FDA says Johnson & Johnson COVID-19 vaccine meets requirements for emergency use authorization

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.

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, a new analysis meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee said.

“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.”

An independent group of FDA advisers, the Vaccines and related Biological Products Advisory Committee, will consider the documents and make a recommendation about whether the COVID-19 vaccination should be authorized. The committee meets on Friday.