Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine.
The letter, signed by Vinayak Prasad, MD, chief medical and scientific officer, cited the lack of an “adequate and well-controlled” comparator arm as the sole reason for the decision, stating that Moderna’s use of a licensed standard-dose vaccine did not reflect the “best-available standard of care,” according to a Feb. 10 news release from the company. The letter raised no safety or efficacy concerns.
Moderna said the decision contradicts written guidance it received from the FDA in April and August 2024, when the agency reviewed and provided feedback on Moderna’s phase 3 protocol and pre-submission materials. The company submitted two phase 3 studies supporting its application, including one with 43,808 participants.
Moderna has requested a Type A meeting with the FDA to discuss the decision. The vaccine has already been accepted for review in the EU, Canada and Australia. The company said it does not expect the FDA’s decision to affect its 2026 financial guidance.
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