The Federal Government has granted provisional approval for the R21/Matrix malaria vaccine developed by scientists at Oxford University.
The development comes days after Ghana became the first country to approve the vaccine — which is said to be 80 percent effective.
The malaria vaccine is manufactured by the Serum Institute of India Pvt Ltd.
Director-general of the National Agency for Food and Drug Administration and Control Mojisola Adeyeye made the announcement at a press briefing on Monday.
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).
