WHO prequalifies first malaria treatment designed for youngest vulnerable patients

Ahead of World Malaria Day on 25 April, the World Health Organization (WHO) has announced a significant step forward in the fight against malaria with the prequalification of the first treatment developed specifically for newborns and young infants weighing between two and five kilograms. The prequalification designation indicates that the medicine meets international standards of quality, safety and efficacy, and will help to expand access to quality-assured treatment for one of the most underserved patient groups.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-GeneralFor 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."

New prequalified tests

On 14 April 2026, WHO also prequalified three new rapid diagnostic tests (RDTs) designed to address emerging diagnostic challenges for malaria. The most common malaria RDTs for P.falciparum parasite work by detecting the protein, known as HRP2. But based on reported studies and surveys in 46 countries, some strains of the malaria parasite have lost the gene that makes this protein – so they become "invisible" to HRP2-based RDTs, leading to false-negative results. In countries in the Horn of Africa, up to 80% of cases were missed, leading to delayed treatment, severe illness, and even death.

The new tests address this issue by targeting a different parasite protein (pf-LDH) that the malaria parasite cannot easily shed. They provide a reliable, quality-assured alternative where HRP2-based tests are failing. WHO now recommends that countries switch to these alternative RDTs when more than 5% of cases are missed due to pf-hrp2 deletions. This ensures accurate diagnosis, appropriate treatment, and protects hard-won malaria control gains – especially for the most vulnerable communities.

The announcements come as WHO and partners launch the 2026 World Malaria Day campaign, "Driven to End Malaria: Now We Can. Now We Must." The theme is a rallying cry to seize the moment – to protect lives now and fund a malaria-free future.

Twenty-five countries are now rolling out malaria vaccines, protecting millions of children, and next-generation mosquito nets make up 84% of all new nets distributed. These advances demonstrate what is possible when all partners work together to innovate and deliver on the promises towards ending malaria for all.

Source:

The World Health Organization