At a press briefing in Abuja, the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, announced the approval of the R21 malaria vaccine manufactured by the Serum Institute of India. This makes Nigeria the second country to approve the vaccine, following Ghana. The vaccine is designed for the prevention of clinical malaria in children aged between 5 and 36 months, and NAFDAC expects to receive at least 100,000 doses in donations soon. The Marketing Authorization Holder for the vaccine is Fidson Healthcare Ltd in line with NAFDAC's Drug and Related Products Registration Regulation 2021. The vaccine's dossier was subjected to independent review by NAFDAC's Vaccine Advisory Committee and the Joint Review Committee, which concluded that the vaccine's data were robust and met the criteria for efficacy, safety, and quality. The known and potential benefits of the vaccine were also found to outweigh the known and potential risks. NAFDAC granted registration approval for the R21 Malaria Vaccine in line with the WHO's Malaria Vaccine Implementation Guideline.
At a press briefing in Abuja, the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, announced the approval of the R21 malaria vaccine manufactured by the Serum Institute of India. This makes Nigeria the second country to approve the vaccine, following Ghana. The vaccine is designed for the prevention of clinical malaria in children aged between 5 and 36 months, and NAFDAC expects to receive at least 100,000 doses in donations soon. The Marketing Authorization Holder for the vaccine is Fidson Healthcare Ltd in line with NAFDAC's Drug and Related Products Registration Regulation 2021. The vaccine's dossier was subjected to independent review by NAFDAC's Vaccine Advisory Committee and the Joint Review Committee, which concluded that the vaccine's data were robust and met the criteria for efficacy, safety, and quality. The known and potential benefits of the vaccine were also found to outweigh the known and potential risks. NAFDAC granted registration approval for the R21 Malaria Vaccine in line with the WHO's Malaria Vaccine Implementation Guideline.