WASHINGTON — A U.S. Food and Drug Administration advisory panel is scheduled to meet today to discuss the request for emergency-use authorization of Johnson & Johnson’s one-dose coronavirus vaccine.
According to the agency’s website, the Vaccines and Related Biological Products Advisory Committee will review data and decide whether to recommend approving the vaccine during the meeting, slated from 9 a.m. to 5:30 p.m. A livestream will be available online.
After the committee makes its decision, the FDA likely will decide in the coming days whether to grant approval for emergency use in the United States, The Associated Press previously reported.
The 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.” Read the documents here.
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. The company previously announced that the vaccine had a higher efficacy of 72% among U.S. participants, compared with 66% in Latin America and 57% in South Africa.
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.
— The Associated Press contributed to this report.
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