Nigeria: Covid-19 – NAFDAC Grants Conditional Emergency Use Authorisation for Jansen Vaccine


The National Agency for Food and Drug Administration and Control, NAFDAC, on Tuesday granted conditional Emergency Use Authorisation for Janssen COVID-19 Vaccine to prevent COVID-19 in Nigerians above 18 years of age.

In a press statement made available to Vanguard, the Director-General of the Agency, Prof Christianah Mojisola Adeyeye said after a thorough evaluation, the NAFDAC Vaccine Committee concluded that the data on the vaccine were robust and met criteria for efficacy, safety and quality.

“The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks thereby supporting the manufacturer’s recommended use. Janssen COVID-19 Vaccine is the third vaccine recommended in Nigeria for preventing COVID-19.”

On vaccine efficacy, Adeyeye noted that the Janssen COVID-19 Vaccine is administered as a single dose and results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Janssen COVID-19 Vaccine was effective at preventing COVID-19 in people from 18 years of age.

She added: “The Phase III clinical trial involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given Janssen COVID-19 Vaccine or placebo.

“The trial found a 67 per cent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received Janssen COVID-19 Vaccine.