Malaria continues to exact a heavy toll, especially across sub-Saharan Africa. In some areas, up to 18% of infants under six months are infected. Globally, the disease claimed about 610,000 lives in 2024, with nearly three-quarters of those deaths occurring among children under five in Africa.
Until now, infants have been treated using medications formulated for older children—a workaround that carried risks. The WHO noted that such practices “increase the risk of dosing errors, side effects and toxicity.”
A Treatment Designed for the Smallest Patients
The newly approved drug, Coartem Baby, is expected to transform care for this vulnerable group. Suitable for babies weighing as little as 2kg (4.4lb), it comes in sweet cherry-flavoured tablets that can be dissolved in liquids, including breast milk—making it easier to administer.
Containing a combination of artemether and lumefantrine, the treatment was developed by Novartis in partnership with the Medicines for Malaria Venture.
The drug has received WHO prequalification, confirming it meets international standards for quality, safety, and effectiveness. This status also enables governments and public health agencies in high-burden countries to procure it more easily.
A Turning Point in the Fight Against Malaria
Welcoming the development, WHO Director-General Tedros Adhanom Ghebreyesus said, “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. But today, the story is changing.”
He added that advances such as vaccines, improved diagnostic tools, and next-generation mosquito nets are helping shift the fight against the mosquito-borne disease.
The approval also reflects evolving scientific understanding. For years, it was widely believed that very young babies were protected from malaria by immunity passed from their mothers during pregnancy and breastfeeding. However, growing research has disproved this assumption, showing that newborns can indeed become infected.
Closing a Critical Treatment Gap
According to Martin Fitchet, “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’s decision as “a major public-health milestone.”
Healthcare professionals on the frontlines are already seeing the impact. The treatment has been introduced in Ghana, where one of the first recipients, an infant named Wonder, received the drug at just 12 weeks old after being hospitalised with a high fever and confirmed malaria infection.
His mother, Naomi, recalled, “I was very scared when my son got malaria because he was born underweight.” Following treatment, the child has since recovered and is now healthy.
Dr Emmanuel Aidoo, a paediatrician at a Methodist hospital in Ankaase, noted a shift in clinical confidence: “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.”
Expanding Access and Affordability
Novartis has announced plans to supply the drug on a largely not-for-profit basis in malaria-endemic regions, a move expected to improve access for low-income countries.
Support for the initiative has also come from global health funders, including the Bill & Melinda Gates Foundation, which is among the donors backing the Medicines for Malaria Venture.
A New Chapter in Child Health
The approval of Coartem Baby represents more than just a new drug—it signals a shift toward more inclusive, age-appropriate healthcare solutions. For decades, the youngest malaria patients were overlooked. Now, with a treatment designed specifically for them, millions of lives could be saved.
As global efforts intensify, this breakthrough offers renewed hope that one of the world’s deadliest diseases can be brought under control—starting with its most vulnerable victims.