WHO Approves First Malaria Treatment for Babies to Reduce Child Deaths in Africa

TL;DR

\nThe World Health Organization has approved Coartem Baby, the first malaria treatment formulated specifically for infants, to fill a long-standing gap in care for newborns and young babies. The drug could help lower the share of malaria deaths among African children under five, which made up about three-quarters of the 610,000 malaria fatalities recorded in 2024.\n\nContext\nIn many parts of Africa, up to 18 % of children under six months test positive for malaria, yet no medicine had been designed for their tiny bodies. Clinicians previously used formulations meant for older children, which raised the risk of dosing errors, side effects and toxicity. The lack of an infant-specific option left the youngest patients vulnerable to severe disease and death.\n\nKey Facts\n- WHO granted prequalification to Coartem Baby, a sweet-cherry flavored tablet containing artemether and lumefantrine that can be dissolved in liquids, including breast milk, for infants weighing as little as 2 kg.\n- The approval follows data from a randomized controlled trial assessing safety and efficacy in this age group; the exact sample size was not disclosed in the source material.\n- In 2024 malaria caused 610,000 deaths globally, with roughly 75 % occurring in African children under five.\n- WHO Director-General Dr Tedros Adhanom Ghebreyesus said the new treatment marks a turning point after centuries of malaria stealing children from families.\n- The drug has already been introduced in Ghana, where a baby named Wonder received it at 12 weeks old and recovered after a high-fever episode.\n- Novartis plans to supply Coartem Baby on a largely not-for-profit basis in malaria-endemic countries, supported by partners such as the Medicines for Malaria Venture and the Gates Foundation.\n\nWhat It Means\nCaregivers in endemic areas now have a treatment that matches the physiological needs of infants, reducing the likelihood of dosing mistakes that could lead to under- or over-medication. Health workers can administer the drug with confidence, knowing it meets international quality, safety and efficacy standards. By preventing progression to severe malaria, the intervention aims to cut the proportion of under-five deaths linked to the disease. Practical steps include training clinicians on the new formulation, ensuring supply chains reach remote clinics, and monitoring outcomes to confirm real-world impact.\n\nWhat to watch next\nScale-up of Coartem Baby distribution across sub-Saharan Africa, integration with existing malaria vaccine and bed-net programs, and forthcoming data on infant mortality trends will determine whether this approval translates into measurable reductions in child deaths.