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The Food and Drug Administration has agreed to review Moderna's application for an mRNA-based influenza vaccine, the company announced on February 18, 2026 — a significant reversal after the agency's earlier refusal triggered sharp criticism from the pharmaceutical industry and public health community. The vaccine, designated mRNA-1010, targets adults aged 50 and older and has already been accepted for review in the European Union, Canada, and Australia.
Under the revised framework, the FDA will evaluate the vaccine for adults aged 50 to 64 through its standard approval pathway and for adults 65 and older via accelerated approval, contingent on Moderna completing a post-marketing study in that older age group. The agency has set a PDUFA review target date of August 5, 2026. If approved, the vaccine could be available for the 2026–2027 flu season.
The reversal comes after a "refuse-to-file" letter, dated February 3 and reported by CIDRAP and NBC News, in which Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), determined that Moderna's Phase 3 trial — which enrolled more than 40,000 adults — was not "adequate and well-controlled." Prasad objected to Moderna's use of Fluarix Quadrivalent, a GSK standard-dose vaccine, as the comparator arm, arguing that it did not represent the best available standard of care for adults over 65, for whom a high-dose formulation is available. Critically, no safety or efficacy concerns were cited.
Moderna disputed the rationale, noting that the FDA had explicitly agreed to the comparator choice in prior written communications, as recently as 2025. Vaccine policy expert Dorit Reiss of UC Law San Francisco told NBC News that the FDA could have demanded a different comparator in 2024 and did not. "Changing course midstream is problematic," she said, "and would lead industry, understandably, not to trust the FDA."
The industry backlash extended well beyond Moderna. Pharmaceutical executives warned that if the FDA were to reverse previously agreed-upon trial designs, the predictability needed for long-term R&D investment would be undermined. Moderna President Stephen Hoge noted that regulatory instability affects not just vaccines but the entire innovation pipeline.
The FDA's agreement to proceed with review represents a pragmatic step forward. However, the episode has exposed fault lines in how regulatory commitments are honored — a concern that managed care organizations, payers, and health systems will be watching as they weigh coverage frameworks for future vaccine innovations.
