The Director General of NAFDAC, Prof Mojisola Adeyeye, announced during a press briefing in Abuja that the R21 malaria vaccine produced by the Serum Institute of India has been approved for use in Nigeria.
The vaccine is specifically intended for the prevention of clinical malaria in children aged between 5 to 36 months. Nigeria is the second country, after Ghana, to approve the University of Oxford-developed vaccine. 100,000 doses of the vaccine are expected to be donated soon, after which market authorisation will begin, and the National Primary Health Care Development Agency will make further arrangements.
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 a sterile solution of an adjuvanted protein vaccine. It is presented in a vial as a ready-to-use liquid formulation for intramuscular injection. The vaccine dosage is 0.5ml and contains 5µg of R21 Malaria antigen and 50µg of Matrix-M1 as an adjuvant.
“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.”
According to her statement, the vaccine’s dossier underwent independent review at two stages. The first stage involved an independent evaluation by NAFDAC’s Vaccine Advisory Committee. This evaluation was based on the World Health Organisation’s standards across relevant domains, as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines and European Medicines Agency guidelines. The second stage of the review process involved a rigorous assessment of the vaccine’s scientific validity, the context of malaria in Nigeria, and the best practices for 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.”
Prof Adeyeye further noted that the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked and it fulfilled the requirements for quality, safety, and efficacy.
“The 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.
“The 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.
“The 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.
“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,” Prof Adeyeye concluded.
