NAFDAC grants emergency use authorization for Janssen COVID-19 Vaccine

The National Agency for Food, Drug Administration and Control (NAFDAC) has granted conditional Emergency Use Authorization for Janssen COVID-19 vaccine to prevent COVID-19 in people from 18 years of age.

Professor Mojisola Adeyeye, the director-general of the agency, said in a statement on Tuesday that after a thorough evaluation, NAFDAC Vaccine Committee concluded that the data on the vaccine were robust and met criteria for efficacy, safety and quality.

She said the data also showed 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. It is administered as a single dose.

Adeyeye said that 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 of these 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 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 one to two days,” she said.

Adeyeye said the Janssen COVID-19 Vaccine would be closely monitored and subjected 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,” she said.

According to her, 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 three months when stored at 2 to 8°C.

The NAFDAC boss said the Ministry of Health and the National Primary Health Care Development Agency would announce when the vaccine becomes available for use in Nigeria.