COVID-19: NAFDAC grants conditional emergency authorisation for J & J vaccine
May 18, 2021
The National Agency for Food, Drug Administration and Control (NAFDAC) says it has granted conditional Emergency Use Authorisation for Johnson and Johnson (J&J) Vaccine to prevent COVID-19.
Information on the approval for J & J, also known as Janssen Vaccine, is in a statement signed by the Director General of the agency, Prof. Mojisola Adeyeye on Tuesday.
Adeyeye said that after thorough evaluation, the NAFDAC Vaccine Committee concluded that the data on the vaccine were robust and met criteria for efficacy, safety and quality.
She added 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.
She noted that “Janssen COVID-19 vaccine is the third vaccine recommended in Nigeria; 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 is effective for 18 years of age and above.
“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).”
Adeyeye said 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 director general further said that the most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.
She explained that the vaccine safety was in line with NAFDAC’s Pharmacovigilance and Safety Monitoring Plan for COVID-19 vaccines.
The NAFDAC boss said that the Janssen COVID-19 vaccine would be closely monitored and subjected to several activities that applied specifically to COVID-19 vaccines.
She said the manufacturers had been required to provide monthly safety reports in addition to the regular updates generated by NAFDAC activities.
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 Ministry of Health and the National Primary Health Care Development Agency (NPHCDA) will announce when the vaccine becomes available for use in Nigeria,” Adeyeye said. (NAN)