The World Health Organization (WHO) has approved the first-ever malaria treatment specifically designed for newborns and infants, marking a major breakthrough in the fight against the disease.
The treatment, artemether-lumefantrine, received prequalification status on Friday, confirming it meets global standards for quality, safety and effectiveness.
Until now, babies have been treated using medicines developed for older children, a practice that increased the risk of dosing errors, harmful side effects and toxicity.
According to WHO Director-General Tedros Adhanom Ghebreyesus, the development signals a turning point in global malaria control.
“For centuries, malaria has stolen children from their parents and drained communities of health and prosperity,” he said.
He added that advances such as vaccines, improved diagnostic tools, next-generation mosquito nets and targeted medicines are helping to reduce the burden of the disease.
WHO data shows that in 2024, malaria caused an estimated 282 million infections and 610,000 deaths across 80 countries. Africa remains the hardest-hit region, accounting for 95 per cent of cases and deaths.
Children under five are the most vulnerable, representing nearly three-quarters of malaria-related deaths globally.
The agency warned that progress is being slowed by drug and insecticide resistance, weak diagnostic systems and declining international funding.
The new prequalified treatment is expected to improve access to safe medicines for about 30 million babies born each year in malaria-endemic regions, particularly in Africa.
WHO noted that its prequalification programme helps countries with weaker regulatory systems to procure safe and effective medical products.
Health experts say the approval could help close a long-standing treatment gap and significantly reduce infant mortality linked to malaria.
