Nigeria has approved the use of a ground-breaking malaria vaccine, R21, a major decision expected to help save lives and boost the country’s fight against the killer disease.
The regulator, National Agency for Food and Drug Administration and Control (NAFDAC), announced the approval on Monday, becoming the second country in the world to do so.
The announcement came days after Pluboard began inquiring about Nigeria’s position on the Oxford-developed vaccine following Ghana’s approval last week. The agency said its decision would be made known later, before advising us of its news briefing on Monday.
In a statement, NAFDAC said it was “granting registration approval” for the vaccine after reviews conducted by its internal and external teams of experts.
“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,” it said.
“While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.”
The decision has been communicated to the health minister and the National Primary Health Care Development Agency for appropriate action towards immunization in the respective population, it said.
– Learn more
Developed by Oxford University and manufactured by the Serum Institute of India, R21, also known as Matrix-M, showed 80% protection in early trials and has been described as a “world-changer” by the scientists who developed it.
The vaccine can be used in children aged between five months and three years old. This age group is at highest risk of death from malaria. It requires three initial doses followed by a booster after one year. The vaccine is being considered for approval by the World Health Organization.
Ghana approved the vaccine after a successful large study, following a preliminary trial in Burkina Faso. The final trial covered nearly 5,000 children in Burkina Faso, Kenya, Mali and Tanzania.
The vaccine can be manufactured at mass scale and modest cost, “enabling as many as hundreds of millions of doses to be supplied to African countries” and reduce “over half a million malaria-related deaths annually,” according to the University of Oxford team behind it.
The Serum Institute of India is working on producing between 100-200 million doses per year and a vaccine factory is being built in Accra, Ghana’s capital.
– Why this matters
Malaria kills more than 600,000 people a year, most of them children in sub-Saharan Africa. Although the disease is also found in other subequatorial regions, like India, about 96% of all cases occur in Africa, WHO data shows.
Over half of those occur in Nigeria, the Democratic Republic of Congo, Uganda, Mozambique, Angola, and Burkina Faso. Malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria, NAFDAC said.
According to the 2021 World Malaria Report, Nigeria had the highest number of global malaria cases (27 % of global malaria cases) and the highest number of deaths (32 % of global malaria deaths) in 2020.The country accounted for an estimated 55.2% of malaria cases in West Africa in 2020.
The death rate from malaria has been declining for children under the age of five for the past several years, but this age group still makes up the lion’s share of the disease’s fatalities. They comprised nearly 80% of all malaria deaths in 2021, according to UNICEF.
The overall death rate from malaria dropped 40% between 2000 and 2015, according to the WHO.
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