The federal government has granted provisional approval for the Malaria Vaccine, R21/Matrix developed by scientists at Oxford University for use in Nigeria.
Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye, at a press briefing on Monday said the vaccine would be used for the prevention of malaria in children from 5 months to 36 months of age.
With the provisional approval of the vaccine manufactured by the Serum Institute of India, Nigeria became the second country to approve the new malaria vaccine from Oxford University after Ghana.
She declared that the agency received the dossier of the vaccine and subjected it to independent review by experts from Nigeria’s tertiary institutions and the agency’s in-house vaccine review committee and said it met the criteria for efficacy, safety, and quality.
According to her, while the review committee recognised that the vaccine is 75 per cent effective in protecting against malaria, the vaccine’s potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
The DG noted that Nigeria has the highest burden for malaria in the continent hence, having an efficacious vaccine was crucial to protect millions of children.
Prof Adeyeye said that Nigeria is expected to get at least 100,000 doses of the vaccine in donations soon before the market authorisation starts making other arrangements with the National Primary Health Care Development Agency (NPHCDA).
According to her, “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. (SIIPL).
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline.”
Professor Adeyeye, however, said with the provisional approval of the R21 Malaria Vaccine for use in Nigeria, the Agency has also communicated the need for expansion of the clinical trial in its phase 4 clinical trial/Pharmacovigilance study phase to be carried out also in Nigeria.
In a remark, Dr Babatunde Ogunbosi, a consultant paediatrician at the University College Hospital (UCH), Ibadan, said a malaria vaccine is a good tool and a welcome development that should be added to other interventions to control malaria in the country.
Director and Professor of Pediatrics and Child Health at the Institute of Child Health, University of Ibadan, Professor Adebola Orimadegun said the Oxford Malaria Vaccine is a welcome development given that more modern and potent approaches are needed for malaria eradication in Nigeria.
“We need to engage in a more modern and potent approach to malaria eradication in Nigeria; it is highly required because Nigeria is contributing so much to the malaria global burden. So it is a good thing that Nigeria has adopted it.
“Just like a vaccination against other vaccine-preventable diseases has effectively cut down deaths, I have no doubt that this also will work for our children. However, other aspects of malaria control need to be scaled up or further emphasized. For instance, we need attitudinal change if we must eradicate malaria.”
Prof Orimadegun added that there is no better time than now to approve the malaria vaccine of use in Nigeria because there is evidence for the emergence of resistance to the most potent malaria medicine, Artemisinin-based combination treatments (ACTs), currently used in Nigeria.
“Researcher is reporting a few cases of Artemisinin-resistant malaria in Nigeria, though we don’t have sufficient evidence yet.
“In our recent trial, we found that the efficacy of Artemisinin-based combination treatments (ACTs) is relatively lower compared with a new antimalarial medicine called Pyronaridine. That is not good news for us because Pyronaridine is very expensive and not yet widely available. That is why I am happy for the vaccination to begin. There is no better time than now.”
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