NAFDAC approves emergency use of Johnson & Johnson COVID-19 vaccine
The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the use of the Johnson & Johnson COVID-19 vaccine in Nigeria to
The vaccine is to be administered to persons from eighteen years of age.
The vaccine is the third vaccine recommended in Nigeria for preventing COVID-19. NAFDAC had already approved the use of the Oxford-AstraZeneca jab.
the director-general of NAFDAC Mojisola Adeyeye said the Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.
She explained that 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 adding that 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.
Adeyeye noted that Janssen COVID-19 Vaccine is administered as a single dose and results from a clinical trial involving people in the United States, South Africa and Latin American countries found it was effective at preventing COVID-19 in people from 18 years of age.
According to her, the Phase III clinical trial involved over 44,000 people and 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”.
She said, “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.
On the safety of the vaccine, 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 subject to several activities that apply specifically to COVID-19 vaccines.
She said, “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”.
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