By Onyebuchi Ezigbo
The National Agency for Food and Drug Administration and Control (NAFDAC) has granted approval for a conditional emergency use authorisation for Johnson & Johnson COVID-19 vaccine to prevent COVID-19.
It is to be administered to people from 18 years of age.
In a statement issued Tuesday in Abuja, the Director General of the agency, Prof. Mojisola Adeyeye, said: “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 outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
Janssen COVID-19 vaccine, also known as Johnson & Johnson vaccine, is the third vaccine recommended in Nigeria for preventing COVID-19.
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 is 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% reduction in the number of symptomatic COVID-19 cases after 2 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.
Adeyeye said that in line with the NAFDAC’s pharmacovigilance and safety monitoring plan for COVID-19 vaccines, Janssen COVID-19 vaccine will be closely monitored and subjected to several activities that apply specifically to COVID-19 vaccines.
According to her, the manufacturers are required to provide monthly safety reports in addition to the regular updates generated by NAFDAC activities.
Janssen COVID-19 vaccine works by preparing the body to defend itself against COVID-19.
She added that 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.
Adeyeye said that the Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.
