By Promise Eze
In a press briefing in Abuja on Monday, The Director General of The National Agency for Food and Drug Administration and Control (NAFDAC) Prof Mojisola Adeyeye, disclosed that the agency has approved the R21 malaria vaccine.
This makes Nigeria the second country to approve the new malaria vaccine developed at the University of Oxford, after Ghana.
Prof Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
She said the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.
Adeyeye said “NAFDAC in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd.
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“The R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution. A dose which is 0.5ml is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial as a ready-to-use liquid formulation for intramuscular injection.
“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”
She noted that the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee independently using standards of the World Health Organisation across relevant domains, in addition to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria and specifically to Nigeria and best research and manufacturing governance.
Four African countries accounted for just over half of all malaria deaths worldwide – Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), United Republic of Tanzania (4.1%) and Niger (3.9%).
In Nigeria, 97 per cent of the population are at risk of malaria.
