WHO Grants First Prequalification for Infant Malaria Treatment
Artemether-lumefantrine becomes first antimalarial formulated specifically for newborns and infants, addressing historical dosing risks
Quick Look
- The WHO announced prequalification approval for artemether-lumefantrine, the first antimalarial formulation designed specifically for newborns and infants.
- Previously, infants were treated with formulations intended for older children, carrying greater risks of dosage errors, side effects and toxicity.
- This marks the first time the WHO has prequalified a malaria treatment for this age group.
AI-generated summary
Why It Matters
Malaria disproportionately affects young children in endemic regions, with historical treatments designed for older populations requiring off-label use for infants, increasing risks of improper dosing and toxicity.
The World Health Organization announced on Friday that it had given prequalification approval to a malaria treatment for newborns and infants for the first time. Artemether-lumefantrine is the first antimalarial formulation designed specifically for the youngest victims of the mosquito-borne disease. “The prequalification designation indicates that the medicine meets international standards of quality, safety and efficacy,” the WHO said in a statement. Up to now, infants have been treated with formulations intended for older children – carrying a greater risk of dosage errors, side effects and toxicity. “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities,” WHO chief Tedros Adhanom Ghebreyesus said. “But today, the story is changing. New vaccines, diagnostic tests, next-generation mosquito nets and effective medicines, including those adapted for the youngest, are helping to turn the tide.
Open Questions
- When will the treatment become widely available?
- What is the cost per dose?
- How many countries will adopt this formulation first?






