WHO Approves First Malaria Treatment for Newborns and Infants

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WHO Prequalifies First Malaria Treatment for Newborns and Infants In a landmark announcement ahead of World Malaria Day 2026, the World Health Organization (WHO) has prequalified the first malaria treatment specifically designed for newborns and young infants. This milestone addresses a long-standing gap in malaria care for the most vulnerable patients. The newly approved treatment, artemether-lumefantrine formulated for infants weighing between two and five kilograms, is the first antimalarial medicine developed exclusively for this age group. Until now, infants with malaria have been treated using formulations intended for older children, increasing the risk of dosing errors, side effects, and toxicity. WHO prequalification signifies that the medicine meets international standards for quality, safety, and efficacy. This designation enables public sector procurement by United Nations agencies and other procurement bodies, facilitating broader access in malaria-endemic regions. According to WHO, approximately 30 million babies are born each year in malaria-endemic areas of Africa, underscoring the critical need for age-appropriate treatment solutions. The organization emphasizes that this advancement represents a significant step toward reducing malaria-related mortality among infants. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, highlighted the broader context of progress in malaria control, noting that recent vaccines, diagnostic tools, next-generation mosquito nets, and effective medicines are collectively helping to turn the tide against the disease. He stressed that ending malaria in our lifetime remains achievable with sustained political and financial commitment. The treatment, known as Coartem® Baby (or Riamet® Baby in some countries), was developed in collaboration with Medicines for Malaria Venture (MMV). Novartis announced that it will make the treatment available on a largely not-for-profit basis in regions where malaria is endemic. In addition to the treatment prequalification, WHO announced on April 14, 2026, the prequalification of three new rapid diagnostic tests (RDTs) designed to address emerging diagnostic challenges for malaria. These tests detect the HRP2 protein associated with Plasmodium falciparum, the most common and deadly malaria parasite. This coordinated approach—combining age-appropriate treatment with improved diagnostics—aims to strengthen malaria control efforts and protect the youngest and most vulnerable populations.

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