The Nigerian government has approved a new malaria vaccine R21/Matrix-M, from Oxford University, becoming the second country after Ghana in the world to grant such approval, vaccine manufactured by the Serum Institute of India.
Penpushing reports that Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Mojisola Adeyeye, made this known on Monday in Abuja, Federal Capital Territory (FCT)
The Director General similar to Ghana, said the vaccine is indicated for the prevention of malaria in children from 5 months to 36 months of age, adding that Nigeria expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.
Penpushing further reports that R21/Matrix-M vaccine is the second ever to be approved by the World Health Organisation(WHO) and the first to exceed the World Health Organisation(WHO) threshold of 75 per cent efficacy over 12 months of follow-up.
The vaccine showed a 77 per cent protective efficacy over 12 months in a phase 2b trial involving young West African children, following an initial three-dose course of injections, while the first-ever malaria vaccine, RTS, S or mosquirix, from British drugmaker GSK, was approved by the World Health Organisation(WHO) in 2021 after decades of work.
Penpushing also reports that a lack of funding and commercial potential thwarted the company’s capacity to produce as many doses as were needed, while various research equally shows that the effectiveness of GSK’s vaccine is approximately 60 per cent, and significantly wanes over time, even with a booster dose.
The World Health Organisation(WHO), when the mosquirix vaccine was approved, said it was based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019.
Penpushing reports that it added that it recommends widespread use of the vaccine, among children in sub-Saharan Africa and other regions with moderate to high plasmodium falciparum malaria transmission.
“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”, Adeyeye said
Penpushing further reports that she noted that, the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was bench-marked, stressing that the dossier was subjected to independent reviews by National Agency for Food and Drug Administration and Control (NAFDAC’s) Vaccine Advisory Committee according to WHO standards, and other guidelines.
Meanwhile, the Director General said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.
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