Kenya is among eight African countries that have taken part in clinical trials for a newly approved malaria treatment specifically formulated for newborns. This treatment, named Coartem Baby (artemether-lumefantrine), marks a significant advancement in the battle against malaria among the most vulnerable age group infants. Other participating nations in the trials include Nigeria, the Democratic Republic of Congo, Burkina Faso, Mali, and Zambia.
Coartem Baby is the first malaria drug developed for newborns and young infants weighing between two and under five kilogrammes. It is a flavoured, dissolvable powder designed to be mixed with breast milk, making it easier for babies to ingest. This child-friendly formulation addresses a long-standing gap in malaria treatment, where infants were often administered drugs meant for older children or adults, posing risks of improper dosing and potential toxicity.
The treatment is tailored to combat infections caused by Plasmodium falciparum and mixed infections in babies, based on new dosage ratios validated through extensive Phase II and III studies. Until now, no approved antimalarial treatment existed for infants under 4.5 kg. As a result, healthcare providers were forced to adapt existing formulations without adequate safety data, leaving newborns especially vulnerable.
This initiative was developed through collaboration between pharmaceutical and public health partners, aiming to make the drug accessible and affordable across malaria-endemic regions. Distribution is planned on a largely not-for-profit basis, ensuring that even the poorest communities can benefit. Swift national approvals are expected under a fast-track regulatory process established for global health products.
Each year, roughly 30 million babies are born in malaria-risk zones across Africa. Infection rates in infants under six months of age can range from 3.4% to 18.4% depending on the region. The introduction of a safe, effective, and easy-to-administer treatment for this age group is a major milestone.
In Kenya, where 75% of the population is at risk of malaria, the disease continues to cause a heavy burden. Recent figures estimate up to 10,700 deaths annually, most among children under five, and around 3.5 million clinical cases each year. The availability of Coartem Baby is seen as a vital addition to the arsenal against malaria, particularly in reducing child mortality and ensuring safer treatment options for newborns.
