For the first time in history, newborn babies with malaria have a treatment made specifically for them. The World Health Organization has granted prequalification to Coartem Baby, a cherry-flavored dissolvable tablet that can safely treat infants as small as 2 kilograms — a milestone that could save tens of thousands of young lives each year.
At a glance
- Coartem Baby: The new drug combines two antimalarial compounds, artemether and lumefantrine, in a sweet tablet that dissolves in liquid, including breast milk, making it practical for caregivers of the smallest infants.
- WHO prequalification: This approval signals that the drug meets international standards for quality, safety, and efficacy — and unlocks public-sector procurement for high-burden countries, particularly across sub-Saharan Africa.
- Malaria mortality: There were 610,000 deaths from malaria in 2024 C.E., with about three-quarters occurring in children under five in Africa — many of them infants who had no safe treatment option.
Why newborns were left out
The gap in care has deep roots in a persistent medical misconception. For decades, many clinicians assumed newborns were protected from malaria by immunity passed from their mothers during pregnancy and breastfeeding. Research over the past 20 years has steadily dismantled that assumption.
In parts of Africa, up to 18% of children under six months old become infected with malaria. Yet the only available treatments were formulations designed for older children or adults — and using them on infants meant guesswork on dosing, with real risks of side effects and toxicity.
“For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind,” said Dr. Martin Fitchet, chief executive of the Medicines for Malaria Venture (MMV), the nonprofit product development partnership that co-developed the drug alongside the pharmaceutical company Novartis.
A treatment built from scratch for the smallest patients
Coartem Baby is not a scaled-down adult drug. It was designed specifically for infants, with a formulation that accounts for how very young bodies absorb and process medication. The tablet dissolves easily into breast milk or water, which matters enormously in settings where caregivers may have little equipment and where building trust in new medicines depends on ease of use.
Novartis has committed to making the treatment available on a largely not-for-profit basis in malaria-endemic regions — a pricing decision that could determine whether the drug reaches the communities that need it most or stalls in procurement pipelines.
The drug was developed through a partnership between Novartis and Medicines for Malaria Venture, a Geneva-based organization that funds and coordinates research into treatments for the world’s poorest patients. That model — public-private collaboration anchored by a nonprofit mandate — has become one of the more promising structures for driving innovation in neglected disease areas.
Ghana leads the way
The treatment has already been introduced in Ghana, where one early patient offers a glimpse of what the drug can mean in practice. Baby Wonder, now eight months old in 2026 C.E., received Coartem Baby at 12 weeks old after presenting at a hospital with a high fever and elevated malaria parasites in his blood.
“I was very scared when my son got malaria because he was born underweight,” said his mother, Naomi. Today, Wonder is healthy.
Dr. Emmanuel Aidoo, a paediatrician at Methodist Hospital in Ankaase, Ghana, described the shift in clinical confidence. “As doctors we have tended to look for malaria in older children, but when newborn babies got sick nobody seemed to know what to do,” he said. “Having a new treatment tailor-made for infants that is well tolerated gives us confidence.”
Ghana’s early rollout provides a real-world proof of concept — and a model for how other high-burden countries might move quickly once procurement is in place. The WHO Global Malaria Programme has been working with national health ministries across sub-Saharan Africa to accelerate access to new tools.
Part of a broader turning point
The Coartem Baby approval arrives at a moment of cautious momentum against malaria. The R21/Matrix-M malaria vaccine, developed by the University of Oxford and the Serum Institute of India, has begun rolling out in several African countries, offering protection to children from around five months of age. Next-generation insecticide-treated bed nets have shown strong results in reducing transmission. Rapid diagnostic tests have become more widely available at the community level.
“For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities,” said Dr. Tedros Adhanom Ghebreyesus, the WHO director general. “But today, the story is changing.”
That change is not yet complete. The WHO World Malaria Report 2024 noted that progress has stalled in several regions, partly due to funding shortfalls and supply chain disruptions. Getting Coartem Baby from regulatory approval to a clinic shelf in rural sub-Saharan Africa will require sustained investment and political will — neither of which can be assumed. The drug’s not-for-profit pricing commitment is a start, but procurement at scale remains an open question.
Still, the fact that the smallest, most vulnerable patients now have a tool designed specifically for them marks a real shift in what medicine thinks is possible — and who it believes is worth designing for.
Read more
For more on this story, see: The Guardian
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- The Good News for Humankind archive on global health
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