The European Medicines Agency’s CHMP recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID-19 mRNA vaccine for older adults. The committee concluded the vaccine induced adequate antibody responses against both viruses, setting the stage for European Commission authorization. Moderna framed the recommendation as the world’s first regulatory nod for a flu–COVID combo vaccine. CHMP also issued positive opinions for several other medicines in the same review cycle, including a Novartis pill for chronic hives. The EMA decisions diverge from more fraught conversations in the U.S., where Moderna has faced additional agency questions and a paused filing pathway. A European clearance would let Moderna launch the combination where regulatory headwinds have been comparatively smoother. The CHMP recommendation could accelerate uptake into seasonal vaccine programs for at-risk groups, and it reorients Moderna’s vaccine strategy as the company balances pandemic-era growth with pipeline diversification.
Get the Daily Brief