The National Agency for Food and Drug Administration and Control (NAFDAC) disclosed on Tuesday that it has given conditional approval for use of Janssen COVID-19 vaccine in Nigeria.
The agency’s Director-General, Prof. Mojisola Adeyeye stated that the conditional emergency use authorisation of the vaccine, came about after a proper evaluation of the vaccine
She disclosed that the NAFDAC Vaccine Committee concluded that the data on the vaccine were robust and met required standard for use in the country and this decision was made after proper evaluation of the Janssen Vaccine
Adeyeye made known that unopened vaccine vials can be stored and/or transported frozen at -25°C to – 15°C for up to 24 months and 3 months when stored at 2 to 8°C.
The Janssen COVID-19 vaccine is the third vaccine recommended for administration in the country.
The NAFDAC DG said that the data also showed that the vaccine’s known and potential benefits outweighs its known and potential risks thereby supporting the manufacturer’s recommended use.
She also made known that the Federal Ministry of Health and the National Primary Healthcare Development Agency (NPHCDA) will announce when the vaccine becomes available for use in Nigeria.
“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.
“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 percent 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.
The NAFDAC DG further noted that the agency will closely monitor and subject the Janssen COVID-19 Vaccine to several activities that apply specifically to COVID-19 vaccines.
“Manufacturers are required to provide monthly safety reports in addition to the regular updates generated by NAFDAC activities,” she added.