Onyebuchi Ezigbo in Abuja
National Agency For Food And Drug Administration And Control (NAFDAC) has granted registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted).
The vaccine is manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
Director General of NAFDAC, Prof. Mojisola Adeyeye who addressed journalists in Abuja on Monday, said that the vaccine was 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”.
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
