Nigeria Becomes Second Country To Approve Use Of R12 Malaria Vaccine After Ghana

The National Agency for Food and Drug Administration and Control( NAFDAC)  has approved the R21 malaria vaccine manufactured by the Serum Institute of India.

Nigeria has become the second country to approve the new Oxford University developed malaria vaccine after Ghana.

 THE WHISTLER reported last Thursday that Ghana endorsed the new Oxford University R12 Malaria vaccine,  becoming the first nation in the world to approve the vaccine. The country signed a  contract with the Serum Institute of India to provide about 200 million doses yearly.

The Director General of NAFDAC, Prof Mojisola Adeyeye, made this known on Monday at a press briefing in Abuja.

According to Prof Adeyeye,  the vaccine is approved for the prevention of clinical malaria in children from 5 months to 36 months of age.

The NAFDAC boss said before the market begins to make further arrangement with the National Primary Health Care Development Agency,  Nigeria anticipates to receiving at least 100, 000 doses of the R12 malaria vaccine in donations.

She continued by saying that the agency is approving the registration of the R21 Malaria Vaccine (Recombinant, Adjuvanted), produced by Serum Institute of India Pvt. Ltd., in accordance with its authority under the NAFDAC Act CapN1, LFN 2004.

“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.”

Prof Adeyeye stated that the vaccine’s dossier underwent two levels of independent assessment by the NAFDAC Vaccine Advisory Committee independently using standards of the World Health Organization across relevant 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, and specifically to Nigeria and best governance in research and manufacturing .

 It noted that the “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.”

Furthermore,  she said the R12 malaria vaccine dossier conformed adequately with the highest international criteria against which it was benchmarked.

Prof Adeyeye also said 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 recommendation 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 said.