COVID-19: NAFDAC approves emergency use of Janssen vaccine

Doosuur Iwambe,Abuja

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of Janssen (Johnson and Johnson) COVID-19 for Nigerians from 18 years and above.

In a statement made available to journalists on Tuesday, the Director-General of the agency, Prof. Mojisola Adeyeye, noted that the approval followed a vivid evaluation by NAFDAC vaccine committee.

According to her, the committee concluded after the evaluation that the vaccine were robust and met criteria for efficacy, safety and quality.

She said, “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.

“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 2 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”.

Speaking on the safety of the vaccine, the NAFDAC boss boss said that vaccine will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.

“In line with the NAFDAC’s Pharmacovigilance and safety monitoring plan for COVID-19 vaccines, Janssen COVID-19 vaccine will be closely monitored and subject 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. Janssen COVID-19 Vaccine works by preparing the body to defend itself against COVID-19.

“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 Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.”