The World Health Organization (WHO) has approved the first malaria treatment specifically designed for babies, marking what health officials describe as a major public health milestone. The prequalification of Coartem Baby means that newborns as small as 2 kilograms (4.4 pounds) can now be safely treated for malaria, rather than relying on formulations intended for older children.
Addressing a Critical Gap
In parts of Africa, up to 18% of children under six months are infected with malaria, yet there has historically been no safe treatment for the youngest patients. In 2024, malaria caused 610,000 deaths globally, with about three-quarters occurring in children under five in Africa. The WHO noted that until now, infants were treated with drugs designed for older children, increasing the risk of dosing errors, side effects, and toxicity.
Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, said: "For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. But today, the story is changing."
How Coartem Baby Works
Coartem Baby contains two antimalarial drugs—artemether and lumefantrine—and comes as sweet cherry-flavored tablets that can be dissolved in liquids, including breast milk. Developed by Novartis in partnership with the Medicines for Malaria Venture (MMV), the drug now has WHO prequalification, ensuring it meets international standards of quality, safety, and efficacy. This will enable public-sector procurement in malaria-endemic countries, particularly in sub-Saharan Africa.
The approval follows research challenging the misconception that young infants are protected by maternal immunity. Dr. Martin Fitchet, CEO of MMV, said: "For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind. This is a major public health milestone."
Early Success in Ghana
Coartem Baby has already been introduced in Ghana, where Baby Wonder—now eight months old—was among the first recipients at 12 weeks old. He was hospitalized with a high fever and tested positive for malaria. His mother, Naomi, said: "I was very scared when my son got malaria because he was born underweight." Thanks to the new drug, Wonder is now healthy and thriving.
Dr. Emmanuel Aidoo, a pediatrician at Methodist Hospital in Ankaase, Ghana, added: "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."
Broader Efforts Against Malaria
Ghebreyesus highlighted that new vaccines, diagnostic tests, and next-generation mosquito nets are helping to turn the tide against the mosquito-borne disease. Novartis stated it would make Coartem Baby available on a largely not-for-profit basis in malaria-endemic regions. The Gates Foundation, a donor to MMV, also supports this initiative.
