WHO Approves World’s First Malaria Treatment Designed Specifically for Newborn Babies
For decades, the youngest and most defenceless victims of malaria had no treatment made specifically for them. Doctors worked with what they had, drugs designed for older children and adults, adjusted as best they could and administered to babies who were far too small for the doses involved.
That gap in medicine, one that had existed for as long as malaria itself had been treated, was closed this week. The World Health Organisation(WHO) formally approved the first antimalarial drug ever developed specifically for newborns and very young infants.
The treatment, known as Coartem Baby and developed by pharmaceutical company Novartis in partnership with the Medicines for Malaria Venture, is a carefully formulated combination of two proven antimalarial compounds, artemether and lumefantrine, redesigned from the ground up for babies weighing between two and five kilograms.
That weight range covers the most critical and vulnerable window of a newborn’s early life. Until this approval, no licensed antimalarial existed for babies in that weight category.
Infants who contracted malaria were treated with medicines intended for larger, older children, a practice that carried real risks of incorrect dosing and toxic side effects.
Paediatricians in malaria-heavy regions described the situation as one where nobody quite knew what to do when the smallest babies fell sick.
The WHO’s move to prequalify the drug is more than symbolic. It clears the path for governments across malaria-endemic countries to approve and adopt the treatment within their health systems.
It also allows United Nations procurement agencies to purchase and distribute it directly to the areas that need it most, particularly across sub-Saharan Africa, where the disease remains most deadly.
The timing of the announcement carries weight. The approval came just ahead of World Malaria Day on April 25, as the WHO and its global partners launched this year’s campaign under the rallying theme: the world now has the tools to end malaria, and must use them.
The numbers behind that urgency are sobering. According to the most recent WHO global malaria report, the disease killed 610,000 people in 2024, a figure higher than the year before.
Children under the age of five account for roughly three out of every four malaria deaths across Africa. Thirty million babies are born in malaria-risk zones on that continent every year.
Ghana is already ahead of the curve. Novartis introduced Coartem Baby there before the formal WHO prequalification, meaning some of the smallest patients have already begun benefiting.
The company has committed to making the treatment available on a largely not-for-profit basis across malaria-endemic countries, a move public health advocates welcomed as essential given that most affected families have little ability to pay market prices for medicine.
WHO Director for Malaria and Neglected Tropical Diseases described the new formulation as a genuine innovation, one that fills a gap that should never have existed as long as it did.
For the babies born into the regions most ravaged by this ancient disease, it represents something their parents and grandparents never had: a medicine made exactly for them. #WHO Approves World’s First Malaria Treatment Designed Specifically for Newborn Babies#
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