GENEVA – The World Health Organisation announced on April 24 that it has granted prequalification approval to an antimalarial treatment intended specifically for newborns and infants, marking the first time such a remedy has been formally certified for the youngest age group. The formulation, artemether‑lumefantrine, is designed to plug a critical gap in care for children under five, who today account for about three‑quarters of malaria deaths worldwide. The WHO stated that the prequalification means the medicine meets international standards for quality, safety and efficacy, paving the way for global procurement and distribution through public‑sector channels.
Until now, infants have largely been treated with antimalarial formulations meant for older children, raising the risk of dosing errors, side effects and toxicity. WHO Director‑General Tedros Adhanom Ghebreyesus said the new approval is part of a broader shift: “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities… but today, the story is changing.” He pointed to new vaccines, improved diagnostics, next‑generation mosquito nets and medicines tailored for the very young as reasons that ending malaria in this generation is “no longer a dream, it is a real possibility, but only with sustained political and financial commitment. Now we can. Now we must.”
In 2024, the WHO estimated 282 million malaria cases and 610,000 deaths across 80 countries, with Africa bearing 95 per cent of both burden and fatalities. The agency warns that progress is being undermined by drug and insecticide resistance, weak diagnostics and shrinking foreign‑aid budgets. By prequalifying the new infant‑adapted treatment, the WHO aims to help close a long‑standing gap for roughly 30 million babies born each year in malaria‑endemic parts of Africa. Globally, about 70 per cent of countries lack strong domestic regulatory systems, making the WHO prequalification programme a key safeguard for medicines, vaccines and medical devices used in international health programmes.