The National Agency for Food and Drug Administration Control, NAFDAC, has granted registration approval for the R21 Malaria Vaccine (Recombinant, Adjuvanted), manufactured by Serum Institute of India Limited.
NAFDAC Director General, Prof. Mojisola Adeyeye, who announced the approval at a news conference, in Abuja on Monday, noted that Malaria is one of the most important public health concerns in the world.
She explained that the R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution,adding that 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, she further explained, is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
Adeyeye 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.”
Noting that NAFDAC has several pathways for registration of vaccines, Prof. Adeyeye explained that,”These pathways are in line with the agency’s guideline for registration of imported drugs, vaccines and IVDs under Collaborative Registration Procedure, or the agency’s guideline for registration of imported drug and vaccines. “
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