Ahead of World Malaria Day on April 25, the World Health Organization (WHO) on Friday approved the first malaria drug specifically formulated for infants. The new combination of artemether and lumefantrine is the first antimalarial shown to be safe for babies weighing less than 5 kilograms (2.2 pounds).
Until now, newborns and very young infants were treated with formulations developed for older children, increasing the risk of dosing errors and toxicity. WHO’s approval — a prequalification that lets countries authorize the drug even if they lack capacity to run full clinical trials — also allows UN agencies to procure and distribute the treatment in malaria-endemic areas, subject to government approval.
Children under five remain the most vulnerable, accounting for about 70% of malaria deaths. Malaria also has a major impact during pregnancy, contributing each year to an estimated 10,000 maternal deaths, 200,000 stillbirths and roughly 550,000 low-birth-weight newborns, according to WHO. Since 2000, global efforts have averted an estimated 14 million deaths, but malaria remains a major challenge, with around 282 million cases and more than half a million deaths reported in 2024.
Sub-Saharan Africa bears the brunt of the burden, accounting for nine out of 10 cases and deaths. The infant-specific formulation closes a care gap affecting some 30 million babies born annually in malaria-endemic parts of the continent. “For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities,” WHO chief Tedros Adhanom Ghebreyesus said, adding that new vaccines, diagnostics, mosquito nets and medicines are helping to turn the tide.
In early April, WHO also approved three new rapid diagnostic tests after parasites evolved to evade detection, with some areas in the Horn of Africa missing up to 80% of cases due to false negatives. In 2021, WHO recommended the first malaria vaccine, which has since been rolled out at scale to protect young children in multiple African countries.