The National Agency for Food and Drug Administration and Control has approved the R21 malaria vaccine manufactured by the Serum Institute of India.
According to The PUNCH, the Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Monday at a press briefing in Abuja.
Speaking during a briefing in Abuja, the Director-General of the NAFDAC, Prof. Mojisola Adeyeye 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 approval makes Nigeria the second country to approve the new malaria vaccine developed at the University of Oxford, after Ghana.
Prof Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
She said the country 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.
Adeyeye 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.
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
