European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID-19 mRNA vaccine. The EMA’s positive CHMP opinion covers people aged 50 and older and will move to a final European Commission decision. Moderna CEO Stéphane Bancel publicly framed the vote as a milestone for respiratory-virus vaccination. The recommendation follows additional clinical data Moderna supplied after a turbulent U.S. review process that prompted the company to pause certain late-stage trials and refile. The EMA’s assessment—based on antibody responses against both influenza and SARS-CoV-2—creates a potential first-mover advantage for Moderna in markets outside the U.S. while regulatory uncertainty persists stateside.