The World Health Organization (WHO) has prequalified the first-ever malaria treatment specifically designed for newborns and young infants, marking a major step in addressing a long-standing treatment gap for the most vulnerable patients.

Announced ahead of World Malaria Day on April 25, the move clears the use of a tailored formulation of artemether-lumefantrine for babies weighing between two and five kilograms. Prequalification means the medicine meets global standards for quality, safety, and efficacy, enabling wider procurement and distribution through public health systems.

Until now, infants with malaria were treated using drugs formulated for older children, increasing the risk of incorrect dosing, side effects, and toxicity. The newly approved formulation is expected to improve treatment accuracy for an estimated 30 million babies born each year in malaria-endemic regions, particularly in Africa.

“For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities,” said Tedros Adhanom Ghebreyesus, Director-General of WHO. “But today, the story is changing. New vaccines, diagnostic tests, next-generation mosquito nets and effective medicines, including those adapted for the youngest, are helping to turn the tide. Ending malaria in our lifetime is no longer a dream – it is a real possibility, but only with sustained political and financial commitment. Now we can. Now we must.”

Alongside the new treatment, WHO has also prequalified three rapid diagnostic tests (RDTs) aimed at tackling emerging detection challenges. Traditional tests often rely on identifying the HRP2 protein produced by the malaria parasite. However, in several regions, including parts of the Horn of Africa, some parasite strains have evolved to lack the gene responsible for this protein, making them undetectable by standard tests.

The new RDTs instead target an alternative protein known as pf-LDH, which is less likely to be absent in parasite strains. WHO has recommended that countries switch to these tests when more than 5% of malaria cases are missed due to such genetic mutations, in order to ensure timely diagnosis and treatment.

The developments come amid mixed global progress in tackling malaria. According to the latest global estimates, there were around 282 million cases and 610,000 deaths in 2024, reflecting a slight increase from the previous year. While dozens of countries have achieved malaria-free status and several others report low case numbers, overall progress has slowed due to challenges such as drug and insecticide resistance, diagnostic gaps, and declining international funding.

Despite these hurdles, global efforts since 2000 have helped prevent an estimated 2.3 billion infections and saved 14 million lives. At present, 25 countries are rolling out malaria vaccines, and next-generation mosquito nets now account for the majority of new distributions, signalling continued momentum in the fight against the disease.