WASHINGTON — Johnson & Johnson’s coronavirus vaccine has a “favorable safety profile with no specific safety concerns,” the U.S. Food and Drug Administration said in briefing documents released Wednesday.
The news comes two days before members of the FDA’s Vaccines and Related Biological Products Advisory Committee are scheduled to meet to discuss emergency-use authorization of the one-dose COVID-19 vaccine in the United States. The agency is expected to decide whether to grant approval in the following days.
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.
The FDA previously granted emergency-use authorization for coronavirus vaccines made by Pfizer and Moderna, the AP reported. Unlike Johnson & Johnson’s shot, those vaccines require two doses each but are reported to be about 95% effective.
Johnson & Johnson FDA briefing by National Content Desk on Scribd
— The Associated Press contributed to this report.
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