European regulators recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for people aged 50 and older. The European Medicines Agency’s CHMP concluded Moderna’s data showed adequate antibody responses to both viruses after the firm supplied additional influenza component data following earlier U.S. questions. Moderna CEO Stéphane Bancel publicly framed the endorsement as a milestone for respiratory virus vaccination. The CHMP recommendation follows a fraught U.S. review in which the FDA requested more standalone flu data, prompting Moderna to withdraw and resubmit aspects of its dossier. The EMA action clears a path to European Commission authorization and potential market entry while U.S. regulatory prospects remain unsettled. For vaccine developers and platform companies, the decision signals divergent regulator expectations across regions and underscores the operational risks of combo‑vaccine development, particularly when components have separate comparators or trial requirements.