After initially refusing to review a candidate mRNA vaccine developed by Moderna Inc for influenza, the US Food and Drug Administration has reversed itself and agreed to consider the product for a marketing authorisation. The decision was announced by Moderna on 18 February and follows a meeting between the agency and the company during which a compromise was reached.
Moderna had initially submitted data from a Phase 3 trial showing that the vaccine was safe and effective when compared with a standard dose of an approved vaccine. However the director of the FDA’s biologics evaluation and research division at the agency, Vinayak Prasad, issued a refusal-to-file letter to the company saying that the control arm of the trial did not reflect the best-available standard of care and therefore the application could not be progressed.
According to Moderna, the latest meeting with the FDA resulted in a compromise under which the company will seek approval for its vaccine via a regulatory pathway based on age. It will seek full approval for adults from 50 to 64 years of age and an accelerated approval for adults 65 years and older, along with a post-marketing requirement to conduct an additional study in older adults. The FDA has assigned 5 August as the expected date for a decision. Pending the review and formal approval the vaccine, mRNA-1010, would be available for US adults 50 years of age and older, including adults 65 years and older, for the 2026/2027 flu season, the company said.
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