The Food and Drug Administration has granted approval for Moderna’s mRNA-based influenza vaccine, designated mFLUSIVA, for administration to individuals aged 50 and older. The company announced the authorization late Wednesday and stated the vaccine will reach the market in a few weeks, positioning it for availability during the 2026-2027 respiratory virus season in the United States. This represents the first approved seasonal flu vaccine utilizing messenger RNA technology, the same platform employed in COVID-19 immunizations.
According to Moderna, clinical research involving more than 40,000 participants demonstrated that mFLUSIVA is safe and generates stronger protective immune response compared to conventional flu vaccines. The company’s leadership framed the approval as validation of the mRNA platform’s adaptability across multiple disease applications and emphasized the vaccine’s potential to address public health needs among older Americans.
The regulatory approval drew significant attention given the current administration’s complicated relationship with mRNA technology. While President Trump’s administration initially embraced mRNA vaccines during his previous term, subsequent public backlash against pandemic policies and vaccine mandates contributed to negative perceptions of the technology. The administration has since reduced funding for mRNA research and restricted COVID vaccine access. Secretary of Health and Human Services Robert F. Kennedy Jr., known for his vaccine skepticism, has vocally opposed mRNA vaccines.
The FDA had originally declined to review Moderna’s flu vaccine application but reversed course following pressure from pharmaceutical industry representatives and public health professionals. An independent advisory panel convened in June unanimously recommended approval. Public health experts highlighted advantages of mRNA technology, including the capability to update and manufacture vaccines more rapidly than traditional approaches, potentially enabling faster responses to emerging flu strains or pandemic threats.
Public health officials expressed support for the development. However, vaccine critics opposed the decision, with some expressing concerns about the relative novelty of the platform and calling for more extensive study of long-term implications.
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