WHO Approves First Malaria Drug Specifically for Newborns
Kat Lay
The World Health Organization has prequalified Coartem Baby, the first malaria drug tailored for infants from 2 kg, filling a critical treatment gap. Previously, babies had to use medicines meant for older children, risking overdose and side effects. The cherry-flavored tablet dissolves in liquids and is already being used in Ghana.
The World Health Organization (WHO) has granted prequalification to Coartem Baby — the first malaria treatment specifically designed for infants weighing at least 2 kg. The move is hailed as a major public health milestone, opening access to safe treatment for the youngest patients, who were previously neglected.
Statistics show that up to 610,000 malaria deaths were recorded in 2024, with about three-quarters occurring in children under five in Africa. In some regions, as many as 18% of infants under six months are infected, yet until now there was no safe treatment regimen for this age group. The WHO notes that using drugs meant for older children raises the risk of incorrect dosing, side effects, and toxicity.
Coartem Baby comes as sweet cherry-flavored tablets that can be dissolved in liquids, including breast milk, making it easier to administer. The drug contains two antimalarial active ingredients, artemether and lumefantrine, and was developed by pharmaceutical company Novartis and the Medicines for Malaria Venture (MMV).
“For centuries, malaria has taken children from parents, health, wealth, and hope from communities,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “But today, the story has changed.”
Approval was based on recent studies that debunked the earlier misconception that infants cannot contract malaria because they inherit immunity from their mothers. In fact, young children remain at very high risk of infection.
Dr. Martin Fitchet, CEO of MMV, said: “For a long time, infants and young children with malaria have fallen through the cracks because existing treatments were not designed for them.” He called the WHO decision “a major public health milestone.”
The drug is already being deployed in Ghana. Baby Wonder, now eight months old, was one of the first patients to receive it at just 12 weeks old. He was admitted with a high fever, and tests showed high levels of malaria parasites in his blood. “I was very scared when my son got malaria because he was underweight at birth,” his mother, Naomi, said.
Dr. Emmanuel Aidoo, a pediatrician at Methodist Hospital in Ankaase, Ghana, said: “Previously, doctors would look for malaria in older children, but when infants got sick, nobody seemed to know what to do. Having a new treatment designed specifically for infants that is well tolerated gives us more confidence.”
WHO prequalification confirms the drug meets international standards for quality, safety, and efficacy, enabling high-malaria-burden countries, especially in sub-Saharan Africa, to procure it through the public sector. Novartis has pledged to supply the drug “largely on a not-for-profit basis in malaria-endemic regions.”
