The National Agency for Food and Drug Administration and Control (NAFDAC), has approved Janssen, also known as Johnson and Johnson COVID-19 vaccine, for emergency use in the county. Director-General of NAFDAC, Prof. Mojisola Adeyeye, who made this known in a statement made available to newsmen on Tuesday in Abuja, said the vaccine having gone through a comprehensive evaluation by the Agency’s vaccine committee, has been certified safe for use. Adeyeye while reiterating the vaccine was administered as a single dose, noted that results from a clinical trial involving people in the United States, South Africa and Latin American countries, reveled the Janssen COVID- 19 Vaccine was effective at preventing COVID-19 in people from 18 years of age. She said: “The data also show 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 is the third vaccine recommended in Nigeria for preventing COVID-19.
“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 percent 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.”
Adeyeye further gave assurances of close safe monitoring of the vaccines in line with NAFDAC’s Pharmacovigilance and safety monitoring plan for COVID-19 vaccines. “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. “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. “The Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.”