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Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010
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
About this update from Moderna, Inc.
[{"type":"text","content":"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 forwardmRNA-1010 has been submitted and accepted for review in the EU, Canada and AustraliaCompany does not expect any impact on its 2026 financial guidance CAMBRIDGE, MA / ACCESS Newswire / February 10, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has notified the Company that it will not initiate a review of the biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File (RTF) letter. Moderna had exercised a Priority Review Voucher to facilitate a timely review of the application.CBER's RTF letter, signed by Center Director Vinayak Prasad, MD, MPH, identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna's application. Specifically, the letter cited the lack of an \"adequate and well-controlled\" study with a comparator arm that \"does not reflect the best-available standard of care.\" Neither the relevant regulation, 21 C.F.R. § 314.126 (Adequate and well-controlled studies), nor the FDA's guidance for industry on seasonal influenza vaccines contain any reference to the use of a comparator reflecting the \"best-available standard of care.\" The letter did not identify any specific safety or efficacy concerns regarding mRNA-1010.The letter is inconsistent with previous written communications from CBER to Moderna. In April 2024, Moderna submitted the Phase 3 study protocol to CBER for review during a pre-Phase 3 consultation. CBER provided written guidance noting that \"while we agree it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study, we recommend you use a vaccine preferentially recommended for use in older adults by the ACIP (i.e., Fluzone HD, Fluad or Flublok) for participants >65 years of age in the study. Data on comparative efficacy of your vaccine against an influenza vaccine preferentially recommended for use in the >65 years age group may help inform ACIP's recommendation for the use of your vaccine in the older adult popula...