For the first time in history, a doctor treating a malaria-infected newborn in Borno State or Kebbi or Anambra will have a drug that was actually made for that child. The World Health Organization this week granted prequalification to Coartem Baby, a fixed-dose artemether-lumefantrine formulation designed specifically for infants — ending a decades-long gap that left the world's smallest and most vulnerable malaria patients without a safe, approved treatment of their own.
The scale of the problem this drug was built to solve is staggering. In the highest-burden zones of sub-Saharan Africa, up to 18 percent of children under six months carry a malaria infection — yet until now, clinicians had no option except to improvise, breaking tablets designed for adults or older children into rough fractions and hoping the dosing would hold. For a generation of mothers and healthcare workers across northern Nigeria, the Democratic Republic of Congo, and the Sahel, that improvisation was simply the standard of care.
Nigeria sits at the epicentre of this crisis. The country accounts for roughly 27 percent of global malaria deaths — more than any other nation — and carries a disproportionate share of the infant mortality embedded in that figure. The 610,000 malaria deaths recorded worldwide in 2024 were dominated by children under five, with the under-six-months cohort representing the most under-counted and under-served slice of that toll. Many of those deaths occurred not because a treatment did not exist in principle, but because no formulation existed that could safely deliver the right compound at the right dose to a body weighing less than five kilograms.
The prequalification of Coartem Baby by the WHO is not a regulatory approval from Nigeria's NAFDAC, but it is the critical upstream step that unlocks the drug for procurement through UNICEF, the Global Fund, and the international aid architecture that supplies most of Nigeria's public-sector health facilities. WHO prequalification signals to governments and procurement agencies that the product meets internationally accepted standards of safety, efficacy, and quality — and in practical terms, it clears the path for the drug to move into the supply chains that serve primary healthcare centres across Zamfara, Plateau, Taraba, and every other high-burden state.
WHO Director-General Dr Tedros Adhanom Ghebreyesus described the approval as a "major public health milestone", noting that the absence of a safe infant formulation had been one of the most glaring structural failures in global malaria control for years. Novartis, the Swiss pharmaceutical company that manufactures Coartem, developed the baby formulation as a dispersible granule that dissolves in a small amount of water — a delivery method that accounts for the reality of treating an infant in a rural clinic or a community health worker's hands, not a hospital ward.
For Nigeria, the question now is speed of access. NAFDAC will need to fast-track its own review of the formulation, and the Federal Ministry of Health will need to update treatment guidelines that currently leave infants in an uncomfortable grey zone. The National Malaria Elimination Programme, already under pressure to hit WHO targets, will be watching closely to see whether the Global Fund and bilateral donors prioritise Coartem Baby in their next procurement cycles. Health advocates in Lagos and Abuja have already begun pressing for the drug to be included in the national essential medicines list without delay.
A drug that was made for babies finally exists — the only remaining question is whether the systems meant to protect Nigeria's children can move fast enough to put it in the right hands before another rainy season begins.
