In parts of Africa up to 18% of infants younger than six months are infected with malaria. The World Health Organization has approved the first antimalarial medicine formulated for babies, following some 610,000 malaria deaths in 2024. Branded Coartem Baby, it treats infants from 2kg and comes as cherry-flavoured tablets that can be dissolved into liquids. WHO prequalification will allow governments and donors to purchase the treatment for public programmes and closes a long-standing gap in care for newborns and young infants.

The WHO ruling removes a major barrier to treating the youngest patients with malaria.

The agency judged the new formulation to meet international standards of quality, safety and efficacy. That status, known as prequalification, lets public health authorities and global buyers include the medicine in procurement plans.

Why a baby formulation matters

Until now infants with malaria were treated with medicines meant for older children. Those products often led to dosing mistakes, more side effects and higher risks of toxicity, the WHO said. Young infants have different needs. Their bodies process drugs differently. Small errors can have bigger consequences.

Coartem Baby contains two established antimalarial compounds, artemether and lumefantrine. The combination has been used in older children and adults. What's new is the dose size, the way the tablets are flavoured, and the option to dissolve them into liquids. That makes it easier to give the correct dose to babies as small as 2kg.

In parts of Africa as many as 18% of children younger than six months are infected with malaria, the WHO said. The disease still kills large numbers of young children. In 2024 roughly three quarters of the 610,000 malaria deaths occurred in children under five in Africa.

Voices from health leaders and clinicians

Dr Tedros Adhanom Ghebreyesus, WHO director general, framed the decision as a turning point. "For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities," he said. "But today, the story is changing."

Martin Fitchet, chief executive of the Medicines for Malaria Venture, said newborns and young infants had "fallen through the cracks" because existing products were not designed for them. He called the WHO ruling "a major public-health milestone."

Clinicians who have used the medicine report practical benefits. Dr Emmanuel Aidoo, a paediatrician at Methodist hospital in Ankaase, Ghana, said having a treatment made for infants that's well tolerated gives doctors more confidence when a newborn is unwell. He added that clinicians have historically focused on older children when testing for malaria, and that infants were often left without clear options.

Mastheads

The treatment is already being used in some settings. Ghana has introduced Coartem Baby into clinical care. One of the first patients to receive the medicine was Baby Wonder, who was treated at 12 weeks after presenting with fever and a raised malaria parasite count. His mother, Naomi, said she had been very worried because he had been born underweight. Health staff report that Wonder is now healthy and thriving.

Development and the science behind the move

The infant formulation was developed by the Swiss pharmaceutical firm Novartis together with the Medicines for Malaria Venture. The companies adapted the long-used artemether-lumefantrine combination to meet the needs of the smallest patients.

Research in recent years has challenged a long-held belief that very young infants are protected from malaria by antibodies passed from their mothers. Studies have shown that newborns and infants can and do become infected. That finding pushed researchers and funders to prioritise products for this age group.

The WHO approval follows that research and a programme of trials and safety checks. The cherry flavour and the dissolvable format respond to practical hurdles in clinical care. Infants often can't swallow pills. Liquid suspensions can be hard to dose accurately in resource-limited clinics. The new tablet aims to reduce those problems.

Economic and political implications

WHO prequalification is a key step for making the drug available through government and donor channels. Procurement agencies and ministries of health commonly require that status before ordering large volumes. That means national programmes in malaria-endemic countries can now plan to include the infant drug alongside existing treatments, diagnostics and prevention tools.

Governments will need to budget for the new product. That affects health ministry spending plans and donor commitments. Buying a new formulation may shift where limited funds go within national malaria programmes. It could change the mix of interventions that countries prioritise when budgets are tight.

Pharmaceutical manufacturing and supply chains will also be affected. Producing a tailored paediatric product requires dose-specific manufacturing, packaging and quality assurance. That can raise unit costs compared with mass-produced adult formulations. But if the product reduces dosing errors and hospital admissions, it could lower overall treatment costs in the long run.

There are political implications too. Donors and global health organisations have set big targets in recent years: new vaccines, better diagnostics and next-generation bednets. Dr Tedros pointed to that package of tools when he praised the approval. Adding an infant-specific drug strengthens the policy case for integrated child health programmes and gives ministers a new option when crafting national strategies.

Approval doesn't mean instant, universal access. Countries must update treatment guidelines, retrain health workers and adapt supply chains. Clinicians must learn new dosing schedules and recognise when infants should be tested and treated.

Rolling out the drug will take time. Procurement cycles, national regulatory approvals and distribution systems all add delay. But the WHO prequalification removes a major legal and logistical obstacle to buying the drug in bulk for public clinics and hospitals.

Implementation partners and ministries will weigh where to place the medicine in routine child health visits and how to combine it with other preventive measures. Where malaria burden is concentrated in very young infants, the drug may be introduced through outpatient clinics, neonatal wards and community health programmes.

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Ghana has already begun using Coartem Baby; one of the first recipients was a 12-week-old who was treated after testing positive for malaria and is now reported to be healthy.

This article was created with AI assistance.