacturing process could reduce this period to around two to three months, compared with approximately six months for traditional seasonal flu vaccines.

A shorter production timeline could allow vaccines to be manufactured closer to the beginning of flu season, potentially improving the match between the vaccine and circulating influenza strains.

GlobalData infectious disease analyst Stephanie Kurdach said: “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.”

The potential to respond more quickly to changes in circulating influenza viruses is particularly relevant because seasonal flu vaccine composition must be determined before the full characteristics of the viruses circulating during the upcoming season are known.

Moderna plans 2026-2027 flu season launch

Moderna expects mFLUSIVA to be available for older adults in time for the 2026-2027 influenza season.

The company is also seeking regulatory decisions for the vaccine in Europe, Canada and Australia, with additional submissions planned during 2026.

The FDA approval follows Moderna’s expansion of its mRNA vaccine portfolio beyond COVID-19 and into seasonal respiratory diseases.

The company’s combined influenza and COVID-19 vaccine mCOMBRIAX was approved by the European Commission in April 2026 for adults aged 50 and older.

Additional analyses, including a confirmatory trial, are required for continued approval of mFLUSIVA in adults aged 65 and older.

For the wider influenza vaccine market, the approval provides Moderna with an opportunity to compete with established egg-based, cell-based and recombinant vaccine technologies while testing whether the advantages of mRNA manufacturing and vaccine performance translate into greater uptake.