Coronavirus: Johnson & Johnson vaccine has ‘favorable safety profile,’ FDA briefing documents say

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.

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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.

Read the documents here.

— The Associated Press contributed to this report.

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