The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the R21 malaria vaccine manufactured by the Serum Institute of India. The Director General of NAFDAC, Prof. Mojisola Adeyeye, announced the approval at a press briefing in Abuja on Monday, making Nigeria the second country, after Ghana, to endorse the new malaria vaccine developed at the University of Oxford.
Prof. Adeyeye explained that the vaccine is indicated for the prevention of clinical malaria in children aged 5 to 36 months. Nigeria expects to receive at least 100,000 donated doses soon, after which market authorisation will commence and arrangements will be made with the National Primary Health Care Development Agency. She added that NAFDAC, exercising its mandate under the NAFDAC Act CapN1, LFN 2004, is granting registration approval for the R21 malaria vaccine (recombinant, adjuvanted) produced 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. Each 0.5 ml dose contains 5 µg of R21 malaria antigen and 50 µg of Matrix‑M1 adjuvant, packaged in a ready‑to‑use vial for intramuscular injection. The vaccine must be stored at 2‑8 °C.
The vaccine dossier underwent an independent two‑level review. First, NAFDAC’s Vaccine Advisory Committee evaluated it using World Health Organization standards, International Council for Harmonisation (ICH) guidelines, European Medicines Agency requirements, and rigorous scientific criteria specific to malaria and the Nigerian context. Committee members reviewed all sections independently, then met in plenary to discuss findings, raise queries, and make recommendations. The assessment was scored as fully compliant with standards, and the report was submitted to the Director General.
The Joint Review Committee concluded that the dossier substantially complied with the best international standards. It found the data on efficacy, safety, and quality to be robust, determining that the vaccine’s known and potential benefits outweigh its risks. The committee highlighted the importance of an effective malaria vaccine—offering 75 % protection—as a critical tool for Nigeria, which bears the highest malaria burden. It recommended a provisional approval in line with the WHO’s Malaria Vaccine Implementation Guideline, along with additional phase‑four clinical trials and pharmacovigilance studies in Nigeria to address the heterogeneous nature of malaria transmission. The committee also expressed interest in data on the 25 % of cases not covered by the vaccine to inform further research.
Four African countries account 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 % of the population is at risk of malaria.
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