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European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19
mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents
About this update from Moderna, Inc.
[{"type":"text","content":"mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinionmCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.\"The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review.\"mCOMBRIAX builds on the advances of mNEXSPIKE®, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia.The CHMP opinion is supported by results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD® (licensed in the European Union as Efluelda®), a high-dose influenza vaccine, and Spikevax®, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix®, a standard-dose influenza vaccine, and Spikevax.All primary endpoints demonstrating the non-inferiority of immune respons...