NAFDAC approves ‘Johnson and Johnson’ COVID-19 vaccine

The National Agency for Food and Drug Administration and Control (NAFDAC) has granted emergency use authorisation for the ‘Johnson and Johnson’ vaccine in the country.

The Director General of the agency, Prof Moji Adeyeye, made the disclosure in a statement issued by the agency on Tuesday.

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She said, “NAFDAC is hereby granting conditional Emergency Use Authorization for Janssen COVID-19 Vaccine to prevent COVID-19 in people from eighteen (18) years of age.

“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.

“The data also show that the vaccines known and potential benefits outweigh its known and potential risks thereby supporting the manufacturers recommended use.”

Janssen COVID-19 Vaccine is the third vaccine recommended in Nigeria for preventing COVID-19. The vaccine is administered as a single dose.

The NAFDAC boss said 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.

She said the phase III clinical trial involved over 44,000 people and that half received a single dose of the vaccine and half were given placebo (a dummy injection).

“The trial found a 67% 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 of the vaccine are 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.

The agency promised to closely monitor the vaccine, and subject it to several activities that apply specifically to COVID-19 vaccines.

The Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria, the agency said.