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You are here: Home / cat / WHO Prequalifies First-Ever Malaria Drug for Infants

WHO Prequalifies First-Ever Malaria Drug for Infants

Dated: April 27, 2026

Ahead of World Malaria Day on 25 April, the World Health Organization (WHO) has announced a major breakthrough in malaria control with the prequalification of the first-ever treatment specifically designed for newborns and young infants weighing between two and five kilograms. The medicine, artemether-lumefantrine, meets international standards for quality, safety, and efficacy and is expected to significantly improve access to appropriate treatment for one of the most vulnerable and underserved patient groups in malaria-endemic regions.

Until now, infants with malaria have been treated using formulations intended for older children, which increased the risk of incorrect dosing, side effects, and toxicity. The newly approved infant-specific treatment will help close a critical healthcare gap affecting an estimated 30 million babies born each year in malaria-affected areas of Africa. WHO has stated that this development will enable public sector procurement and strengthen access to safer, more effective treatment options for young children.

WHO Director-General Dr Tedros Adhanom Ghebreyesus described the development as a turning point in the global fight against malaria, noting that advances in vaccines, diagnostics, mosquito nets, and medicines tailored for infants are helping to shift the trajectory of the disease. He emphasized that eliminating malaria is now an achievable goal, but only with sustained political and financial commitment from the global community.

In addition to the infant treatment, WHO has also prequalified three new rapid diagnostic tests aimed at addressing growing challenges in malaria detection. Traditional tests that target the HRP2 protein are becoming less effective in some regions due to parasite mutations that remove the gene responsible for this protein, leading to false-negative results. In parts of the Horn of Africa, this has resulted in up to 80 per cent of cases being missed, delaying treatment and increasing the risk of severe illness and death.

The new diagnostic tests instead target the pf-LDH protein, which is less likely to be affected by genetic changes in the parasite. These tests offer a more reliable alternative in areas where HRP2-based diagnostics are failing. WHO now recommends switching to these updated tests in regions where more than 5 per cent of cases are missed due to genetic deletions, ensuring more accurate diagnosis and timely treatment.

These developments come as WHO and partners launch the 2026 World Malaria Day campaign under the theme “Driven to End Malaria: Now We Can. Now We Must.” The campaign highlights both the urgency and the opportunity to accelerate progress against malaria, which continues to cause a significant global health burden.

According to the World Malaria Report 2025, there were an estimated 282 million cases and 610,000 deaths in 2024, reflecting a rise compared to the previous year. While notable progress has been made, including 47 countries being certified malaria-free and 37 countries reporting fewer than 1,000 cases, global progress is now stalling due to challenges such as drug and insecticide resistance, diagnostic limitations, and declining international funding.

Despite these setbacks, long-term progress remains significant, with an estimated 2.3 billion infections prevented and 14 million lives saved since 2000. Advances such as malaria vaccines now being deployed in 25 countries and next-generation mosquito nets making up the majority of new distributions demonstrate continued innovation in prevention and control.

WHO continues to position these advancements as proof that eliminating malaria is achievable through coordinated global action, scientific innovation, and sustained investment in health systems, particularly for the most vulnerable populations.

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