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FDA refuses to review Moderna’s mRNA flu vaccine

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#FDA #Moderna #mRNA #FluVaccine #News
Science News
FDA refuses to review Moderna’s mRNA flu vaccine Read Full Article #FDA #Moderna #mRNA #FluVaccine #News
💉 The FDA has refused to review Moderna's application for its mRNA flu vaccine, mRNA-1010, citing issues with the design of its Phase 3 trial, specifically the comparator vaccine used.

🤔 Moderna stated they were surprised by the FDA's decision, as the trial design, which compared mRNA-1010 to licensed vaccines like GlaxoSmithKline's Fluarix, had been reviewed and accepted by the FDA on at least two prior occasions in April 2024 and August 2025.

🔬 The Phase 3 trial for mRNA-1010 enrolled nearly 41,000 participants and found the mRNA vaccine to be superior to the comparator vaccines.

#Moderna #FDA #VaccineNews