The National Agency for Food and Drug Administration and Control (NAFDAC) on Monday approved the provisional use of the R21 malaria vaccine.
The agency 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.
It further stated that while the review committee recognized 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.
NAFDAC said the provisional approval of the R21 malaria vaccine makes Nigeria the second country in the world to approve its use after Ghana.
While stating that the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorization will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA), NAFDAC disclosed that the vaccine is indicated for prevention of clinical malaria in children from 5 months to 36 months of age.
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 Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“The R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution. A dose which is 0.5ml is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial as ready-to-use liquid formulation for intramuscular injection.
“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline.”
