WHO Approves Infant Malaria Therapy, Introduces Additional Diagnostic Tests
A quiet breakthrough for the tiniest patients is reshaping the fight against malaria.
Just days after World Malaria Day on April 25, the World Health Organization announced a major milestone: the first-ever malaria treatment specifically designed for newborns and young infants weighing between two and five kilograms has been prequalified. This formulation of artemether-lumefantrine meets global standards for quality, safety, and efficacy, marking a critical step toward safer treatment for one of the most vulnerable groups.
Until now, infants with malaria were treated using drugs formulated for older children, raising risks of dosing errors and toxicity. The new infant-specific therapy is expected to improve care for millions, especially in countries like Africa, where nearly 30 million babies are born annually in malaria-endemic regions. Prequalification also enables wider public-sector procurement, helping bridge a long-standing treatment gap.
Alongside this, WHO had also prequalified three new rapid diagnostic tests (RDTs) to tackle a growing challenge: diagnostic failure. Traditional tests detect a malaria protein called HRP2, but in many regions, especially parts of the Horn of Africa, parasite strains have evolved to evade detection by deleting the gene responsible for this protein. In some areas, up to 80% of infections were being missed.
The newly approved tests target an alternative protein, pf-LDH, offering more reliable detection and ensuring timely treatment. WHO has recommended switching to these tests in regions where HRP2-based diagnostics fail in more than 5% of cases.
Despite significant progress—2.3 billion infections prevented and 14 million lives saved since 2000—malaria remains a global threat. According to the latest global report, 2024 saw 282 million cases and 610,000 deaths, highlighting stalled progress amid rising drug resistance and funding gaps.
Still, with new tools, vaccines, and innovations, the path toward ending malaria is becoming clearer—if momentum is sustained.
REFERENCE: WHO prequalifies first-ever malaria treatment for newborns and infants, adds new diagnostic tests; WHO; https://www.who.int/news/item/24-04-2026-who-prequalifies-first-ever-malaria-treatment-for-newborns-and-infants-adds-new-diagnostic-tests
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