NAFDAC Approves Janssen COVID-19 Vaccine for Nigeria

By Onyebuchi Ezigbo

The National Agency for Food and Drug Administration and Control (NAFDAC) has granted approval for a conditional emergency use authorization for Johnson & Johnson (J&J) COVID-19 also known as Janssen vaccine to prevent COVID-19.

It is to be administered to people from 18 years of age.

In a statement issued yesterday in Abuja, the Director General of the agency, Prof. Mojisola Adeyeye said that: “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”.

She said that the data also showed that the vaccine’s known and potential benefits outweighed 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 vaccine efficacy.

The vaccine is to be administered as a single dose.

According to NAFDAC, 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.

While giving details of the approving processes underwent by the vaccine, NAFDAC said that its phase III clinical trial involved over 44,000 people, half of whom received a single dose of the vaccine and half were given placebo (a dummy injection).

It said that 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 1-2 days.vaccine safety,” it said.