The Nigerian government has approved a new vaccine against malaria University of OxfordMaking it the second country in the world to give approval after Ghana.
The vaccine- R21/Matrix-M has been developed by the University of Oxford and is manufactured by the Serum Institute of India.
The Director-General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), Mojisola Adeyeye, disclosed the development on Monday in Abuja.
Similar to Ghana, Ms Adeyeye said the vaccine is indicated to prevent malaria in children aged 5 to 36 months.
He added that Nigeria expects to receive at least 100,000 doses of the vaccine in donations before the first market authorization can be made with the National Agency for Health Development.
Fighting Malaria
The R21/Matrix-M vaccine is the second to be approved by the WHO and the first to exceed the 75% efficacy threshold at 12 months of follow-up.
The vaccine showed a 77 percent protective efficacy over 12 months in a phase 2b study involving young children in West Africa, following three initial doses of injections.
The first malaria vaccine, RTS, S or mosquirix, from British drugmaker GSK, was approved by the WHO in 2021 after decades of work. But a lack of funding and commercial potential thwarted the company’s ability to produce enough doses.
Several studies also show that the effectiveness of GSK’s vaccine is approximately 60 percent, and that it declines significantly over time, even with a booster dose.
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When the mosquito vaccine was approved, the WHO said it was based on the results of an ongoing pilot program in Ghana, Kenya and Malawi, which has reached more than 800,000 children since 2019.
He added that he recommends the widespread use of the vaccine, “among children in sub-Saharan Africa and other regions with moderate or high transmission of plasmodium falciparum malaria.
Evaluation of NAFDAC
Speaking further, Mrs. Adeyeye said, “In accordance with the provisions of its enabling law for NAFDAC to fulfill its mandate, the NAFDAC Act CapN1, LFN 2004, grants registration approval for R21 Malaria Vaccine manufactured by Serum Institute of India Pvt. Ltd.
“The marketing authorization holder is Fidson Healthcare Ltd under the Agency’s Drug and Related Products Registration Regulations 2021.”
According to him, the R21 malaria vaccine dossier met the best international standards.
He said NAFDAC’s Vaccine Advisory Committee conducted independent evaluations of the dossier against WHO standards and other guidelines.
He said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were strong and met criteria for efficacy, safety and quality.
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