WHO Pre‑Qualifies First Infant Malaria Drug, Enabling 5,000+ Treatments in Ghana

Context Malaria kills an estimated 610,000 people each year, three quarters of them children under five. Infants weighing less than 4.5 kg have previously been treated with adult or older‑child formulations, increasing the risk of dosing errors and toxicity. The World Health Organization’s pre‑qualification process validates that a product meets international standards for quality, safety and efficacy, allowing agencies such as the Global Fund to purchase it in bulk.

Key Facts - Coartem® Baby, an artemether‑lumefantrine combination, received WHO pre‑qualification, marking the first time a malaria treatment is approved for newborns and infants as light as 2 kg. - Since its launch in Ghana, more than 5,000 treatment courses have been ordered, exceeding early expectations. - WHO Director‑General Dr Tedros noted that the new formulation closes a treatment gap for roughly 30 million babies born annually in malaria‑endemic African regions. - The drug was approved by Swissmedic in July 2025 and is being rolled out through public and private procurement channels. Eight additional African nations have joined the Swissmedic “Marketing Authorisation for Global Health Products” process to fast‑track national approvals.

What It Means The pre‑qualification removes a major barrier to large‑scale procurement, allowing the Global Fund and UNICEF to include Coartem® Baby in future purchase plans. With WHO treatment guidelines slated for update in mid‑2026, the drug could become a standard of care across malaria‑endemic countries, reducing reliance on off‑label dosing for the smallest patients. For parents in Ghana, the availability of a dose‑accurate, infant‑specific therapy means fewer medication errors and a lower risk of severe side effects.

Looking Ahead Watch for the inclusion of Coartem® Baby in WHO’s 2026 treatment guidelines and subsequent procurement announcements from the Global Fund, which will signal the scale of rollout across the continent.