WHO approves first child-friendly primaquine formulations for malaria treatment

• First-ever paediatric formulations of primaquine prequalified by WHO, paving the way for improved access for children in malaria-endemic regions.
• Children account for over 74% of malaria deaths globally, making the availability of quality-assured antimalarial formulations critical.
• These medicines are a game-changer on the path to malaria elimination, helping to prevent relapse and transmission.

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.”

“Fosun Pharma is proud to partner with MMV on child‑friendly dispersible primaquine,” said Mr Chen Yuqing, Chairman of Fosun Pharma. “This WHO prequalification is an important step toward improving paediatric care and making effective antimalarial treatment more accessible to the children who need it.”

“Children are disproportionately affected by malaria, which takes a toll on their health, education and future. Without putting children at the center of the response, we can’t beat malaria,” said Dr Philippe Duneton, Executive Director at Unitaid. “Unitaid’s support to PAVE in introducing the first child-friendly formulations of primaquine marks a significant step towards better protecting one of the most vulnerable populations.”

With children accounting for over 76% of malaria deaths globally,[1] 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[2]: administered over 7 or 14 days, primaquine helps eliminate the dormant liver stage of 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 falciparum malaria[3] 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.

[1] WHO World Malaria Report 2024

[2] WHO Malaria Treatment guidelines, section 5.2.1.5 Uncomplicated malaria caused by P. vivax, P. ovale, P. malariae or P. knowlesi.

[3] WHO: Policy brief on single-dose primaquine as a gametocytocide in Plasmodium falciparum malaria

About MMV

MMV is a Swiss not-for-profit product development partnership working to deliver a portfolio of accessible medicines with the power to treat, prevent and eliminate malaria. Born in 1999, out of a need for greater health equity, we close critical gaps in research, development and access – working “end-to-end” to expand the use of existing antimalarials and innovate new compounds to protect public health. This starts with women and children.

It’s working. Since 1999, over 1.3 billion people have been effectively treated or protected from our co-developed medicines. We cannot stop now.

With over a quarter of a billion malaria cases and nearly 600,000 deaths reported in 2023, progress towards disease elimination has stalled. MMV is part of an ecosystem of partners determined to change this. Bringing public and private sector partners together, we pioneer new solutions that align with local and global health priorities and promote the equitable development of effective and affordable products that work to help end malaria and advance health for all.

For more information, visit www.mmv.org

Follow MMV on social media: X | LinkedIn | YouTube | Facebook

About Unitaid

Unitaid is a global health organization that saves lives by making new health products available and affordable for people in low- and middle-income countries. Unitaid works with partners to identify innovative treatments, tests and tools, help tackle the market barriers that are holding them back, and get them to the people who need them most – fast. Since Unitaid was created in 2006, the organization has unlocked access to more than 100 groundbreaking health products to help address the world’s biggest health challenges, including HIV, TB and malaria; women’s and children’s health; and pandemic prevention, preparedness and response. Every year, more than 300 million people benefit from the products Unitaid has helped roll out. Unitaid is hosted by the World Health Organization.