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FDA Says Johnson & Johnson Covid-19 Vaccine Meets Emergency Use Clearance Requirements

The efficacy of the Johnson & Johnson vaccine against moderate to severe / critical Covid-19 in all geographies was 66.9% at least 14 days after single-dose vaccination and 66.1% at least 28 days after vaccination. vaccination, a new analysis intended to inform the FDA’s Advisory Committee on Vaccines and Related Biologics said.

“There were no specific safety concerns identified in analyzes of subgroups by age, race, ethnicity, medical co-morbidities or previous SARS-CoV-2 infection,” the analysis states.

In a backgrounder, the FDA said it had reviewed the vaccine data and determined that it was “in line with the recommendations set out in the FDA’s guidelines on authorizing emergency use of vaccines. to prevent COVID-19 ”.

An independent group of FDA advisers, the Advisory Committee on Vaccines and Related Biologics, will review the documents and make a recommendation on whether or not to approve the Covid-19 vaccination. The committee meets on Friday.


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