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Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization — another step toward the authorization of a third shot for the United States.

The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination, according to the analysis, which is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee.
The committee is an independent group that determines if the vaccine works and if it’s safe. After the group meets Friday, it will make its authorization recommendation to the FDA, which typically follows the recommendation.

Any time it approves or authorizes a vaccine, the FDA releases an analysis of the clinical trial data that the company has submitted. What the FDA found in the trial data looked good.

“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.

In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”