NAFDAC Grants Conditional Emergency Use Authorisation For Jansen COVID-19 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 the media, 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 a 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”.

On side effects, she said the most commonly reported side effects with the vaccine 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 vaccine safety, she said in line with the NAFDAC’s Pharmacovigilance and safety monitoring plan for COVID-19 vaccines, Janssen COVID-19 Vaccine would 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.”

She further explained that unopened vaccine vials can be stored and/or transported frozen at -25°C to – 15°C for up to 24 months and three months when stored at 2 to 8°C.

She also stated that the Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.