The World Health Organization (WHO) has announced a significant milestone in global health, granting prequalification approval to a malaria treatment specifically developed for newborns and infants for the first time.
The treatment, artemether-lumefantrine, is the first formulation tailored to meet the needs of the youngest patients, who are among the most vulnerable to 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.
Until now, infants have typically been treated with malaria drugs intended for older children, a practice that carries increased risks of incorrect dosing, side effects, and potential toxicity.
Highlighting the broader significance of the development, WHO Director-General Tedros Adhanom Ghebreyesus said the fight against malaria is entering a new phase.
“For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities,” he 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.
“Ending malaria in our lifetime is no longer a dream — it is a real possibility, but only with sustained political and financial commitment. Now we can. Now we must.”
According to the WHO, malaria remains a major global health challenge. In 2024 alone, there were an estimated 282 million cases and 610,000 deaths reported across 80 countries.
Africa continues to bear the greatest burden, accounting for about 95 percent of both cases and fatalities, with children under five making up nearly three-quarters of the deaths.
The agency noted that progress in combating malaria is being slowed by several factors, including drug and insecticide resistance, diagnostic challenges, and declining levels of international funding.
The WHO explained that its prequalification approval will allow the medicine to be procured by public health systems, helping to address a long-standing treatment gap affecting an estimated 30 million babies born each year in malaria-endemic regions of Africa.
