Every year, malaria kills around 610,000 people globally. Three quarters of those deaths are children under five. Yet until now, there was no malaria treatment specifically designed for the youngest and smallest infants. Doctors were giving newborns doses meant for older children, and hoping for the best.
That changed last week.
5 Quick Facts:
- WHO pre-qualified Coartem® Baby, the first malaria treatment for infants weighing 4.5 kg or less.
- It works on newborns as small as 2 kg.
- Around 30 million babies are born each year in malaria-endemic areas of Africa.
- The treatment was developed by Novartis and Medicines for Malaria Venture (MMV).
- It is already being rolled out in Ghana.
What is a Coartem® Baby?
Coartem® Baby is an artemisinin-based combination treatment using artemether-lumefantrine. It is the first WHO-approved malaria treatment formulated specifically for young infants weighing 4.5 kilograms or less, including newborns from 2 kg.
Before this, no such formulation existed. Doctors treating infants with malaria had no choice but to use drug doses designed for older children. That approach raised serious risks.
WHO Director General Dr. Tedros Adhanom Ghebreyesus stated that infants with malaria were being treated with formulations intended for older children, which increased the risk of dosing errors, side effects, and toxicity.
That is a significant patient safety problem. And it went unaddressed for decades.
Why is this Approval Important?
|
Factor |
Detail |
|
Who it helps |
Infants weighing 4.5 kg or less |
|
Minimum weight |
2 kg (newborns) |
|
Deaths it targets |
~457,500 child malaria deaths annually |
|
Babies at risk annually |
~30 million in malaria-endemic Africa |
|
Countries in rollout |
Ghana (initial), 8 more in approval pipeline |
The combination treatment aims to fill a longstanding gap in treatments available for children under five, who make up three quarters of the estimated 610,000 malaria deaths worldwide.
How Did it Get Approved?
The path to WHO approval moved through several stages.
Step 1: Swissmedic Approval (July 2025)
Swissmedic, the Swiss drug regulator, gave the treatment its first approval in July 2025. Eight African countries joined in on Swissmedic’s Marketing Authorisation for Global Health Products process as well, including:
- Burkina Faso
- Côte d’Ivoire
- Kenya
- Malawi
- Mozambique
- Nigeria
- Uganda
- Tanzania
This process helps low-income countries build regulatory trust and fast-track their own national approvals.
Step 2: WHO Pre-Qualification (May 2026)
Getting WHO pre-qualification really matters. It’s what opens doors for major health funders around the world. Groups like UNICEF and the Global Fund rely on WHO’s list of approved products when they decide what to buy for low-income countries. Without that stamp of approval, products don’t even make it onto their radar.
Simply put: without WHO pre-qualification, large-scale distribution at affordable prices is nearly impossible.
What Happens Next?
Pre-qualification is a major step. But it is not the last one.
The next important milestone will be for the medicine to be added to WHO treatment guidelines, which is another requirement for Global Fund bulk procurement of new medicines and vaccines, along with registration of the treatment in national regulatory systems.
Pierre Hugo, MMV Vice President of Access and Product Management, described the broader significance: Coartem® Baby represents a breakthrough not just in science, but in equity, closing a long-standing treatment gap for the smallest and most vulnerable malaria patients.
Who Made this Happen?
The artemisinin-based combination treatment was developed by Novartis together with Medicines for Malaria Venture (MMV).
MMV, based in Geneva, is a non-profit that works to create affordable malaria medicines for people who need them most. Novartis, the Swiss drug company, played a big part with the original Coartem® for adults. Now, with this infant version, they’ve pushed that effort even further, finally getting help to the youngest and most vulnerable patients.
The Bigger Picture: A Multi-Front Fight Against Malaria
This approval does not stand alone. Earlier this month, WHO also pre-qualified three new rapid diagnostic tests that can detect strains of malaria that older tests miss.
Dr. Tedros framed it clearly: together with vaccines, new diagnostics, and next-generation mosquito nets, it is another step towards a malaria-free world.
Key tools now in play against malaria:
- Coartem® Baby (treatment for newborns and small infants) | WHO pre-qualified
- New rapid diagnostic tests for resistant malaria strains | WHO pre-qualified
- RTS,S malaria vaccine (for children over 5 months)
- Next-generation insecticide-treated mosquito nets
What this Means on the Ground
Consider what this looked like before. A three-month-old infant arrives at a hospital in Ghana with malaria. The doctor has no approved infant-specific treatment. The family is in a low-income area with limited access to specialized care. The doctor uses an adult formulation, tries to adjust the dose manually, and hopes the child tolerates it.
Wonder Nartey, a healthy eight-month-old, was one of the first infants to receive Coartem® Baby when he was hospitalised at three months at The Methodist Hospital in Muwasi, Ghana. He recovered well.
That outcome is now reproducible, at scale, with a treatment designed for him from day one.
Frequently Asked Questions
What is Coartem® Baby? It is the first WHO-approved malaria treatment formulated for infants weighing 4.5 kg or less, including newborns from 2 kg. It uses artemether-lumefantrine.
Why did infants not have a dedicated malaria treatment before? Historically, drug development focused on older children and adults. Infants were given adjusted doses of treatments not designed for their weight or physiology, creating dosing and safety risks.
Which countries will receive Coartem® Baby first? Ghana is the first country in active rollout. Eight additional African countries participated in the regulatory approval process, including Nigeria, Kenya, Uganda, and Tanzania.
What is WHO pre-qualification? This is the WHO’s official seal of approval, showing a medicine meets its standards for quality, safety, and effectiveness. Without it, groups like UNICEF or the Global Fund can’t buy large amounts of treatments to send to low-income countries.
How many children die from malaria each year? Approximately 610,000 people die from malaria annually. Around 75% of those deaths are children under five.
Final Word
Decades of children received malaria treatments never built for them. Dosing guesswork. Unnecessary risk. Preventable harm.
Coartem® Baby is not just a new drug. It is the correction of a long-standing gap that should have been filled much sooner. With WHO pre-qualification now secured and rollout underway in Ghana, the focus shifts from science to access, getting this treatment into the hands of doctors treating the world’s most vulnerable patients.
