Moderna says FDA reversing course, will review mRNA flu shot | 18 Feb 2026 | Moderna said Wednesday that the Food and Drug Administration is reversing course, and will now review the company’s mRNA flu shot. The reversal comes after Moderna said last week that the FDA’s Center for Biologics Evaluation and Research told the company that it would not initiate a review of the investigational mRNA vaccine. Moderna then requested a Type A meeting with the FDA, which is a high-priority discussion, to “understand” a path forward. CBER Director Vinayak Prasad said in a letter that the refusal was because Moderna chose a standard-dose seasonal flu vaccine that has already been licensed as a comparison, according to the company. He cited the lack of an “adequate and well-controlled” study with a comparison that “does not reflect the best-available standard of care.”