Johnson & Johnson's single-dose COVID-19 vaccine meets requirements for emergency use authorisation
Feb 24, 2021
Washington [US], February 24 : The US Food and Drug Administration said on Wednesday that Johnson and Johnson's single-dose COVID-19 vaccine has met the requirements for emergency use authorisation.
CNN, citing the company's analysis, reported that the efficacy of the Johnson and Johnson vaccine against moderate to severe/critical COVID-19 across all geographic areas was 66.9 per cent at least 14 days after the single-dose vaccination, and 66.1 per cent 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," the analysis said.
The drug regulating authority further 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 Authorisation for Vaccines to Prevent COVID-19."
CNN further reported that 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 authorised.
The committee will meet on Friday.
