FDA Rejects Moderna’s Influenza Shot Filing Over Comparator Choice, No Safety Concerns
FDA’s Center for Biologics Evaluation and Research refused to file Moderna’s BLA for mRNA-1010 due to its use of a standard-dose influenza vaccine rather than a best-available comparator, despite no identified safety or efficacy issues. Moderna has requested a Type A meeting with CBER and maintains its 2026 financial guidance.
1. FDA Refusal Details
The FDA’s Center for Biologics Evaluation and Research issued a refusal-to-file letter for Moderna’s mRNA-1010 biologics license application, citing the use of a standard-dose seasonal influenza vaccine comparator instead of one reflecting best-available care. The letter did not raise any safety or efficacy concerns, but deemed the study design inadequate for review under existing regulations.
2. Moderna’s Response and Next Steps
Moderna’s leadership has requested a Type A meeting with CBER to clarify the basis for the refusal and resolve comparator issues. The company stated it does not expect this regulatory setback to alter its revenue projections or 2026 financial guidance.
3. International Regulatory Pathway
Outside the U.S., mRNA-1010 applications have been accepted for review in the EU, Canada, and Australia, with potential approvals anticipated between late 2026 and early 2027. Moderna plans further submissions in additional markets throughout 2026 to secure broader regulatory clearance.