The first malaria treatment for babies has been approved by the World Health Organization, opening the door to widespread use around the globe.
In parts of Africa, up to 18% of children under six months will be infected with malaria, but there has historically been no safe treatment for the smallest of them. There were 610,000 deaths from malaria in 2024, about three quarters of which were under-fives in Africa.
The WHO said infants with malaria had until now been treated with formulations designed for older children “which increase the risk of dosing errors, side effects and toxicity”.
Medical leaders hope that Coartem Baby, which can be used to treat infants as small as 2kg (4.4lb), will fill the treatment gap. The drug comes as sweet cherry-flavoured tablets that can be dissolved into liquids, including breast milk.
“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.”
Coartem Baby now has WHO prequalification, which indicates it meets international standards of quality, safety and efficacy, and will enable public-sector procurement for many countries with high rates of malaria, particularly in sub-Saharan Africa.
Ghebreyesus said new vaccines and diagnostic tests, alongside next-generation mosquito nets, were helping to turn the tide against the mosquito-borne disease.
Coartem Baby contains two antimalarial drugs, artemether and lumefantrine, and was developed by the multinational pharmaceutical company Novartis and the Medicines for Malaria Venture (MMV).
The development follows increasing research challenging the historical misconception that young babies cannot be infected with malaria because they retain immunity passed on by their mothers during pregnancy and breastfeeding.
Dr Martin Fitchet, chief executive of MMV, said: “For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind.” He said the WHO ruling was “a major public-health milestone”.
The treatment has already been introduced in Ghana. Baby Wonder, now eight months old, was among the first patients to receive the drug, when he was 12 weeks old. He had been taken to hospital with a high fever, and tests confirmed elevated levels of the malaria parasite in his blood.
“I was very scared when my son got malaria because he was born underweight,” said his mother, Naomi.
Doctors at the hospital managed to coordinate access to Coartem Baby, and today Wonder is healthy and thriving.
“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,” said Dr Emmanuel Aidoo, a paediatrician at Methodist hospital in Ankaase, Ghana. “Having a new treatment tailor-made for infants that is well tolerated gives us confidence.”
Novartis said it would make the treatment available “on a largely not-for-profit basis in malaria-endemic regions”.
The Gates Foundation, which contributes funding towards the independent journalism produced on the Guardian’s Global development site, is also among the donors to the Medicines for Malaria Venture
