The vaccine is manufactured by the Serum Institute of India Limited.
This action aligns with NAFDAC’s mandate stipulated by its enabling law, the NAFDAC Act CapN1, LFN 2004.
Prof. Mojisola Adeyeye, the Director General of NAFDAC, announced the approval at a news conference in Abuja on Monday, stating that Malaria is one of the world’s most significant public health concerns.
She explained that the R21 Malaria Vaccine is indicated for preventing clinical Malaria in children from 5 months to 36 months of age.
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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 Holders (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 the registration of vaccines, Prof. Adeyeye explained, “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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She said the R21 Malaria Vaccine was reviewed using the latter, which involves a 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 mature regulatory agency, it is expected, as part of global benchmarking, that an 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.”
