Moderna files for U.S. vaccine authorization, will seek EU nod

Moderna Inc said it has applied for U.S. emergency authorization for its COVID-19 vaccine after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns.

The U.S. Food and Drug Administration said an advisory committee would meet to discuss the request on Dec. 17, making Moderna’s candidate the second highly effective vaccine likely to receive U.S. regulatory backing and a potential roll out this year.

A shot developed by Pfizer Inc and BioNTech SE that was 95% effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the emergency use authorizations (EUA)after the advisers make their recommendations.