The National Agency for Food and Drug Administration and Control (NAFDAC) yesterday granted registration approval for the R21 Malaria Vaccine (Recombinant, Adjuvanted).
This makes Nigeria the second nation, after Ghana, to approve the new malaria vaccine developed by the University of Oxford scientists.
Malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria.
The vaccine is indicated to prevent clinical malaria in children from five months to 36 months of age.
NAFDAC Director-General, Prof. Mojisola Adeyeye, told journalists in Abuja on Monday that the agency received the dossier of the R21 Malaria vaccine manufactured by the Serum Institute of India Pvt Ltd (SSPL), and subjected it to independent review at two levels.
They are the external advisory body—NAFDAC’s Vaccine Advisory Committee (NEVAC)—made up of 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) and the in-house NAFDAC’s Vaccine Review Committee, a multidisciplinary group extracted from different NAFDAC directorates.
She said: “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 a ready-to-use liquid formulation for intramuscular injection. The Marketing Authorization Holder’s (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.”
Adeyeye said NAFDAC had several pathways for registering vaccines, in accordance with its guidelines for registering imported drugs, vaccines, and IVDs under collaborative registration procedures or the agency guidelines for registering imported drugs and vaccines.
The R21 Malaria vaccine was reviewed using the latter which involves a full review of product dossiers, she added.
She said overall, 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,” she said.
She said while approving, the agency had also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.
She said, “The brief on the approval of the R21 Malaria vaccine has been communicated to the Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.”
According to the latest WHO World Malaria Report, there were 247 million malaria cases in 2021 compared to 245 million cases in 2020. The estimated number of malaria deaths stood at 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 63 000 more malaria deaths.
