The National Agency for Food and Drug Administration and Control (NAFDAC) has authorized the use of Janssen COVID-19 vaccine in Nigeria.
The agency approved the conditional emergency use of the vaccine on Tuesday.
The Director-General of NAFDAC, Mojiola Adeyeye, said in a statement that the approval followed evaluation for efficacy, adding that the vaccine met quality assurance standard.
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Adeyeye said the Janssen COVID-19 vaccine is administered as a single dose and is similar to the Pfizer vaccine earlier approved by the agency on April 30.
The DG said 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.
The statement reads in part, “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.
“The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days”.