The R21 malaria vaccine made by India’s Serum Institute has received approval from the National Agency for Food and Drug Administration and Control.
Prof. Mojisola Adeyeye, Director General of NAFDAC revealed this at a news conference on Monday in Abuja,.
With Ghana having already approved the novel malaria vaccine produced at the University of Oxford, Nigeria is now the second nation to do so.
According to Prof. Adeyeye, children between the ages of 5 and 36 months should receive the vaccination to prevent clinical malaria.
She stated that before any arrangements with the National Primary Health Care Development Agency are made in connection with the market authorization, the nation anticipates receiving at least 100,000 doses of the vaccine in contributions.
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 Authorization 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 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”
She claimed that the vaccine’s dossier underwent two levels of independent assessment.
She stated that the NAFDAC Vaccine Advisory Committee independently reviewed the dossier using standards set by the World Health Organisation across pertinent domains, in addition to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, European Medicines Agency, scientific rigour regarding the vaccine and the context of malaria in general and Nigeria in particular, and best research and manufacturing governance.
“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.”
She claimed that the R21 malaria vaccine dossier substantially conformed with the highest international criteria against which it was bench-marked.
She claimed that the Joint Review Committee found the R21 malaria vaccine data to be reliable and to meet the standards for efficacy, safety, and quality.
Additionally, it was determined that the vaccine’s known and potential advantages outweigh its known and possible drawbacks, justifying the manufacturer’s advised use.
“The Joint Review Committee recognised the importance of an effective malaria vaccine (with 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.
“The Joint Review Committee also recommended additional phase four clinical trial, pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.
“The Joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25 per cent not covered to understand issues bothering on non-protection that could inform further research.
“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,” she noted.
According to reports, deaths from malaria occurred in four African nations: Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%), and Niger (3.9%).
97% of people in Nigeria are at risk of contracting malaria.
