The National Agency for Food and Drug Administration and Control (NAFDAC) has granted registration approval for the R21 Malaria Vaccine manufactured by Serum Institute of India.
Briefing newsmen, in Abuja virtually, NAFDAC Director General, Professor Mojisola Adeyeye, disclosed that the R21 malaria vaccine is an Adjuvanted protein vaccine presented as a sterile solution.
Prof. Adeyeye said, the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age and guarantees 71 per cent protection.
“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 is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
The NAFDAC boss explained that the approval of the vaccine follows stringent review of the dossier of the vaccine using standards of the World Health Organization (WHO), adding that Nigeria expects 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.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline.”
With this approval, Nigeria becomes the second country after Ghana to approve the R21 malaria vaccine, which is hoped to save millions of lives in the country.
According to the WHO report, four African countries accounted for just over half of all malaria deaths worldwide with Nigeria leading with (31.3%), the Democratic Republic of the Congo (12.6%), United Republic of Tanzania (4.1%) and Niger (3.9%).
In Nigeria, 97 per cent of the population are at risk of malaria.
