Amid US ordeal, Moderna wins EU approval for flu/COVID-19 combo shot

In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.

Moderna has secured the European Commission’s go-ahead for its combination flu and COVID-19 vaccine, handing the mRNA specialist a much-needed regulatory win after a rough few months of dealing with the U.S. FDA.

The shot, which will carry the brand name mCOMBRIAX, combines the next-generation COVID-19 vaccine mNEXSPIKE and the investigational flu vaccine mRNA-1010. The European approval covers its use across all 27 European Union member states—plus Iceland, Liechtenstein and Norway—for the active immunization of people 50 years and up, according to a Tuesday company release.

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