The World Health Organisation (WHO) has announced a major breakthrough in the fight against malaria, confirming on Friday that it has granted prequalification approval to a malaria treatment formulated specifically for newborns and infants for the first time.
The treatment, Artemether-lumefantrine, is the first antimalarial medicine developed with dosage and safety considerations tailored to the youngest and most vulnerable patients affected by the mosquito-borne disease.
According to the WHO, the prequalification status means the drug has met global standards for quality, safety, and effectiveness, allowing it to be considered for large-scale procurement by governments and international health agencies.
Until now, infants in malaria-endemic regions have largely been treated with medications originally designed for older children, a practice that often increased the risk of incorrect dosing and potential side effects.
WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, described the development as a significant turning point in the global response to malaria.
“For centuries, malaria has stolen children from their parents and robbed communities of health, wealth, and hope,” he said. “But today, the story is changing. New vaccines, improved diagnostics, better mosquito nets, and now medicines adapted for infants are helping to turn the tide.”
He added that while ending malaria remains a major global challenge, it is no longer an impossible goal, stressing the need for continued political and financial commitment.
The WHO estimates that in 2024 alone, there were about 282 million malaria cases and 610,000 deaths across 80 countries. Africa bears the heaviest burden, accounting for roughly 95 percent of cases and deaths, with children under five making up about three-quarters of fatalities.
Health experts say progress against the disease is being slowed by growing resistance to drugs and insecticides, diagnostic challenges, and declining international funding support.
The WHO noted that its prequalification of the new infant-specific treatment could help bridge a long-standing gap in care for an estimated 30 million babies born each year in malaria-affected regions of Africa.
Globally, the agency also warned that many countries still lack strong regulatory systems to properly evaluate medicines and health products, making its prequalification programme a critical tool for ensuring safety and reliability in global health procurement.
