mFLUSIVA became the first mRNA-based influenza shot cleared anywhere in the world, with accelerated approval for adults 65 and older tied to post-market studies.
Moderna said the U.S. Food and Drug Administration (FDA) (U.S. drug regulator) has authorized mFLUSIVA, also known as mRNA-1010, for adults aged 50 and older, marking the first approval of an mRNA-based influenza vaccine anywhere in the world. The decision extends Moderna's mRNA platform beyond COVID-19 and respiratory syncytial virus (RSV) into flu and gives the company four FDA-authorized products in the United States and five globally. Approval terms differ by age: adults aged 50 to 64 received a standard license, while those 65 and older received accelerated approval that requires confirmatory post-market studies. Moderna said it must run follow-up research involving about 800,000 participants over two flu seasons to show clinical efficacy in the older population. The authorization was backed by trials including a 40,805-person study across 11 countries in adults aged 50 to 64 and a separate U.S. immunogenicity study in 2,992 adults aged 65 and older. The company said no new safety concerns were identified. The clearance follows a turbulent review after the FDA issued a refusal-to-file letter in February over the comparator vaccine used in trials, a dispute that later widened into a broader political debate around mRNA vaccines. That uncertainty eased in June when the FDA's Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend approval. Moderna plans to begin supplying mFLUSIVA through select U.S. retail channels in the 2026-2027 winter season while pursuing regulatory processes in the European Union, Canada and Australia. The launch could challenge a flu vaccine market led by Sanofi, GSK, CSL Seqirus and AstraZeneca, though Moderna has already missed major purchasing contracts for the 2026 season and meaningful revenue is therefore expected only in the second half of 2027. Jefferies estimates U.S. sales of about $750 million by 2030 for the standalone flu shot and a COVID-flu combination vaccine together.