WHO Approves First Malaria Treatment for Newborns and Infants

The World Health Organization granted prequalification approval on Friday to artemether-lumefantrine, the first antimalarial treatment specifically formulated for newborns and infants, marking a major milestone in pediatric infectious disease care. The approval will enable public sector procurement and help close a treatment gap for approximately 30 million babies born annually in malaria-endemic areas of Africa, where children under five account for three-quarters of the 610,000 malaria deaths recorded in 2024. Previously, infants were treated with formulations designed for older children, carrying greater risks of dosage errors and toxicity. The development comes as malaria progress faces challenges from drug resistance, insecticide resistance, and sharp reductions in foreign aid spending across the 80 countries reporting an estimated 282 million cases in 2024.

WHO Approval of New Infant Malaria Treatment

• ▪The WHO prequalification of artemether-lumefantrine will enable public sector procurement and help close a treatment gap for around 30 million babies born each year in malaria-endemic areas of Africa
• ▪The World Health Organization gave prequalification approval to a malaria treatment for newborns and infants on Friday
• ▪Artemether-lumefantrine is the first antimalarial formulation designed specifically for newborns and infants
• ▪The WHO prequalification designation for artemether-lumefantrine indicates that the medicine meets international standards of quality, safety and efficacy
• ▪Infants have previously been treated with malaria formulations intended for older children, carrying a greater risk of dosage errors, side effects and toxicity

Global Malaria Burden and Impact on Children

• ▪There were an estimated 610,000 malaria deaths in 2024 across 80 countries
• ▪Around 30 million babies are born each year in malaria-endemic areas of Africa
• ▪Africa accounts for 95% of malaria cases and deaths globally
• ▪There were an estimated 282 million malaria cases in 2024 across 80 countries
• ▪Children under five account for three-quarters of malaria deaths in Africa

Challenges in Malaria Control and Treatment Access

• ▪Globally, 70% of countries do not have regulatory systems robust enough to oversee medicines, vaccines, tests and medical devices
• ▪Progress against malaria is being hampered by drug resistance, insecticide resistance, diagnostic failure and sharp reductions in foreign aid spending
• ▪The WHO prequalification program ensures that key health products for international procurement meet global standards of quality, safety, efficacy and performance

Perspective of World Health Organization

• ▪The WHO prequalification of artemether-lumefantrine for newborns and infants represents a significant milestone in pediatric infectious disease care
• ▪The WHO prequalification program helps address the problem that 70% of countries globally lack robust regulatory systems for medicines and medical devices

Perspective of Public health officials in malaria-endemic African countries

• ▪Public sector procurement of artemether-lumefantrine for infants can now proceed following WHO prequalification approval
• ▪The artemether-lumefantrine prequalification will reduce dosage errors and toxicity risks that occurred when infants were treated with formulations designed for older children

Perspective of Global health advocates

• ▪Drug resistance and insecticide resistance are undermining global efforts to combat malaria despite new treatments like artemether-lumefantrine
• ▪The artemether-lumefantrine approval comes at a critical time when sharp reductions in foreign aid spending are hampering malaria progress