The World Health Organization has approved the first malaria treatment specifically designed for babies, marking what experts describe as a major public health milestone. The decision paves the way for widespread use of the drug, Coartem Baby, across the globe, particularly in sub-Saharan Africa where the burden of malaria is highest.
Addressing a Critical Treatment Gap
In parts of Africa, up to 18% of children under six months are infected with malaria, yet historically there has been no safe treatment for the youngest infants. According to WHO data, approximately 610,000 deaths from malaria occurred in 2024, with around three-quarters of those being children under five in Africa. Until now, infants with malaria were often treated with formulations designed for older children, which increased the risk of dosing errors, side effects, and toxicity.
Coartem Baby, which can be used to treat infants weighing as little as 2kg (4.4lb), comes in sweet cherry-flavoured tablets that can be dissolved into liquids, including breast milk. The drug combines two antimalarial agents, artemether and lumefantrine, and was developed by Novartis in partnership with the Medicines for Malaria Venture (MMV).
WHO Prequalification and Global Impact
WHO prequalification indicates that Coartem Baby meets international standards of quality, safety, and efficacy. This status enables public-sector procurement for countries with high malaria rates, particularly in sub-Saharan Africa. Dr Tedros Adhanom Ghebreyesus, WHO Director General, stated: “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. But today, the story is changing.” He also highlighted that new vaccines, diagnostic tests, and next-generation mosquito nets are helping to turn the tide against the disease.
Challenging Historical Misconceptions
The development follows increasing research that challenges the historical misconception that young babies cannot contract malaria because they retain immunity passed on by their mothers during pregnancy and breastfeeding. Dr Martin Fitchet, CEO of MMV, noted: “For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind.” He described the WHO ruling as “a major public-health milestone.”
Real-World Impact: Baby Wonder's Story
The treatment has already been introduced in Ghana. Baby Wonder, now eight months old, was among the first patients to receive the drug when he was just 12 weeks old. He had been taken to hospital with a high fever, and tests confirmed elevated levels of the malaria parasite in his blood. His mother, Naomi, said: “I was very scared when my son got malaria because he was born underweight.” Doctors at the hospital managed to coordinate access to Coartem Baby, and today Wonder is healthy and thriving.
Dr Emmanuel Aidoo, a paediatrician at Methodist Hospital in Ankaase, Ghana, commented: “As doctors we have tended to look for malaria in older children, but when newborn babies got sick nobody seemed to know what to do. Having a new treatment tailor-made for infants that is well tolerated gives us confidence.”
Not-for-Profit Access and Funding
Novartis has stated that it will make Coartem Baby available “on a largely not-for-profit basis in malaria-endemic regions.” The Gates Foundation, which also contributes funding to the Guardian's Global development site, is among the donors to the Medicines for Malaria Venture.
