Moderna Inc said on Monday 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, - Reuters reports.
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.
Moderna, which also plans to seek European approval, reported that its vaccine’s efficacy was consistent across age, race, ethnicity and gender demographics as well as having 100% success in preventing severe cases of the disease that has killed nearly 1.5 million people worldwide.
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.
