Health News
Nigeria Becomes Second Country To Approve R21 Malaria Vaccine After Ghana
The National Agency for Food and Drug Administration and Control has approved the R21 malaria vaccine manufactured by the Serum Institute of India.
The Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Monday at a press briefing in Abuja.
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 āNAFDAC 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.
āThe Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agencyās Drug and Related Products Registration Regulation 2021.
āThe 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 5Āµg and Matrix-M1 50Āµg as an adjuvant filled in a vial as a ready-to-use liquid formulation for intramuscular injection.
āThe 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 Ā°C.ā
She said the dossier of the vaccine was subjected to independent review at two levels.
She said the dossier was reviewed by NAFDACās 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.
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āNEVAC 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.
āOverall, the assessment was scored as adequate -fully compliant with standards, and the report was submitted to the Director General.
āThe review of NAFDACās 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.ā
According to her, the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.
She said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.
It was also adjudged that the vaccineās known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturerās recommended use.
āThe Joint Review Committee recognised the importance of an effective malaria vaccine (with 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.
āThe Joint Review Committee also recommended additional phase four clinical trial, pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.
āThe Joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25 per cent not covered to understand issues bothering on non-protection that could inform further research.
āA provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHOās Malaria Vaccine Implementation Guideline,ā she noted.
The Eaglesforesight correspondent reports that four African countries accounted for just over half of all malaria deaths worldwide ā 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.