Nigeria is now the second country to approve the R21 malaria vaccine manufactured by the Serum Institute of India and developed at the University of Oxford.

The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, disclosed this on Monday at a press briefing in Abuja.

Prof Adeyeye disclosed that the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.

She added that 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.

She 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 further said that the dossier of the vaccine was subjected to independent review at two levels, adding 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.

“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries, and made recommendations accordingly.

“Overall, the assessment was scored as adequate -fully compliant with standards, and the report was submitted to the Director General.

“The review of NAFDAC’s Committee has always been guided by the same international standards and best practices with the same modality of an independent review by members followed by long hours of plenary where a rigorous assessment of each review took place. The Committee also independently scored the assessment as satisfactory and forwarded it to the Director General”, she added.