The World Health Organization has, for the first time, prequalified a malaria treatment specifically designed for newborns and infants, marking a significant step forward in protecting some of the world’s most vulnerable children.
The newly approved treatment, artemether-lumefantrine, is formulated for babies weighing between two and five kilograms and addresses a long-standing gap in pediatric malaria care. Previously, infants were often given medications intended for older children, increasing the risk of dosing errors, side effects, and toxicity.
According to the WHO, this prequalification confirms that the medicine meets international standards for quality, safety, and efficacy. It will allow United Nations agencies such as Gavi, the Vaccine Alliance, and UNICEF to procure and distribute the treatment in low-resource settings across Africa, where an estimated 30 million babies are born each year in malaria-endemic regions.
“This will help expand access to quality treatment for one of the most vulnerable patient groups,” the WHO stated in a press release announcing the decision.
The development has been welcomed by pharmaceutical company Novartis, which produces the pediatric formulation known as Coartem Baby. The organization said the approval represents a major advancement that could improve malaria management for millions of infants across the continent.
Malaria remains a leading cause of illness and death among young children in sub-Saharan Africa. By providing a treatment tailored to the youngest patients, health officials hope to reduce complications and improve outcomes in areas where the disease continues to pose a serious public health threat.
