Posted by Michael Wonder on 11 Feb 2026
Moderna receives refusal to file letter from the US FDA for its investigational seasonal influenza vaccine, mRNA-1010
10 February 2026 - Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a type A meeting to understand the path forward.
Moderna today announced the US FDA Center for Biologics Evaluation and Research has notified the Company that it will not initiate a review of the biologics license application for its investigational influenza vaccine, mRNA-1010, and has issued a refusal to file letter.
Moderna had exercised a priority review voucher to facilitate a timely review of the application.
