Moderna to ask the FDA to greenlight its coronavirus vaccine

Moderna to ask the FDA to greenlight its coronavirus vaccine

Biotechnology company Moderna, one of the leaders in the race for a coronavirus vaccine, announced it would file Monday for regulatory clearance — a critical milestone that brings the United States a step closer to having two coronavirus vaccines before the end of the year.

Moderna’s vaccine was 94 percent effective at preventing illness in a 30,000-person clinical trial, the company said — a performance that exceeds expectations and is on par with the best pediatric vaccines. All 30 cases of severe covid-19, the illness caused by the virus, were in a group that received a placebo.

The application will arrive as public health experts gird for a blitz of coronavirus cases seeded by holiday travels and gatherings — a surge coming so soon that no vaccine can blunt it. But Moderna’s filing marks the fourth Monday in a row with good news about the vaccine effort and means the United States could have enough vaccine to treat 20 million people by year’s end, between doses of Moderna’s vaccine and those of another candidate that is about a week ahead from Pfizer and German firm BioNTech. The Food and Drug Administration could authorize the vaccines for emergency use by mid- to late December.