The National Agency for Food and Drug Administration and Control has approved the R21 malaria vaccine manufactured by the Serum Institute of India.
The Director General of NAFDAC, Mojisola Adeyeye, disclosed this on Monday at a news conference, in Abuja.
This makes Nigeria the second country to approve the new malaria vaccine developed at the University of Oxford, after Ghana.
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 DG noted that Malaria is one of the most important public health concerns in the world.
Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
She said the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.
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.”
She said the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee independently using standards of the World Health Organisation across relevant domains, in addition to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria and specifically to Nigeria and best research and manufacturing governance.
“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.”
According to her, the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.
She said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.
It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
Adeyeye also noted that “A provisional approval of the R21 Malaria Vaccine was recommended, and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline.”
