The World Health Organization has prequalified the first malaria treatment specifically for newborns and young infants, clearing the way for broader public-sector use globally. In some parts of Africa, as many as 18% of children under six months are infected with malaria, and in 2024 there were 610,000 malaria deaths worldwide, about three-quarters of them among children under five in Africa.
Until now, infants with malaria were treated with formulations intended for older children, increasing the risk of dosing mistakes, side effects and toxicity. Coartem Baby, approved for infants from 2 kg (4.4 lb), is a sweet cherry‑flavoured tablet that dissolves in liquids, including breast milk, making administration easier for caregivers. The WHO’s prequalification signals the product meets international standards of quality, safety and efficacy and will enable procurement for many high-burden countries, particularly in sub‑Saharan Africa.
Coartem Baby combines the antimalarial drugs artemether and lumefantrine and was developed by Novartis in partnership with the Medicines for Malaria Venture (MMV). Its approval follows research overturning the long-held belief that young infants are protected from malaria by maternal immunity passed during pregnancy and breastfeeding.
WHO director‑general Dr Tedros Adhanom Ghebreyesus said the approval marks a change in the fight against a disease that has long robbed families and communities of children and hope. MMV chief executive Dr Martin Fitchet called the ruling “a major public‑health milestone,” noting newborns and young infants had previously been left without treatments designed for them. Dr Fitchet and other public‑health leaders point to new vaccines, improved diagnostic tests and next‑generation mosquito nets as part of progress against malaria.
The treatment has already been rolled out in Ghana. Baby Wonder, now eight months old, received the drug at 12 weeks when tests found high parasite levels after a fever. His mother, Naomi, said she was terrified because he had been born underweight; after receiving Coartem Baby, Wonder recovered and is thriving. Paediatrician Dr Emmanuel Aidoo of Methodist Hospital in Ankaase, Ghana, said clinicians often focused on older children and lacked options for sick newborns; a well‑tolerated, infant‑tailored treatment gives them more confidence.
Novartis said it will provide Coartem Baby largely on a not‑for‑profit basis in malaria‑endemic regions.
The Gates Foundation, which contributes funding towards the independent journalism produced on the Guardian’s Global development site, is also among the donors to the Medicines for Malaria Venture
