The National Food and Drug Administration and Control (NAFDAC) has approved the R21 malaria vaccine produced by the Serum Institute, India. NAFDAC Director General, Prof. Mojisola Adeyeye made the announcement at a press conference in Abuja on Monday.
This makes Nigeria the second country after Ghana to approve a new malaria vaccine developed at Oxford University.
Professor Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from the age of 5 months to 36 months.
She said the country expects at least 100,000 doses of the vaccine in the form of donations before the market authorisation. After the authorization, then arrangements would be made with the National Primary Health Care Development Agency.
Adeyeye said –
“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.
“The Marketing Authorisation Holder 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 a ready-to-use liquid formulation for intramuscular injection.
“The vaccine is indicated for the prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”
She said the dossier of the vaccine was subjected to independent review at two levels. Also, it was reviewed by NAFDAC’s Vaccine Advisory Committee independently, using standards of the World Health Organisation across relevant domains.
She said –
“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries, and made recommendations accordingly.
“Overall, the assessment was scored as adequate, fully compliant with standards, and the report was submitted to the Director General.
“The review of NAFDAC’s committee has always been guided by the same international standards and best practices with the same modality of an independent review by members followed by long hours of plenary where a rigorous assessment of each review took place.
“The committee also independently scored the assessment as satisfactory and forwarded it to the Director General.”
Accordingly, the R21 malaria vaccine dossier complied substantially with the best international standards. These are the standards with which the dossier was benched-marked.
Four African countries accounted for just over half of all malaria deaths worldwide. At the present time, the countries include -Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%) and Niger (3.9%).
In Nigeria, 97 per cent of the population is at risk of malaria.
cc: Punch Ng
