Moderna to File for Approval of Its COVID-19 Vaccine With US and EU Regulators

A subject receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle, Wash., on March 16, 2020. Ted S. Warren/AP Photo

Biotech firm Moderna said it will on Monday file requests with both U.S. and European regulators for approval of its COVID-19 vaccine, which clinical trials show is “generally well tolerated” and no serious safety concerns have been identified.

“Moderna plans today to request EUA (Emergency Use Authorization) from the U.S. FDA (Food and Drug Administration),” the company said in a statement, adding it would also “apply for a conditional marketing authorization with the European Medicines Agency (EMA).”