By Hassan Zaggi
The National Agency for Food and Drug Administration and Control (NAFDAC) has given approval for the use of R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
Speaking at a media briefing in Abuja, Monday, the Director General of NAFDAC, Prof. Mojisola Adeyeye, disclosed that the vaccine is indicated for prevention of clinical malaria in children from 5 to 36 months of age.
The Marketing Authorization Holder’s (MAHs), she revealed, is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
According to the NAFDAC Director General: “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 storage temperature of the vaccine is 2-8 °C.”
Prof. Adeyeye further noted that NAFDAC has several pathways for registration of vaccines.
“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.
“The R21 Malaria Vaccine was reviewed using the later which involves full review of product dossiers.
Dossier Review
“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 advice 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.
“The external advisory body – NAFDAC’s Vaccine Advisory Committee (NEVAC) is made up of four highly recognized, well-published experts from Nigeria’s tertiary institutions (Nnamdi Azikwe University, Awka, Anambra State; University of Lagos, Lagos State, University of Ibadan, Oyo State and Usman Dan Fodio University, Sokoto, Sokoto State).
“The in-house NAFDAC’s Vaccine Review Committee is a multi-disciplinary group extracted from the following NAFDAC directorates – Drug Registration and Regulatory Affairs, Vaccines/Biologics/Medical Devices; Drug Evaluation and Research (for Clinical trial/Good Manufacturing Practices inputs; Pharmacovigilance; Post-Marketing Surveillance, Central Drug Control Laboratory, and Port Inspection.
Essentially, the dossier was reviewed by NEVAC independently using standards of the World Health Organization (WHO) across relevant domains, in addition to the ICH guidelines, European Medicines Agency guidelines (where appropriate), scientific rigor on the vaccine and the context of malaria generally and specifically to Nigeria and best research and manufacturing governance.”
