BREAKING: NAFDAC approves new COVID-19 vaccine for emergency use

The National Agency for Food and Drug Administration and Control (NAFDAC), has approved Janssen COVID-19 Vaccine for emergency use in Nigeria.

The latest development was made known by the NAFDAC Director-General, Prof. Mojiola Adeyeye, via a statement on Tuesday.

Janssen COVID-19 Vaccine is the third vaccine approved for use in Nigeria after the approval of Oxford-AstraZeneca and Pfizer COVID-19 Vaccines.

The NAFDAC DG stated that information on Janssen COVID-19 Vaccine shows it met the criteria for efficacy, safety, and quality.

“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,” Adeyeye said.

She added that the trial showed a 67 percent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received Janssen COVID-19 Vaccine., noting that the most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea.

The NAFDAC boss further stated that most of the side effects were mild to moderate in severity and lasted 1-2 days.

While speaking on the vaccine safety, Adeyeye noted that NAFDAC, in line with its pharmacovigilance and safety monitoring plan for COVID-19 vaccines, will closely monitor and subject the Janssen COVID-19 Vaccine to several activities that apply specifically to COVID-19 vaccines.