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WHO Prequalifies First Malaria Treatment for Newborns

Published 25 April 2026

The World Health Organization announced on Friday the prequalification of the first malaria treatment specifically designed for newborns and young infants, a milestone aimed at protecting one of the disease's most vulnerable groups in malaria-endemic regions.

The treatment, a formulation of artemether-lumefantrine, targets babies weighing between two and five kilograms. Previously, infants with malaria—a mosquito-borne disease—received medications intended for older children, raising risks of dosing errors, side effects, and toxicity, according to WHO officials. The prequalification confirms the medicine meets international standards for quality, safety, and efficacy, facilitating public sector procurement and broader access. This addresses a critical gap for approximately 30 million babies born annually in malaria-endemic areas of Africa, where children under five account for nearly 75 percent of malaria deaths in the WHO Africa region.

The approval comes ahead of World Malaria Day on April 25, as global efforts against the disease face both progress and setbacks. In 2024, WHO estimated 282 million malaria cases and 610,000 deaths worldwide, an increase from the previous year....

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