European Commission authorizes mCOMBRIAX, the first flu plus COVID combination vaccine

The European Commission granted marketing authorization for mCOMBRIAX, Moderna's mRNA vaccine combining flu and COVID-19 antigens, for adults 50 and older. Moderna calls it the first flu plus COVID combination vaccine to be authorized anywhere. The approval rests on a Phase 3 study of about 8,000 adults, while the US path is still waiting on FDA guidance.

• Marketing authorization covers adults 50 and older
• Based on a Phase 3 study of about 8,000 adults in two age cohorts
• Described by Moderna as the first flu plus COVID combination vaccine authorized
• US resubmission still awaiting FDA guidance