Moderna Inc’s COVID-19 vaccine is safe and 94% effective at preventing the virus, according to the US Food and Drug Administration, clearing the way for regulatory authorization this week.
The FDA intends to authorize emergency use of the vaccine on Friday, according to the New York Times, which cited unnamed sources.
The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as Monday. The Pfizer-BioNTech vaccine, cleared last week, was the first to be authorized.
The high efficacy of the Moderna vaccine was noted after two doses given 28 days apart. This is about the same level of effectiveness as the Pfizer vaccine.
The 54-page document said there were “no specific safety concerns” and that serious adverse reactions were rare.
But there is also evidence suggesting that just one dose of Moderna’s may stop the virus’s spread. A second document published on the FDA website Tuesday shows asymptomatic infection was reduced by 63 percent after the first shot.
The FDA found a 94.1% efficacy rate out of a trial of 30,000 people, according to the document they released.
The news comes as the US coronavirus death toll passed a grim milestone of 300,000.
Endorsement of the Moderna vaccine by FDA scientists was announced on Tuesday, two days before the vaccine panel meets to discuss emergency approval.
Last week, the FDA released similar data from Pfizer before voting to issue approval.
If approved by the team of experts later this week, and by the FDA’s vaccine chief, shipments could begin within 24 hours.
Moderna’s is the second vaccine the FDA has considered, behind one from Pfizer Inc. and Germany’s BioNTech, which was authorized last week. Hospitals in the US began giving the Pfizer shots on Monday.