The European Medicines Agency’s human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza–COVID-19 mRNA vaccine, bringing the product one step from EU authorization. The CHMP concluded the shot produced adequate antibody responses against both viruses and recommended approval for people aged 50 and over. Moderna CEO Stéphane Bancel publicly framed the recommendation as a major milestone in respiratory virus vaccination. Moderna previously faced regulatory setbacks in the U.S., where the Food and Drug Administration requested extra data on the flu component and initially delayed review. The EMA’s endorsement follows Moderna’s submission of new standalone flu data and could allow the company to commercialize the combination vaccine in Europe while U.S. regulatory questions remain unresolved. Regulatory clarity in Europe may accelerate market entry and uptake for a single-injection respiratory strategy, offering Moderna a revenue and credibility lift as it adapts its late-stage development and regulatory plans across jurisdictions.