NAIROBI, Kenya — The World Health Organization (WHO) has prequalified the first malaria treatment specifically designed for newborns and young infants, marking a major breakthrough in efforts to close a long-standing treatment gap in malaria-endemic regions.
The newly approved formulation of artemether-lumefantrine is tailored for babies weighing between 2 to 5 kilograms, making it the first medicine developed specifically for the youngest and most vulnerable malaria patients.
WHO prequalification confirms the drug meets international standards of quality, safety, and efficacy, enabling its procurement for use in public health systems.
Until now, infants diagnosed with malaria have been treated using medicines designed for older children, a practice that increases the risk of dosing errors, toxicity, and adverse side effects. Health experts say the new formulation will significantly improve treatment accuracy and outcomes for newborns.
“For centuries, malaria has stolen children from their parents, and health, wealth, and hope from communities,” said Tedros Adhanom Ghebreyesus. “Ending malaria in our lifetime is no longer a dream—it is a real possibility, but only with sustained political and financial commitment.”
The development is expected to benefit an estimated 30 million babies born annually in malaria-endemic areas, particularly in Africa, where the disease continues to exact a heavy toll on children under five.
In a parallel move, WHO also prequalified three new rapid diagnostic tests (RDTs) to address emerging challenges in malaria detection. Traditional RDTs rely on detecting a parasite protein known as HRP2.
However, studies across 46 countries have found that some malaria strains have evolved to lack this protein, rendering them “invisible” to standard tests and leading to false-negative results.
The problem is especially acute in parts of the Horn of Africa, where up to 80 per cent of infections have reportedly gone undetected, delaying treatment and increasing the risk of severe illness and death.
The new RDTs target an alternative protein known as pf-LDH, which the malaria parasite cannot easily shed. WHO now recommends that countries adopt these tests where more than 5pc of cases are missed due to HRP2 gene deletions, ensuring more accurate diagnosis and timely treatment.
The announcements coincide with the launch of the 2026 World Malaria Day campaign under the theme “Driven to End Malaria: Now We Can. Now We Must,” aimed at mobilising political will and funding to eliminate the disease.
According to the World Malaria Report 2025, global progress has slowed despite notable gains. An estimated 282 million malaria cases and 610,000 deaths were recorded in 2024, marking an increase from the previous year.
Despite these setbacks, significant progress has been made over the past two decades, with approximately 2.3 billion infections prevented and 14 million lives saved since 2000. Additionally, 47 countries have been certified malaria-free, while 37 reported fewer than 1,000 cases in 2024.
Efforts to scale up prevention are also accelerating, with 25 countries rolling out malaria vaccines and next-generation mosquito nets now accounting for 84 per cent of all distributed nets globally.
