Nigeria’s government (FGN) has granted provisional approval for the Malaria Vaccine, R21/Matrix developed by scientists at Oxford University for use in the country.
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.
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).
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. (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.”
The NAFDAC boss, 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.
Confiance News also gathered that Nigeria, however became the second country to approve the new malaria vaccine from Oxford University after Ghana.
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