The National Agency for Food and Drug Administration and Control (NAFDAC) has granted conditional Emergency Use Authorisation for the Janssen COVID-19 vaccine in Nigeria, making it the third vaccine recommended for inoculation in the country.
The Director-General of NAFDAC, Mojiola Adeyeye, disclosed this in a statement released on Tuesday.
According to her, after a thorough evaluation, the NAFDAC Vaccine Committee concluded that the vaccine met quality assurance standards.
“The Janssen COVID-19 vaccine is administered as a single dose. 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.
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“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,” she said.
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Adeyeye said that the Federal Ministry of Health and the National Primary Healthcare Development Agency (NPHDA) would announce further details on when the vaccine would be available in Nigeria.
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