European health agency recommends approving Moderna's combined flu, COVID vaccine

The European Medicines Agency (EMA) announced Friday it has recommended Moderna’s combined mRNA COVID-19 and flu vaccine be granted market authorization in the European Union, marking the first time the combined respiratory viral vaccine will be approved.

“EMA has recommended granting a marketing authorisation in the European Union (EU) for mCombriax, a messenger RNA vaccine for protecting people aged 50 years and older against COVID-19 and seasonal influenza (flu),” the EMA said in a statement.

Moderna began developing its combined COVID and flu vaccine, called mCombriax, in 2021, reporting positive results from Phase 3 trials in 2024. Full authorization will also make this the first mRNA flu shot approved globally.

“The CHMP’s [EMA’s Committee for Medicinal Products for Human Use] positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine. If approved, this would be Moderna’s fourth marketed product in Europe,” Moderna CEO Stéphane Bancel said in a press release.

“Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA’s rigorous scientific review.”

In the U.S., progress toward approval stalled last year when Moderna announced it had voluntarily pulled its submission for the combined COVID and flu vaccine. The company recently faced a hurdle regarding its mRNA flu vaccine candidate when the Food and Drug Administration refused to review its application, before the agency reversed the decision a week later.

The EMA’s recommendation does not mean the vaccine will hit the European market just yet. As the agency noted, the recommendation must now go to the European Commission for the adoption of a decision on an EU‑wide marketing authorization.