When a baby in a malaria-endemic region of Africa falls ill weighing only two or three kilograms, doctors and mothers have until now reached for medicines designed for children of at least five kilograms. Doses were estimated, divided or improvised. On 24 April 2026, the World Health Organization brought that practice to an end: with the WHO prequalification of Coartem Baby, a combination of artemether and lumefantrine, there is now for the first time an antimalarial drug developed specifically for newborns and infants weighing between two and five kilograms.
A Gap That Has Existed for Decades
Malaria is one of the leading causes of death in children under five in Africa. According to the WHO World Malaria Report 2024, there were 263 million malaria cases and 597,000 deaths worldwide in 2023, of which around 76 percent were children under five in sub-Saharan Africa. Many of these deaths are infants in their first six months of life.
The problem is not just the parasite. It is also that the pharmacology of newborns differs fundamentally from that of older children. A newborn's metabolism processes drugs differently; what works for a two-year-old can be underdosed or toxic in a three-kilogram infant. Coartem, the most widely used antimalarial worldwide and also made by Novartis, is approved from five kilograms upward. Below that, there was nothing.
Novartis developed Coartem Baby in partnership with the Medicines for Malaria Venture (MMV), a non-profit organisation that pools public and private funding. Clinical development was financed in part by the EU's EDCTP2 program and Swedish development aid SIDA through the PAMAfrica consortium. In the CALINA clinical trial, the correct pharmacology for this age group was established: appropriate drug distribution in the body, effective parasite reduction and good tolerability.
What WHO Prequalification Means
WHO prequalification is not a quality seal in the ordinary sense. It is a purchasing signal for the global health market. Organisations such as UNICEF, the Global Fund and national health ministries buy only prequalified medicines. Without this status, a drug remains effectively invisible for public health procurement in low-income countries, regardless of its efficacy.
At the same time as Coartem Baby, the WHO prequalified three new rapid diagnostic tests for malaria that address a growing diagnostic problem. In parts of East Africa, particularly around the Horn of Africa, parasite strains have emerged that have deleted the HRP2 gene. Conventional rapid tests rely on this protein and produce false negatives in these cases, showing no reaction despite active infection. According to the WHO, this affects up to 80 percent of cases in some regions. The new tests bypass this blind spot.
Where Similar Progress Has Been Made
Coartem Baby stands in a line of pharmacological gap-closers that have reached clinical maturity in recent years. Bepirovirsen, a hepatitis B drug, is close to FDA approval and could enable functional cure for the first time, after hepatitis B has been treatable but not curable since the 1980s. The Moderna-Merck mRNA cancer vaccine program for melanoma delivered five-year data in 2024 showing halved recurrence rates.
What distinguishes Coartem Baby is its target population. While many medical breakthroughs reach wealthy countries first, the 30 million infants born annually in malaria-endemic areas are a group that has historically offered little market incentive to the global pharmaceutical sector. Development was only possible because MMV as a non-profit intermediary absorbed risks that no single company was willing to take alone.
National Approval: The Next Step
WHO prequalification opens the path to procurement but does not replace national regulatory approval. Countries such as Nigeria, the Democratic Republic of Congo, Uganda and Mozambique, together responsible for the vast majority of global malaria cases, must incorporate Coartem Baby into their national formularies. MMV and the WHO intend to actively support this process. How quickly it proceeds depends on the capacity of national agencies and on funding from the Global Fund and bilateral donors.
Malaria today kills half as many people as it did 25 years ago, despite global population growth. That is the result of bed nets, rapid diagnostic tests, artemisinin combination therapies and, most recently, the RTS,S childhood vaccine. Coartem Baby closes a concrete gap in this system, for the patients who were previously the most exposed.