WHO Prequalifies First Malaria Treatment for Newborns Ahead of World Malaria Day

The World Health Organization (WHO) has prequalified artemether-lumefantrine as the first antimalarial treatment formulated specifically for newborns and young infants weighing between 2 and 5 kilograms. The prequalification confirms that the medicine meets international standards for quality, safety, and efficacy.

This development allows for public sector procurement and aims to address treatment needs for approximately 30 million babies born annually in malaria-endemic areas of Africa. Previously, infants in this weight range received treatments intended for older children, which raised risks of dosing errors, side effects, and toxicity.

The new formulation is intended to reduce these risks.

14, 2026, WHO prequalified three new rapid diagnostic tests (RDTs) that target the pf-LDH protein in malaria parasites. These tests provide an alternative to common RDTs that detect the HRP2 protein, which some parasite strains lack due to gene deletions.

Studies and surveys in 46 countries have identified such deletions, leading to false-negative results in HRP2-based tests. In regions like the Horn of Africa, up to 80% of cases have been missed by HRP2 tests, resulting in delayed treatment and increased severity of illness.

WHO recommends switching to these alternative RDTs when more than 5% of cases are missed due to pf-hrp2 deletions.

to the World Malaria Report 2025, there were an estimated 282 million malaria cases and 610,000 deaths in 2024, an increase from 2023. Forty-seven countries have been certified malaria-free, and 37 countries reported fewer than 1,000 cases in 2024. Since 2000, an estimated 2.3 billion malaria infections have been prevented and 14 million lives saved worldwide.

Twenty-five countries are implementing malaria vaccines, and next-generation mosquito nets accounted for 84% of nets distributed in recent efforts. WHO reported challenges including drug resistance, insecticide resistance, diagnostic failures, and reductions in international development assistance.

“For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities. 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." — Dr Tedros Adhanom Ghebreyesus, WHO Director-General. The announcements coincide with the launch of the 2026 World Malaria Day campaign on April 25, themed 'Driven to End Malaria: Now We Can. Now We Must.'”