Moderna mRNA vaccine European Commission flu and COVID-19 vaccine mCOMBRIAX EMA approval

Europe has become the first region in the world to authorize Moderna’s mRNA-based combination vaccine against both influenza and COVID-19. The vaccine, designated mRNA-1083 or mCOMBRIAX, received regulatory clearance this week from the European Commission.

This milestone marks the world’s first authorization of a single-dose vaccine targeting both respiratory viruses. The decision follows a positive assessment in February by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended the vaccine for approval.

Moderna’s CEO, Stéphane Bancel, issued a statement welcoming the authorization.

"By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk," Bancel said. "mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."

Despite being developed in the United States, the vaccine has yet to receive clearance from the U.S. Food and Drug Administration (FDA). Regulatory discussions in the US are ongoing, leaving the vaccine unavailable to American patients for now.

Source: Ars Technica
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