NAFDAC Gives Approval for Use of R21 Malaria Vaccine in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the provisional use of the R21 malaria vaccine in Nigeria.

With the approval of the vaccine manufactured by the Serum Institute of India, Nigeria becomes second country to approve the product after Ghana.

Speaking on the issue during a media briefing on Monday, the Director General of the Agency, Prof Christianah Adeleye,  noted that the R21 Malaria vaccine dossier complies substantially with the best international standards, which made the Joint Review Committee conclude that the data on the R21 Malaria vaccines were robust and met criteria for efficacy, safety, and quality.

She further stated that while the review committee recognised that the vaccine is 75 percent effective in protecting against malaria, it also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.

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Adeleye explained that the  provisional approval of the R21 makes Nigeria the second country in the world to approve its use after Ghana. She added that Nigeria expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA), NAFDAC.

She said the vaccine is indicated for prevention of clinical malaria in children from 5 months to 36 months of age.  The storage temperature of the vaccine is 2-8 °C.

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