The R21 Malaria vaccine dossier substantially complies with the best international standards, according to Prof. Mojisola Adeyeye, Director-General of the NAFDAC, who was speaking at a briefing in Abuja on Monday. This led the Joint Review Committee to draw the conclusion that the data on the R21 Malaria vaccines were reliable and met standards for efficacy, safety, and quality.
The review committee discovered that the vaccine’s known and potential benefits outweigh its known and possible risks, supporting the manufacturer’s recommended use, even though it acknowledged that the vaccine is only 75% effective at preventing malaria.
According to her, 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.
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.”
