The National Agency for Food and Drug Administration and Control (NAFDAC) has granted an approval to Serum Institute Pvt. Ltd. (SIIPL) for the use of the R21 malaria vaccine in the country.
At a news conference on Monday, NAFDAC Director-General Mojisola Adeyeye said the granting of registration/approval was in line with the agency’s mandate as stipulated by its enabling law — NAFDAC Act CapN1, Law of the Federation of Nigeria (LFN) 2004.
She said the Marketing Authorisation Holder (MAHs) for the vaccine is Fidson Healthcare Ltd, which had the agency’s Drug and Related Products Registration Regulation 2021.
According to Ms Adeyeye, the R21 malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.She explained 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 a ready-to-use liquid formulation for intramuscular injection.’’
The NAFDAC boss said that the vaccine is indicated for preventing clinical malaria in children from five to 36 months, adding that the storage temperature of the vaccine is 2-8 °C.
Ms Adeyeye said the agency received the dossier of the R21 Malaria manufactured by SIIPL and subjected it to independent review at two different levels.
She said that as a matured regulatory agency, it is expected as part of global benchmarking that an external advisory committee was put in place to advise on invitations on certain functions of the agency.
She said that as a new biological molecule being considered for full registration, the independent review by an external body became imperative to safeguard public health further.
According to her, the external advisory body known as NAFDAC’s Vaccine Advisory Committee (NEVAC) comprises four highly recognised and well-published experts from Nigeria’s tertiary institutions.
Ms Adeyeye said the agency also had an in-house Vaccine Review Committee (NEVAC) extracted from different directorates of NAFDAC to oversee, evaluate, and carry out clinical trials on vaccines before approval was made.
She said that the R21 Malaria Vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.
The NAFDAC boss said it became necessary to approve the vaccine following the 2021 World Malaria Report that Nigeria had the highest number of global malaria cases of 27 per cent.
She said the highest number of deaths stood at 32 per cent of global malaria deaths in 2020, adding that Nigeria accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.
“Malaria is one of the most important public health concerns in the world. The latest World Health Organization (WHO) Malaria Report showed there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020,” she said.
She explained that the estimated number of malaria deaths was 619,000 in 2021 compared to 625,000 in 2020.
“Over the two peak years of the pandemic (2020–2021), COVID-related disruptions led to about 13 million more malaria cases and 63000 more malaria deaths.
“Children under five years of age accounted for about 80 per cent of all malaria deaths in the region.
Four African countries accounted for just over half of all malaria deaths worldwide, with Nigeria, 31.3 per cent; the Democratic Republic of the Congo, 12.6 per cent; the United Republic of Tanzania, 4.1 per cent; and Niger, 3.9 per cent, respectively.”
