The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the Johnson & Johnson (J&J) COVID-19 vaccine for immediate emergency use in Nigeria.
The announcement was made in a statement issued by Mojisola Adeyeye, director-general of NAFDAC.
The J&J vaccine would be the third vaccine to be approved by the country’s drug control and administration agency. Pfizer and AstraZeneca had previously been certified safe by the agency.
According to Adeyeye, NAFDAC had conducted a thorough evaluation of the J&J vaccine and concluded that the data on the vaccine was robust and met the criteria for efficacy, safety and quality.
She said the benefits of the vaccine outweigh its known risks.
“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,” she said.
“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).”
The NAFDAC DG said the trial found a 67 percent reduction in the number of symptomatic COVID cases after two weeks in people who received J&J COVID-19 vaccine.
She said the vaccine will be monitored and subjected to several procedures that applied specifically to COVID-19 vaccines.
According to her, the manufacturers had been required to provide monthly safety reports in addition to the regular updates generated by NAFDAC activities.
Adeyeye said the ministry of health and the National Primary Health Care Development Agency (NPHCDA) will announce when the vaccine becomes available for use in the country.