FDA Deems Johnson & Johnson COVID Vaccine Safe and Effective for Emergency Use
FDA Deems Johnson & Johnson COVID Vaccine Safe and Effective for Emergency Use .
The U.S. Food and Drug Administration (FDA) made the announcement on Feb. 24.
It said Johnson & Johnson's COVID-19 vaccine data is "consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.".
According to an analysis intended to brief the FDA's Vaccines and Related Biological Products Advisory Committee, .
the vaccine was effective against moderate to severe coronavirus 66.9% of the time at least
14 days after the first dose.
Its efficacy rate was 66.1%
at least 28 days after vaccination.
There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, FDA, via analysis.
The Vaccines and related Biological Products Advisory Committee will meet on Feb. 26 to possibly recommend whether the vaccine should be authorized
The U.S. Food and Drug Administration (FDA) made the announcement on Feb. 24.
It said Johnson & Johnson's COVID-19 vaccine data is "consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.".
According to an analysis intended to brief the FDA's Vaccines and Related Biological Products Advisory Committee, .
the vaccine was effective against moderate to severe coronavirus 66.9% of the time at least
14 days after the first dose.
Its efficacy rate was 66.1%
at least 28 days after vaccination.
There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, FDA, via analysis.
The Vaccines and related Biological Products Advisory Committee will meet on Feb. 26 to possibly recommend whether the vaccine should be authorized