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NAFDAC Gives Approval to Malaria Vaccine.
NAFDAC gives approval to malaria vaccine.
The National Agency for Food and Drug Administration and Control (NAFDAC) has granted registration approval for the R21 malaria vaccine (recombinant, adjuvanted).
The vaccine is manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
The Director General of NAFDAC, Prof. Mojisola Adeyeye, who addressed journalists in Abuja on Monday, said that the vaccine was indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. NewsReport gathered.
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, the NAFDAC Act, Cap. 1, LFN 2004, is granting registration approval for the R21 malaria vaccine (recombinant, adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
The marketing authorization holder’s (MAH’s) 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 of 0.5 mL is composed of R21 malaria antigen 5 g and Matrix-M1 50 g as an adjuvant, and it is filled in a vial as a 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.
