FDA Report Says Johnson & Johnson Coronavirus Vaccine Is Safe And Effective

By Jason Hall

February 24, 2021

The United States Food and Drug Administration has approved the Johnson & Johnson COVID-19 vaccine for emergency use authorization, a major step in bringing a third vaccine to the U.S marketplace.

A staff report released Wednesday (February 24) intended to brief the FDA's Vaccines and Related Biological Products Advisory Committee reports the single-dose Johnson & Johnson vaccine had a 66.9% efficiency against moderate to severe/critical COVID-19 at least 14 days after vaccination and a 66/1% efficiency 28 days after vaccination, CNN reports.

"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," the analysis said via CNN.

The FDA said it reviewed the data for the the Johnson & Johnson vaccine, which showed it was "consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to prevent COVID-19," according to a briefing document shared by the administration.

The Vaccines and related Biological Products Advisory Committee, which is an independent group of FDA advisers, is scheduled to meet on Friday (February 26) to look over the documents and decide whether the Johnson & Johnson vaccine should be recommended for authorization.

The Pfizer and Moderna vaccines have already been authorized for use in the United States.

Photo: Getty Images

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