Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) provisionally approved the R21 malaria vaccine on Monday, April 17th. The vaccine was developed by the University of Oxford and manufactured by the Serum Institute of India. This pre-approval by NAFDAC comes soon after Ghana also approved the vaccine, becoming the first country to do so.
The vaccine was specifically developed to be administered to prevent malaria in children who are between 5 and 36 months old. According to the Nigeria Demographic and Health Survey of 2018, 23% of the malaria cases in the country were children under the age of five. The World Health Organization’s statistics from 2021 showed that in Africa, over 80% of deaths were caused by malaria. The vaccine has been shown to have a 70-80% efficiency rate 12 months after the fourth dose is administered.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline,” NAFDAC’s Director General Professor Mojisola Christianah Adeyeye said at a press briefing on Monday, April 17th in Abuja.
The R21 malaria vaccine has been pre-approved in Nigeria but the final stage of trial data has yet to be published. It also has not been fully approved as safe and effective by WHO, which is still carrying out assessments. General Director Adeyeye indicated that a clinical trial also had to be conducted in Nigeria.
“While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria,” she said.
According to Reuters, Oxford and the Serum Institute have an agreement that will see the Indian company produces approximately 200 million doses of the R21 malaria vaccine. Nigeria expects to receive around 100,000 doses.
Nigeria experiences the highest prevalence of the malaria virus in the world, with 97% of the population prone to contract the disease. The WHO’s 2021 malaria reports show that Nigeria accounts for 27% of the world’s cases of the disease. The West African country also accounts for 32% of the world’s deaths from malaria.