The National Agency for Food and Drug Administration and Control (NAFDAC) in efforts to curb the spread of the COVID-19 pandemic has granted conditional approval for emergency purposes to the Janssen COVID-19 vaccine produced by the Johnson&Johnson (J&J) medical device company. In a statement on Tuesday in Abuja, the Director-General, NAFDAC, Dr.Mojisola Adeyeye said the approval for the Janssen vaccine was done “after a thorough evaluation” of the product, adding that the agency’s vaccine committee “concluded that the data on the vaccine were robust and met criteria for efficacy, safety and quality”.
The vaccine is to be administered as a single dose and to people from 18 years of age.
According to the Director-General, the data shows that the vaccine’s known and potential benefits outweigh its known and potential risks.
“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 the 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 a placebo (a dummy injection). People did not know if they had been given Janssen COVID-19 Vaccine or placebo,” she said.
“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.vaccine safety,” the D.G added.