The R21 Malaria Vaccine has received registration approval from the National Agency for Food and Drug Administration and Control (NAFDAC) (Recombinant, Adjuvanted). The company Serum Institute of India Pvt. Ltd. produces the vaccine (SIIPL).
At a Monday press conference in Abuja, Prof. Mojisola Adeyeye, the director general of NAFDAC, stated that the vaccine was recommended for use in preventing clinical malaria in children between the ages of 5 and 36 months. The vaccination should be stored between 2 and 8 °C.
She said: The National Agency for Food and Drug Administration and Control (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’s (MAHs) 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 prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C”.
More details later
