WHO Prequalifies First Malaria Treatment

Why Did Newborns and Small Infants Lack a Dedicated Malaria Treatment?

For decades, artemisinin-based combination therapies (ACTs) such as artemether-lumefantrine have been the backbone of uncomplicated malaria treatment recommended by the World Health Organization. However, clinical development of these medicines historically excluded the very smallest patients. Newborns and infants weighing less than 5 kilograms have immature liver enzyme systems, different drug clearance profiles, and pharmacokinetic patterns that cannot simply be extrapolated from older children. As a result, no ACT had ever been formally approved with dosing instructions specifically tailored for this age group.

In practice, this gap forced clinicians in malaria-endemic regions to either delay treatment, split adult or pediatric tablets, or use suboptimal regimens. Both under-dosing and over-dosing carry real risks: insufficient drug exposure can drive resistance and treatment failure, while excessive exposure can cause toxicity in a population with limited metabolic reserve. The newly prequalified product, developed through a collaboration between Novartis and the Medicines for Malaria Venture, was studied in the CALINA trial to establish appropriate dosing in this fragile population.

What Does WHO Prequalification Mean for Global Access?

The WHO Prequalification Programme acts as a global quality gatekeeper for medicines used in countries that may lack the regulatory capacity of agencies such as the FDA or EMA. When a product receives prequalification status, it becomes eligible for procurement by UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and other major buyers that channel medicines into national malaria programs. This is often the decisive step that translates a clinical advance into real-world access for patients.

Alongside the infant treatment, WHO also announced the addition of new malaria diagnostic tests to its prequalification list, reinforcing a test-and-treat approach. According to WHO data, malaria continues to cause hundreds of thousands of deaths each year, with the heaviest burden falling on children under five in sub-Saharan Africa. Closing the dosing gap for the youngest infants is expected to be especially impactful in high-transmission regions where congenital and neonatal malaria cases, while less common than in older children, carry a particularly high case-fatality rate.

How Does This Fit Into the Broader Malaria Control Strategy?

Malaria control has entered a new era thanks to the deployment of the RTS,S/AS01 and R21/Matrix-M vaccines in several African countries, alongside long-standing tools such as insecticide-treated bed nets, indoor residual spraying, and seasonal malaria chemoprevention for children in the Sahel. Yet vaccines do not eliminate the need for effective curative treatment, and growing concerns about partial artemisinin resistance in parts of East Africa make stewardship of ACTs increasingly important.

A pediatric-appropriate formulation reduces the risk of dosing errors that could otherwise accelerate resistance, while ensuring that the most vulnerable patients are not left behind by therapeutic innovation. Public health experts emphasize that no single tool will end malaria; sustained reductions depend on layering vaccines, prevention, prompt diagnosis, and age-appropriate treatment across the full pediatric age range.