The National Agency for Food and Drug Administration and Control (NAFDAC), yesterday, granted conditional Emergency Use Authorisation (EUA) for Janssen (Johnson & Johnson) COVID-19 vaccine to check spread in people from 18 years.
The Director-General, Prof. Mojisola Christianah Adeyeye, in a media statement, said after a thorough evaluation, the NAFDAC Vaccine Committee concluded that data on the jab were robust and met criteria for efficacy, safety and quality.
Adeyeye said the information also showed that the vaccine’s known and potential benefits outweigh known and potential risks, thereby supporting the manufacturer’s recommended use.
Janssen COVID-19 Vaccine is the third therapy recommended in Nigeria for preventing the virus.
According to NAFDAC, the 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 jab was effective at preventing the pandemic in people from 18 years.
The Phase III clinical trial involved over 44,000 people. Half received a single dose of the vaccine and 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 per cent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received the therapy. 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 one to two days,” the document noted.