Moderna announces EMA’s CHMP recommends marketing authorization for mCOMBRIAX

Moderna (MRNA) announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX, Moderna’s combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. “The CHMP’s 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,” said Stephane Bancel, Chief Executive Officer of Moderna. “Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA’s rigorous scientific review.”