European regulators’ human medicines committee (CHMP) recommended Moderna’s mCombriax (mRNA‑1083) for approval in people aged 50 and older. The CHMP opinion moves the vaccine to the European Commission for final authorization and represents a major regulatory win after the program encountered hurdles with the U.S. FDA. Moderna said the data demonstrated adequate antibody responses against both influenza and SARS‑CoV‑2 and framed the recommendation as the world’s first flu‑plus‑COVID combination vaccine reaching that stage. The recommendation follows Moderna’s accumulation of additional standalone flu data after the FDA requested more evidence in the U.S. filing pathway. EMA’s positive opinion is likely to accelerate market access in Europe even as the company navigates renewed scrutiny and additional data requirements in the U.S. The move also underscores regulators’ differing evidentiary expectations for combination respiratory vaccines.