Johnson & Johnson’s coronavirus vaccine is safe and effective against the novel coronavirus, the Food and Drug Administration said in a briefing document Wednesday, putting the drugmaker’s candidate on track for possible emergency-use authorization in the coming days.
The FDA determined that the single-dose vaccine is 66% effective at preventing moderate to severe COVID-19 cases and 85% effective against the most severe illness.
The vaccine also may prevent asymptomatic COVID-19 infection starting at about four weeks, according to the FDA document, CNN reported.
An independent FDA advisory committee will meet Friday to discuss whether the Johnson & Johnson data is strong enough to recommend final approval.
If Johnson & Johnson receives final approval from the FDA, only a few million doses expected to be ready for shipping in the first week. The company told Congress recently that it expects to manufacture 20 million doses by the end of March and 100 million by summer, The Associated Press reported.
Two separate vaccines developed by Pfizer/BioNTech and Moderna have already gotten emergency authorization from the FDA, though those vaccines both require two doses.
Johnson & Johnson tested its product on 44,000 people in the U.S., Latin America and South America. The company previously announced the vaccine worked better in the U.S. at a level of 72% effectiveness against moderate to severe COVID-19 cases, compared to 66% in Latin America and 57% in South Africa, two locales where new, more contagious strains of the virus have been discovered.
Nevertheless, in each country where its citizens were inoculated with the Johnson & Johnson vaccine, it was shown to be highly effective against the most serious symptoms, with early results showing no hospitalizations or deaths starting 28 days after vaccination.
As of Wednesday, the U.S. has administered about 65 million of its 82.1 million available coronavirus vaccine doses, according to the Centers for Disease Control and Prevention.