On the eve of World Malaria Day 2026, the World Health Organization (WHO) has announced two major advances in the fight against malaria: the prequalification of Coartem® (artemether-lumefantrine) Baby, the first-ever antimalarial treatment developed specifically for newborns and infants, and the approval of three new rapid diagnostic tests (RDTs) to address a growing detection crisis in Africa.
Until now, babies with malaria have been treated with drugs designed for older children, a workaround that increased the risk of dosing errors, side effects, and even toxicity. This is especially alarming since children under five account for more than two-thirds of malaria deaths globally, with almost three in four deaths in the region occurring in this age group. Every year, about 30 million babies are born in malaria-risk areas in Africa, and in West Africa alone, infection rates among infants younger than six months can range from 3.4% to 18.4%. Yet, newborns have rarely been included in clinical trials for malaria drugs—until now.
Malaria Diagnosis Crisis in Africa
Recent studies across 46 countries have revealed that some malaria parasites have evolved, shedding the gene necessary for detection by standard HRP2-based RDTs. In countries in the Horn of Africa, up to 80% of cases were missed, leading to delayed treatment, severe illness, and rising mortality rates. The newly approved rapid tests target a different parasite protein—pf-LDH—which malaria parasites cannot easily shed. This provides a reliable, quality-assured alternative, ensuring accurate diagnosis and timely treatment even where traditional tests fail.
What This Means for Vulnerable Infants
The approval of Coartem Baby by WHO means that, for the first time, countries can authorize an infant-specific malaria drug without conducting their own clinical trials—a critical step for regions lacking research resources. UN agencies can now procure and distribute the treatment in malaria-endemic areas, subject to local government approval. Novartis, the manufacturer, has committed to making the treatment available on a largely not-for-profit basis in these regions. “Having a new treatment tailor-made for infants that is well tolerated gives us confidence,” said Dr. Emmanuel Aidoo, a pediatrician in Ghana.
These innovations, coupled with new vaccines, next-generation mosquito nets, and sustained investment, are helping to turn the tide against malaria. As Dr. Martin Fitchet, CEO of MMV, put it, “WHO prequalification of Coartem Baby is a major public health milestone and reflects a commitment to ensuring that even the smallest and most vulnerable patients are not left behind.” With malaria still claiming hundreds of thousands of young lives each year, these advances offer new hope for families across Africa and beyond.
