The World Health Organization has approved the first antimalarial specifically formulated for infants, announcing the decision just ahead of World Malaria Day on April 25. The new combination of artemether and lumefantrine is the first medicine shown to be safe for babies weighing under 5 kilograms (2.2 pounds).
Until now, newborns and very young infants were given formulations designed for older children, increasing the risk of dosing mistakes and toxicity. WHO’s approval is a prequalification, which helps countries that lack capacity to run full clinical trials authorize the product and allows UN agencies to procure and distribute it in malaria-endemic areas, subject to national approval.
Young children remain the most affected: about 70% of malaria deaths occur in children under five. Malaria during pregnancy also has a heavy toll, contributing annually to an estimated 10,000 maternal deaths, 200,000 stillbirths and roughly 550,000 low-birth-weight newborns, according to WHO. Global efforts since 2000 have averted an estimated 14 million deaths, but the disease persists — in 2024 there were about 282 million cases and more than half a million deaths.
Sub-Saharan Africa carries the largest share, with nine out of ten cases and deaths. The infant-specific formulation fills a gap affecting roughly 30 million babies born each year in malaria-endemic parts of the continent. WHO Director-General Tedros Adhanom Ghebreyesus said malaria has long robbed children, families and communities of health and hope, and that recent advances — including new vaccines, diagnostics, mosquito nets and medicines — are helping to turn the tide.
Earlier in April, WHO also approved three new rapid diagnostic tests after parasites evolved to evade detection in some areas, causing false negatives that missed up to 80% of cases in parts of the Horn of Africa. In 2021 WHO recommended the first malaria vaccine, which has since been rolled out at scale in multiple African countries to protect young children.