When newborns got sick, nobody seemed to know what to do
For generations, the youngest victims of malaria — newborns too small to receive any existing treatment — existed in a medical blind spot, their suffering acknowledged but unanswered. The World Health Organization's approval of Coartem Baby, the first antimalarial formulated for infants as small as 2 kilograms, closes a gap that cost hundreds of thousands of lives annually, most of them children under five in sub-Saharan Africa. It is a moment that reminds us how much suffering can persist not from ignorance of a disease, but from the quiet assumption that the most vulnerable were somehow protected — and how much changes when that assumption is finally questioned.
- Up to 18% of African infants under six months contract malaria, yet until now physicians faced an agonizing choice between dangerous improvisation with adult formulations or doing nothing at all.
- 610,000 people died from malaria in 2024 — three-quarters of them children under five — a toll shaped in part by the absence of any treatment designed for the smallest patients.
- Coartem Baby, developed by Novartis with the Medicines for Malaria Venture, dissolves into liquids including breast milk, eliminating the dosing errors and toxicity risks that made existing drugs too dangerous for newborns.
- WHO prequalification unlocks public-sector procurement across malaria-endemic regions, with Novartis committing to largely not-for-profit access — meaning the medicine can now move from approval to the hospitals and clinics that need it most.
- In Ghana, a twelve-week-old boy named Wonder — born underweight, testing positive for malaria — became an early recipient of the treatment and is today, at eight months, thriving.
For the first time, a medicine exists that was made for newborns with malaria. The World Health Organization has approved Coartem Baby, a treatment designed for infants as small as 2 kilograms — ending a gap that left the tiniest patients without any safe option while malaria killed 610,000 people in 2024, most of them young children in Africa.
The scale of the problem had long been obscured by a mistaken assumption: that infants carried protective immunity passed from their mothers. Research eventually dismantled that belief. In parts of Africa, up to 18 percent of babies under six months contract malaria, and when they arrived at hospitals with fever and parasites in their blood, doctors had no safe recourse. Using formulations designed for older children risked dangerous dosing errors and toxicity. The alternative was nothing.
Coartem Baby, developed by Novartis and the Medicines for Malaria Venture, contains artemether and lumefantrine in cherry-flavored tablets that dissolve into liquids, including breast milk. WHO prequalification means the drug meets international standards and can now be procured by public health systems across malaria-endemic regions. Novartis has committed to making it available on a largely not-for-profit basis.
The human weight of the approval is carried by cases like Wonder, a twelve-week-old in Ghana born underweight, whose mother Naomi brought him to the hospital with a high fever. When tests confirmed malaria, doctors were able to access Coartem Baby. Wonder is now eight months old and healthy — an outcome that was, until recently, simply not possible.
For pediatricians like Dr. Emmanuel Aidoo in Ghana, the shift is felt as restored confidence: the ability to act when a newborn is sick, rather than face paralysis. WHO Director General Dr. Tedros Adhanom Ghebreyesus placed the moment in longer perspective — centuries of malaria stealing children from families — and named it, carefully, as a change in the story.
For the first time, newborns sick with malaria have a medicine made for them. The World Health Organization has approved Coartem Baby, a treatment designed specifically for infants as small as 2 kilograms—about 4.4 pounds—marking the end of a gap that has left the tiniest patients vulnerable to a disease that killed 610,000 people in 2024, three-quarters of them children under five in Africa.
The scale of the problem was always there, hidden in plain sight. In parts of Africa, up to 18 percent of babies under six months old contract malaria. Yet until now, doctors had no safe option. When a newborn arrived at the hospital burning with fever and tests showed the parasite in their blood, physicians faced an impossible choice: use medication formulated for older children and risk dosing errors, dangerous side effects, and toxicity, or have nothing at all. The assumption that infants retained immunity from their mothers—passed through pregnancy and breast milk—turned out to be wrong. Research in recent years has challenged this long-held belief, revealing that babies could and did get sick, and that they were dying without treatment.
Coartem Baby contains two antimalarial drugs, artemether and lumefantrine, and comes as sweet cherry-flavored tablets that dissolve into liquids, including breast milk. The drug was developed by Novartis, the multinational pharmaceutical company, working with the Medicines for Malaria Venture. The WHO's prequalification means the treatment meets international standards for quality, safety, and efficacy—a designation that opens the door to public-sector procurement across countries with high malaria rates, particularly in sub-Saharan Africa. Novartis has committed to making it available on a largely not-for-profit basis in malaria-endemic regions.
The human reality of this approval arrived first in Ghana. Baby Wonder was twelve weeks old when his mother, Naomi, brought him to the hospital with a high fever. He had been born underweight, and when the tests came back positive for malaria parasites in his blood, Naomi was terrified. Doctors at the hospital managed to access Coartem Baby, and today Wonder is eight months old and thriving. His case was not unique in its danger, but it became rare in its outcome—a newborn with malaria who received the right treatment at the right time.
Dr. Emmanuel Aidoo, a pediatrician at Methodist Hospital in Ankaase, Ghana, described the shift in clinical practice plainly: doctors had trained themselves to look for malaria in older children, but when newborns fell ill, the uncertainty was paralyzing. "Having a new treatment tailor-made for infants that is well tolerated gives us confidence," he said. That confidence matters. It means a doctor can act. It means a parent's fear has somewhere to go besides despair.
Dr. Tedros Adhanom Ghebreyesus, the WHO director general, framed the moment in historical terms. "For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities," he said. "But today, the story is changing." The approval of Coartem Baby is one piece of that shift—alongside new vaccines, better diagnostic tests, and next-generation mosquito nets—but it is the piece that speaks directly to the smallest patients, the ones who had no voice in the conversation until now.
Notable Quotes
For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. But today, the story is changing.— Dr. Tedros Adhanom Ghebreyesus, WHO director general
For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind.— Dr. Martin Fitchet, chief executive of Medicines for Malaria Venture
The Hearth Conversation Another angle on the story
Why did it take so long for someone to develop a treatment for babies? Wasn't this an obvious gap?
It was obvious in hindsight, but not at the time. The assumption was that infants had immunity from their mothers. That belief was so entrenched that researchers didn't think to challenge it until recently. And once you realize the gap exists, developing a drug is expensive and complex—you need to prove it's safe in a population that can't tell you how they feel.
So this is really about changing a misconception that was baked into medical practice?
Exactly. Doctors were trained to look for malaria in older children. When a newborn came in sick, they didn't even think to test for it. The disease was invisible because nobody was looking.
What changes now that Coartem Baby exists?
Doctors can act with confidence. A pediatrician in Ghana told us that before, when a newborn got malaria, "nobody seemed to know what to do." Now they have a tool. That changes everything—for the parent, for the child, for the doctor.
Is this just a pharmaceutical win, or does it actually save lives?
It saves lives. In 2024, three-quarters of the 610,000 malaria deaths were children under five in Africa. Many of those were infants. This drug won't prevent malaria, but it will treat it. And treatment, when it comes early enough, means a child lives.
Why the cherry flavor and the ability to dissolve in breast milk?
Because you're treating a baby who can't swallow pills and whose mother is likely breastfeeding. The design is practical—it meets the child where they are, not where an adult would be.