The R21 malaria vaccine produced by the Serum Institute of India has received approval from the National Agency for Food and Drug Administration and Control.
Nigeria now joins Ghana as the second nation to accept the novel malaria vaccine created by the University of Oxford.
At a news conference in Abuja on Monday, April 17, Prof. Mojisola Adeyeye, Director General of NAFDAC, revealed this.
According to Prof. Adeyeye, the vaccine is recommended for use in children between the ages of 5 and 36 months to prevent the development of clinical malaria.
She stated that before the market authorization will begin making further arrangements with the National Primary Health Care Development Agency, the nation anticipates receiving at least 100,000 doses of the vaccine in contributions shortly.
Adeyeye stated, “NAFDAC is providing registration permission for R21 Malaria Vaccine (Recombinant, Adjuvanted) made by Serum Institute of India Pvt. Ltd. as part of its mandate as outlined by NAFDAC Act CapN1, LFN 2004.
According to the Agency’s Drug and Related Products Registration Regulation 2021, Fidson Healthcare Ltd. is the holder of the marketing authorization.
“The R21 Malaria vaccine is a protein vaccine that has been adjuvanted and is given as a sterile solution. R21 Malaria Antigen 5g and Matrix-M1 50g as an adjuvant are combined in a 0.5ml dosage to provide a ready-to-use liquid formulation for intramuscular injection.
“The vaccine is recommended for use in children between the ages of 5 and 36 months for the prevention of clinical malaria. The vaccination should be stored between 2 and 8 °C.
She claimed that the vaccine’s dossier underwent two layers of independent assessment.
The vaccine dossier was evaluated by NAFDAC’s Vaccine Advisory Committee independently using World Health Organization standards across pertinent domains, in addition to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, European Medicines Agency guidelines, scientific rigor on the vaccine and the context of malaria in general and Nigeria in particular, and best research and manufacturing governance.
Adeyeye stated, Using best review practices, NEVAC members independently reviewed each section. They then physically met in plenary to evaluate and discuss the sections’ reviews, ask questions, and make recommendations.
“The assessment was given an overall score of adequate, indicating that it met all standards, and the report was sent to the Director General.
“The review of NAFDAC’s Committee has always followed the same international standards and best practices, with members conducting an independent review followed by long hours of plenary, where each review was rigorously evaluated. Additionally, the Committee independently awarded the evaluation a satisfactory score and sent it to the Director General.
She asserted that the R21 malaria vaccine dossier was substantially compliant with the highest international standards that were bench-marked for the dossier.
She stated that the Joint Review Committee came to the conclusion that the R21 Malaria vaccine’s data were reliable and met the quality, safety, and efficacy requirements.
Additionally, the vaccine’s known and potential benefits were deemed to outweigh its known and potential drawbacks, supporting the manufacturer’s recommendation for use.
“An effective malaria vaccine that provides 75% protection was recognized by the Joint Review Committee as an additional interventional tool as a critical need in Nigeria, which has the highest malaria burden.
“Given the peculiar and heterogeneous nature of malaria in Nigeria, the Joint Review Committee also recommended an additional phase four clinical trial and pharmacovigilance study for implementation in the country.
“The Joint Review Committee was also interested in reviewing data regarding the human-malaria parasite dynamics of the 25% of patients who were not covered in order to comprehend concerns regarding non-protection that may serve as a basis for subsequent research.
She mentioned that “a provisional approval of the R21 Malaria Vaccine was recommended” and that this would be carried out “in accordance with the Malaria Vaccine Implementation Guideline of the WHO.”
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