WHO prequalifies first‑ever malaria treatment for newborns and young infants

The World Health Organization (WHO) has prequalified a malaria treatment designed specifically for newborns and young infants for the first time. This is a breakthrough that could reshape an the fight against one of the world’s deadliest diseases, particularly across Africa, where malaria’s toll is greatest.

Announced on the eve of World Malaria Day, WHO granted prequalification to an infant-specific formulation of artemether–lumefantrine, designed for babies weighing as little as two kilograms and up to five kilograms. The designation signals that the treatment meets international standards for safety, quality and efficacy, paving the way for large‑scale procurement by governments and global health agencies.

For decades, clinicians have been forced to treat infants with medicines formulated for older children – an imprecise workaround that carried real risks: Overdosing, toxic side effects and, in the most fragile patients, death. The new formulation helps close that gap with precision dosing designed for the very young bodies.

Reprieve for Africa

The WHO African Region accounts for an estimated 94% of malaria cases and 95% of malaria deaths worldwide. In 2024 alone, malaria infected an estimated 282 million people worldwide and killed 610,000. Children under five, most of them in sub‑Saharan Africa, account for roughly three quarters of all malaria deaths in the African Region. For millions of families, malaria is not an abstract public health concern but a recurring, often fatal, reality that begins in the earliest months of life.

Each year, around 30 million babies are born in malaria-endemic regions of Africa. Until now, many entered a world where the available tools to treat them safely were either adapted from older age groups or lacked the precision needed for this youngest cohort. With prequalification, WHO expects the new infant therapy to be incorporated into public health systems, expanding access to reliable treatment at community level, where many malaria deaths occur.

"Ending malaria in our lifetime is no longer a dream—it is a real possibility, but only with sustained political and financial commitment,” said WHO Director-General Tedros Adhanom Ghebreyesus, noting that malaria has long drained both lives and economic potential from entire regions.

Next-generation diagnostics

The approval comes alongside another advance: WHO prequalified three new rapid diagnostic tests on April 14, 2026 designed to address diagnostic challenges caused by malaria parasite strains that can become harder to detect with older tests. 

Many commonly used RDTs for Plasmodium falciparum rely on detecting a protein called HRP2. However, in parts of the Horn of Africa, certain parasite strains carry deletions of the gene associated with HRP2, up to 80% of cases were missed, leading to delayed treatment, severe illness and even death.

The newly prequalified tests target a different parasite protein (pf-LDH), offering a quality-assured alternative where HRP2-based RDTs fail. WHO recommends switching away from exclusive HRP2-based testing where more than 5% of cases are missed due to pfhrp2 deletions.

Together, these moves signal a shift in malaria control—from broad, one-size-fits-all tools toward more targeted, next-generation interventions. Vaccines are being rolled out in 25 countries. More effective mosquito nets now dominate distribution campaigns. Since 2000, an estimated 2.3 billion infections have been prevented and 14 million lives saved.

Fragile progress

Drug resistance is spreading and mosquitoes are adapting to insecticides. Funding from international donors, long the backbone of malaria control in Africa, is tightening. According to the 2025 World Malaria Report, global malaria investments in 2024 reached only $3.9 billion, less than half the $9.3 billion target set by WHO. In many countries, regulatory systems remain too weak to independently guarantee the safety and quality of medicines, making WHO’s prequalification remains a key safeguard.

Against that backdrop, the new infant treatment is both a breakthrough and a test: Proof that innovation is possible, but also a reminder that sustained political will and financing are essential to ensure real-world access especially across Africa, where the burden is heaviest.

The science is advancing. The question, increasingly, is whether the world will keep pace.