About 30 million babies are born each year in malaria-endemic parts of Sub-Saharan Africa, yet until 2025 there was no antimalarial specifically made for the smallest newborns. In July 2025 Swissmedic approved Coartem Baby, the first formulation for newborns and infants under five kilograms. The tablet is dispersible, dissolves in breast milk and contains artemether and lumefantrine at doses adjusted for newborn metabolism. Novartis developed the product with the non-profit Medicines for Malaria Venture (MMV).
Several factors explain the long delay. Many medical professionals believed maternal antibodies gave newborns long protection, but MMV says the maternal shield often fades within weeks. Newborns were also commonly excluded from clinical trials for ethical and practical reasons, and it took years and new modelling to close the evidence gap. Commercial returns in the paediatric market are limited, so companies had little financial incentive; MMV notes the product is not a "blockbuster" and was introduced largely on a not-for-profit basis at the same price as existing formulations.
Regulatory weakness in many African countries was another barrier: officials had to build review capacity almost from scratch and few regulators had paediatric frameworks five years ago. Swissmedic used its Marketing Authorization for Global Health Products procedure, and eight African countries committed to fast-track national approvals within 90 days. Experts say vaccines such as RTS,S and R21 are complementary to treatments, and some observers contrasted the rapid COVID-19 vaccine response with the decades needed to develop a newborn antimalarial, calling the delay unacceptable given global priorities.
Difficult words
- malaria-endemic — areas where malaria regularly occurs
- dispersible — able to dissolve in a liquid
- metabolism — chemical processes in the body
- antibody — protein in blood that fights infectionsantibodies
- trial — a scientific test of a medicinetrials
- paediatric — relating to medical care of children
- evidence gap — missing or weak data on a question
- fast-track — to speed up an approval process
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- What problems can weak regulatory systems create when countries try to introduce new medicines? Give examples from the article.
- The article contrasts the rapid COVID-19 vaccine response with decades needed for a newborn antimalarial. Why might development and approval take longer for drugs for newborns?
- Coartem Baby was introduced largely on a not-for-profit basis at the same price as existing formulations. How could this pricing choice affect access and company incentives?
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