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The National Agency for Food and Drug Administration and Control (NAFDAC), has given provisional approval for the use of the R21 malaria vaccine for the prevention of clinical malaria in children from 5 to 36 months of age.
With this approval, Nigeria becomes the second country to approve the vaccine
manufactured by the Serum Institute of India, after Ghana.
The Director-General of NAFDAC, Prof Christianah Adeleye who made the disclosure on Monday in Abuja, noted that Nigeria expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation would start making other arrangements with the National Primary Health Care Development Agency (NPHCDA).
Adeyeye who explained that the review committee recognised that the vaccine was 75 per cent effective in protecting against malaria and that its potential benefits outweigh its known and potential risks, added that the storage temperature of the vaccine was 2-8 °C.
According to her, NAFDAC was committed to ensuring that only products that were safe, of high quality, and efficacy would always be made available for Nigerians.
She said: “NAFDAC has several pathways for registration of vaccines. These pathways are in line with the Agency’s guidelines for the registration of Imported Drugs, Vaccines, and IVDs under a Collaborative Registration Procedure, or the Agency’s guideline for registration of imported Drugs and Vaccines.
“The R21 Malaria Vaccine was reviewed using the latter which involves a full review of product dossiers
“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.
“While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.
“The brief on the approval of the R21 Malaria vaccine has been communicated to the Honourable Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.”
The NAFDAC boss while stating that Malaria was one of the most important public health concerns in the world, quoted the latest WHO World Malaria Report which showed that there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020, even as the estimated number of malaria deaths stood at 619 000 in 2021 compared to 625 000 in 2020.
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