The US Food and Drug Administration (FDA) approved Moderna's mFLUSIVA (mRNA-1010) for adults aged 50 years and older. According to Moderna, the vaccine is the first mRNA-based influenza vaccine. The company said it expects mFLUSIVA to be available in the US for the 2026 to 2027 respiratory virus season.

FDA approval came after the Vaccines and Related Biological Products Advisory Committee unanimously recommended mFLUSIVA for adults aged 50 years and older.

The agency based its decision for adults aged 50 to 64 years on a randomized, observer-blind, active-controlled phase 3 trial involving 40,805 adults across 11 countries. The trial evaluated safety, reactogenicity, and relative vaccine efficacy compared with a standard-dose influenza vaccine against reverse transcription polymerase chain reaction-confirmed, protocol-defined influenza-like illness caused by influenza A or B.

The FDA granted accelerated approval for adults aged 65 years and older using data from a randomized, observer-blind, active-controlled trial that enrolled 2,992 participants in the US. The primary objective was to evaluate the immunogenicity of mFLUSIVA compared with a high-dose inactivated influenza vaccine. According to Moderna, descriptive analyses of the phase 3 trial also supported vaccine efficacy in adults aged 65 years and older. According to the prescribing information, continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

Moderna described the phase 3 safety findings as acceptable and reported that the program did not identify additional safety concerns. Reported local adverse events included injection-site pain, tenderness, redness, swelling (hardness), and swelling of lymph nodes in the vaccinated arm. Reported systemic adverse events included fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever. The prescribing information states that patients with a history of severe allergic reaction to any ingredient in mFLUSIVA should not receive the vaccine. It also states that severe allergic reactions are rare but can occur following vaccination.

Moderna said authorities in the European Union, Canada, and Australia are reviewing mRNA-1010, and the company plans submissions in additional countries during 2026.

Source: Moderna Inc.