WHO approves first child-friendly "primaquine" to treat malaria relapse

Medicines for Malaria Venture (MMV) and Unitaid welcome the World Health Organization (WHO)’s prequalification of two child-friendly formulations of primaquine, a highly effective medicine that prevents malaria relapse and transmission. Until now, primaquine launched over 60 years ago, was not available in quality assured, child-friendly formulations, leaving one of the most vulnerable populations at risk of repeated illness.

Through the Partnership for Vivax Elimination (PAVE) and funded by Unitaid, MMV partnered with Fosun Pharma to develop 2.5 mg and 5 mg dispersible tablets tailored for paediatric use. These tablets are flavor-masked, easier to administer, support improved adherence, and are suitable for children weighing over 5 kg. The new formulations meet WHO’s international standards for quality, safety and efficacy – an endorsement that will support countries' decision-making to include them in their treatment guidelines and make them available to children.

“Having quality-assured paediatric primaquine in a dispersible format is a game-changer for elimination,” said Dr Martin Fitchet, Chief Executive Officer at MMV. “It means national programmes can now treat children more effectively, helping to break the cycle of relapse and transmission.”

Mr Chen Yuqing, Chairman of Fosun Pharma said “This WHO prequalification is an important step toward improving paediatric care and making effective antimalarial treatment more accessible to the children who need it.”

With children under 5 years accounting for over 74% of malaria deaths globally, having a quality-assured paediatric option is critical for malaria elimination efforts. WHO prequalification not only validates the quality of these formulations but also accelerates the uptake by global health donors, such as the Global Fund, which require new medicines to be prequalified to be eligible for procurement, helping ensure timely availability in malaria-endemic regions.

Primaquine plays a critical role in combatting the two main species of parasite that cause malaria in humans:

1. Plasmodium vivax: administered over 7 or 14 days, primaquine helps eliminate the dormant liver stage of P. vivax malaria, which can cause relapse weeks or even months after the initial infection. Without treatment, children remain vulnerable to repeated illness, leading to anaemia and missed school days, undermining both health and development.
2. Plasmodium falciparum: WHO recommends a single low dose of primaquine to block the transmission of P. falciparum malaria by killing gametocytes (the sexual stage of the parasite reproduction cycle). By preventing onward transmission from infected patients back to mosquitoes, primaquine helps limit the rise of drug resistance, one of the greatest threats to malaria elimination.

This milestone is an important step towards making sure that no child is left behind on the path towards malaria elimination.