Nigeria: NAFDAC Grants Conditional Approval for Janssen Covid-19 Vaccine

The National Agency for Food and Drug Administration and Control (NAFDAC), has granted conditional Emergency Use Authorisation for Janssen COVID-19 vaccine in Nigeria.

The Janssen COVID-19 vaccine is the third vaccine recommended for administration in the country.

The director-general of NAFDAC, Prof. Mojiola Adeyeye, in a statement on Tuesday, said unopened vaccine vials can be stored and/or transported frozen at -25°C to - 15°C for up to 24 months and 3 months when stored at 2 to 8°C.

According to her, 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 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.

"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 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 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 1-2 days," she explained.

On the vaccine safety, Adeyeye said NAFDAC, in line with its pharmacovigilance and safety monitoring plan for COVID-19 vaccines, will closely monitor and subject the Janssen COVID-19 Vaccine 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.

The DG informed that the Federal Ministry of Health and the National Primary Healthcare Development Agency (NPHDA) will announce when the vaccine becomes available for use in Nigeria.

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