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.
The agency said the action was part of its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.
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. “
She said the R21 Malaria Vaccine was reviewed using the later which involves full review of product dossiers.
Speaking on the dossier review,she said:”NAFDAC received the dossier of the R21 Malaria manufactured by the Serum Institute of India Pvt Ltd (SSPL) and was subjected to independent review at two levels.
“As a matured regulatory agency, it is expected as part of global benchmarking that external advisory committee is in place to advise upon invitation on certain functions of the agency.
“As a new biological molecule that is being given consideration for full registration, the independent review by an external body becomes imperative as a means to further safeguard public health.”
Vanguard