The World Health Organization (WHO) on Friday announced that it has granted prequalification approval to a malaria treatment specifically designed for newborns and infants, marking a first in global healthcare.
The medicine, artemether-lumefantrine, is the first antimalarial formulation developed exclusively for very young children affected by the mosquito-borne disease.
In a statement, the WHO said that prequalification confirms the drug meets international standards for quality, safety and effectiveness.
Until now, infants were treated using medicines meant for older children, which increased the risk of incorrect dosage, side effects and potential toxicity.
WHO Director-General Tedros Adhanom Ghebreyesus said malaria has long caused significant loss of life and hardship, particularly among children. He added that recent advances, including vaccines, improved diagnostics, advanced mosquito nets and age-appropriate medicines, are helping improve outcomes.
He noted that eliminating malaria is now achievable, provided there is continued political support and adequate funding.
According to WHO estimates, there were around 282 million malaria cases and 610,000 deaths reported across 80 countries in 2024. Africa accounted for about 95 per cent of these cases and deaths, with children under five making up nearly three-quarters of the fatalities.
The WHO also highlighted challenges such as drug resistance, resistance to insecticides, diagnostic limitations and declining international funding, which continue to affect malaria control efforts.
The prequalification is expected to support public sector procurement and help address a major treatment gap, particularly for nearly 30 million babies born annually in malaria-affected regions of Africa.
Globally, about 70 per cent of countries lack strong regulatory systems to effectively monitor medicines, vaccines and medical devices. The WHO prequalification programme helps ensure that essential health products meet global standards before being supplied internationally.
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