BREAKING: Nigeria becomes second country to approve R21 malaria vaccine

Nigeria makes history becomes second country to approve R21 malaria vaccine as NADFDAC gives nod

 

 

The National Agency for Food and Drug Administration and Control has approved the Serum Institute of India’s R21 malaria vaccine.

 

Prof. Mojisola Adeyeye, director general of NAFDAC, disclosed this on Monday at a press briefing in Abuja.

 

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This makes Nigeria the second country, after Ghana, to approve the new malaria vaccine developed at Oxford University.

 

Prof. Adeyeye stated that the vaccine is recommended for preventing clinical malaria in children aged 5 to 36 months.

 

She stated that the country anticipates receiving at least 100,000 doses of the vaccine through donations before the National Primary Health Care Development Agency will begin making other arrangements.

 

Adeyeye stated, “NAFDAC is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. in accordance with its enabling legislation, the NAFDAC Act CapN1, LFN 2004.

 

“Fidson Healthcare Ltd is the Marketing Authorization Holder in accordance with the Agency’s Drug and Related Products Registration Regulation 2021.

 

“The R21 Malaria vaccine is a protein vaccine adjuvanted with a sterile solution. A dose of 0.5ml consists of R21 Malaria antigen 5g and adjuvant Matrix-M1 50g in a vial as a ready-to-use liquid formulation for intramuscular injection.

 

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“The vaccine is recommended for the prevention of clinical malaria in children aged 5 to 36 months.” The vaccine must be stored at a temperature between 2 and 8 degrees Celsius.”

 

She stated that the dossier for the vaccine underwent two levels of independent review.

 

She stated that the dossier was reviewed independently by NAFDAC’s Vaccine Advisory Committee using World Health Organization standards across relevant domains, as well as International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria in Nigeria, and best research and manufacturing governance.

 

“NEVAC members reviewed all sections independently using best review practises and convened in plenary to evaluate and debate the reviews by section, raise questions, and make recommendations based on their findings.

 

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