WASHINGTON — A U.S. Food and Drug Administration advisory panel on Friday endorsed a request for emergency-use authorization of Johnson & Johnson’s one-dose coronavirus vaccine.
The endorsement for the EUA, by a 22-0 vote, came after the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee.
A U.S. Centers for Disease Control and Prevention immunization advisory committee must vote to recommend the vaccine and the CDC must accept that recommendation. The CDC’s Advisory Committee on Immunization Practices will look at all the same data and will discuss whether people should get the vaccine, CNN reported.
The question the FDA panel voted on was, “Based on the totality of scientific evidence available, do the benefits of the Janssen COVID-19 vaccine outweigh its risks in individuals 18 years of age and older?”
The vaccine becomes the United States’ third against COVID-19, but the only one that provides enough protection with a single dose, The Washington Post reported. Experts said it could expedite efforts to inoculate the population as virus variants spread, the newspaper reported.
“There are limited options to control the virus,” said Gregory Poland, director of the Vaccine Research Group at the Mayo Clinic, who made a presentation to the FDA advisers as part of the Johnson & Johnson presentation.. “We need vaccines that are effective and well-tolerated, and — importantly — ones that are simple to deploy.”
Coronavirus vaccines made by Pfizer and Moderna have already been approved for emergency use in the U.S. Unlike Johnson & Johnson’s shot, those vaccines require two doses each but are reported to be about 95% effective, the AP reported.
Friday’s meeting comes two days after the committee said in briefing documents that Johnson & Johnson’s coronavirus vaccine has a “favorable safety profile with no specific safety concerns.”
An analysis of data from a Phase 3 clinical trial -- which included 44,000 participants in the U.S., Latin America and South Africa -- found that Johnson & Johnson’s vaccine is about 66% effective overall at preventing moderate to severe cases of COVID-19, according to The Associated Press. Johnson & Johnson previously announced that its vaccine had a higher efficacy of 72% among U.S. participants, compared with 66% in Latin America and 57% in South Africa.
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