European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for people aged 50 and older. The CHMP concluded the shot produces adequate antibody responses against both viruses and has endorsed it for final EU clearance by the European Commission. Moderna CEO Stéphane Bancel framed the recommendation as a milestone for dual respiratory protection after a difficult regulatory path in the U.S., where additional flu component data delayed the company’s submissions. The EMA opinion positions Moderna to commercialize the first flu–COVID combination in Europe if the Commission ratifies the recommendation. The decision will shift the company’s regulatory strategy: Moderna said it will continue U.S. engagements but signaled increased focus on markets where regulators have been more receptive. The outcome will be watched by vaccine makers and payers weighing combination immunization strategies for older adults.