WHO prequalifies first-ever malaria treatment for newborns and infants, adds new diagnostic tests

WHO
Apr 24, 2026

WHO prequalifies first-ever malaria treatment for newborns and infants, adds new diagnostic tests


Ahead of World Malaria Day on 25 April, the World Health Organization (WHO) has announced a significant step forward in the fight against malaria with the prequalification of the first treatment developed specifically for newborns and young infants weighing between two and five kilograms. The prequalification designation indicates that the medicine meets international standards of quality, safety and efficacy, and will help to expand access to quality-assured treatment for one of the most underserved patient groups.

The newly prequalified treatment, artemether-lumefantrine, is the first antimalarial formulation designed specifically for the youngest malaria patients. Until now, infants with malaria have been treated with formulations intended for older children, which increase the risk of dosing errors, side effects and toxicity. WHO prequalification will enable public sector procurement, contributing to closing a long-standing treatment gap for some 30 million babies born each year in malaria-endemic areas of Africa.