World Health Organization Prequalifies First Specialized Malaria Treatment for Newborns and Vulnerable Young Infants

WHO grants prequalification to Coartem Baby, the first malaria treatment for infants 2-5kg, alongside new tests to detect "invisible" parasite strains.

By: AXL Media

Published: Apr 25, 2026, 4:30 AM EDT

Source: Information for this report was sourced from The World Health Organization

Closing the Therapeutic Gap for the Youngest Patients

In a significant advancement for pediatric medicine, the World Health Organization (WHO) has granted prequalification status to a new formulation of artemether-lumefantrine designed for infants weighing as little as two kilograms. Historically, clinicians have been forced to adapt adult or older-child formulations for newborns, a practice that carries high risks of toxicity and inaccurate dosing. This newly specialized treatment, developed through a partnership between Novartis and the Medicines for Malaria Venture, ensures that the most vulnerable patients receive life-saving medication tailored to their specific physiological needs. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized that adapting medicines for the youngest patients is essential to making the goal of ending malaria a reality.

Combating Invisible Parasites With Next-Generation Diagnostics

Parallel to the treatment breakthrough, the WHO has prequalified three new rapid diagnostic tests (RDTs) to address a growing biological threat. Traditional tests rely on detecting the HRP2 protein, but recent surveys across 46 countries have revealed that some malaria strains have deleted the gene responsible for this protein, rendering them "invisible" to standard diagnostics. In parts of the Horn of Africa, these deletions have caused up to 80% of cases to be missed, leading to dangerous delays in care. The new tests target the pf-LDH protein, a more stable marker that the parasite cannot easily shed, providing a reliable alternative for regions where HRP2-based tests are failing.

Stalling Progress Amid Rising Global Infection Rates

The 2025 World Malaria Report paints a sobering picture of the current global situation, revealing an estimated 282 million cases and 610,000 deaths in 2024. This represents an increase of approximately 9 million cases compared to the previous year, suggesting that global progress is beginning to stall. While 47 countries have been certified malaria-free, the WHO African Region continues to bear the heaviest burden, accounting for 94% of all cases and 95% of deaths. High-risk factors such as drug resistance, insecticide resistance, and significant reductions in international development assistance are cited as primary obstacles to maintaining the control gains achieved over the last two decades.