European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined influenza and COVID-19 mRNA vaccine, clearing a major regulatory hurdle for the product in people aged 50 and older. The EMA’s CHMP found the vaccine produced adequate antibody responses against both viruses, according to the company and regulator statements. Moderna CEO Stéphane Bancel highlighted the milestone as the world’s first flu–COVID combination vaccine and said the decision will move to the European Commission for final authorization. The recommendation follows a fraught regulatory path in the U.S., where Moderna faced additional data requests and delayed review timelines from the FDA. The CHMP’s positive opinion could accelerate market access in Europe even as questions linger about U.S. prospects. For vaccine manufacturers and payers, an approved combination shot would change seasonal immunization logistics and product positioning. The recommendation was reported by the EMA and covered in major outlets including Reuters and company releases.