The World Health Organisation (WHO) has granted prequalification approval to a malaria treatment for newborns and infants for the first time, the agency announced on Friday.
The medicine, Artemether-lumefantrine, is the first antimalarial formulation developed 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.
Previously, infants were treated with formulations intended for older children, which carried a greater risk of dosage errors, side effects and toxicity.
A turning point in the fight against malaria
WHO Director-General Tedros Adhanom Ghebreyesus described the approval as a historic shift.
“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.”
Africa bears the heaviest burden
According to WHO estimates for 2024, there were 282 million malaria cases and 610,000 deaths across 80 countries. Africa accounts for 95 per cent of cases and deaths, with children under five representing three-quarters of those fatalities.
The UN health agency has warned that progress against malaria is being hampered by drug resistance, insecticide resistance, diagnostic failure, and sharp reductions in foreign aid spending.
Closing a long-standing treatment gap
The WHO said its prequalification would enable public sector procurement and help close a long-standing treatment gap for the roughly 30 million babies born each year in malaria-endemic regions of Africa.
Globally, 70 per cent of countries lack regulatory systems robust enough to oversee medicines, vaccines, tests and medical devices. The WHO prequalification programme ensures that key health products for international procurement meet global standards of quality, safety, efficacy and performance.
