The U.S. Food and Drug Administration has approved forbes.com’s mFLUSIVA seasonal influenza vaccine for adults aged 50 and older, marking the country’s first regulatory authorization of an mRNA-based flu shot. According to statnews.com, the agency granted a standard, traditional approval for use in adults aged 50 to 64, alongside an accelerated approval for individuals aged 65 and older.
FDA Approves Moderna mFLUSIVA Vaccine
Moderna announced that the vaccine is expected to be available for eligible populations for the 2026-2027 flu season. Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors. This approval also reflects the ongoing potential of our mRNA platform,
Moderna CEO Stéphane Bancel said in a statement.
Clinical Trial Data and Regulatory Path
The authorization follows a late-stage trial involving nearly 41,000 participants. Data presented to the Food and Drug Administration demonstrated that trial participants aged 50 to 64 who received the mRNA vaccine were approximately 26.6% to 27% more effective at preventing test-confirmed influenza compared to those who received a licensed standard-dose comparator. In June, an independent vaccine advisory committee unanimously recommended approval for that age group.
For the accelerated approval covering adults 65 and older, Moderna has agreed to conduct a Phase 4 post-licensure trial to gather additional effectiveness data. This follow-up research will specifically examine how the mRNA shot compares to existing high-dose or adjuvanted vaccines that are preferentially recommended for older populations in the United States. Additionally, the company submitted separate late-stage data indicating that its vaccine generated stronger antibody responses than Sanofi’s high-dose flu vaccine in adults aged 65 and older.
Technology and Commercial Outlook
Traditional seasonal flu vaccines are largely egg-based or cell-based and contain viral proteins. In contrast, Moderna’s mFLUSIVA uses messenger RNA technology to instruct the body to produce influenza antigens and trigger an immune response—an approach experts note could potentially enable faster manufacturing updates to match circulating viral strains.
Despite the milestone authorization, financial analysts do not expect mFLUSIVA to generate immediate meaningful revenue, noting that Moderna missed the primary contracting cycle for the 2026 U.S. flu season. Jefferies analysts previously projected $750 million in U.S. sales for the company’s standalone flu shot and a future combination COVID-flu vaccine by 2030. The company views the approval as a key test for the commercial viability of its broader mRNA platform following previous regulatory hurdles.
Regulatory Turnaround and Leadership Changes
The approval represents a reversal from earlier in the year when the agency faced scrutiny over its stance on messenger RNA products. In February, the FDA initially rejected Moderna’s request to review the vaccine application after raising concerns regarding the comparator vaccine used in the clinical trials. That initial refusal drew widespread criticism from medical professionals and scientists.
Following subsequent reviews and a unanimous recommendation by the FDA’s Vaccines and Related Biological Products Advisory Committee in June, agency leadership shifted. Former FDA Commissioner Marty Makary and former biologics head Vinay Prasad stepped down amid controversies surrounding vaccine and drug reviews, and Acting Commissioner Kyle Diamantas subsequently took steps to steady agency operations.
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