Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Core Viewpoint - The U.S. FDA has issued a Refusal-to-File letter for Moderna's investigational influenza vaccine mRNA-1010, indicating that it will not initiate a review of the biologics license application despite prior consultations suggesting otherwise [1] Group 1: FDA Decision - The FDA's Center for Biologics Evaluation and Research (CBER) notified the company of its decision not to review the BLA for mRNA-1010 [1] - Moderna had utilized a Priority Review Voucher to expedite the review process for the application [1] Group 2: International Submissions - mRNA-1010 has been submitted and accepted for review in the European Union, Canada, and Australia [1] Group 3: Financial Guidance - The company does not anticipate any impact on its financial guidance for 2026 as a result of the FDA's decision [1]