The World Health Organization has approved the first-ever paediatric primaquine tablets for malaria treatment — a major milestone in global malaria elimination efforts.
Developed by Medicines for Malaria Venture (MMV) and Fosun Pharma with support from Unitaid, the new child-friendly primaquine formulations are highly effective in preventing both malaria relapse and transmission.
Although primaquine has been available for more than 60 years, it had never before come in quality-assured, child-appropriate versions, leaving young children among the most at-risk for recurrent infections.
Through the Partnership for Vivax Elimination (PAVE), and with funding from Unitaid, MMV and Fosun Pharma created 2.5 mg and 5 mg dispersible tablets specifically designed for paediatric use.
These tablets are flavour-masked, easy to administer, promote better treatment adherence, and are suitable for children weighing more than 5 kg.
The new formulations meet WHO’s global standards for quality, safety and efficacy — an endorsement that will guide countries as they update treatment guidelines and work to make the medicines accessible to children.
MMV Chief Executive Officer Dr. Martin Fitchet described the availability of quality-assured, dispersible paediatric primaquine as a transformational advance for malaria elimination.
“It means national programmes can now treat children more effectively, helping to break the cycle of relapse and transmission,” he said.
Unitaid Executive Director Dr. Philippe Duneton noted that children bear a disproportionate burden of malaria, affecting their health, education and long-term prospects. He emphasised that without prioritising children, malaria cannot be eradicated.
He added that Unitaid’s support to PAVE in introducing the first child-friendly primaquine formulations represents a major step toward better protecting this highly vulnerable population.
With children under five accounting for more than 74% of global malaria deaths, access to a quality-assured paediatric option is essential for advancing malaria elimination.
WHO prequalification not only confirms the quality of new formulations but also accelerates their adoption by global health donors, such as the Global Fund, which require medicines to be prequalified for procurement — thereby helping ensure they reach malaria-endemic regions quickly.
Primaquine is vital for treating the two main malaria-causing parasites in humans. Given over seven or 14 days, it clears the dormant liver stage of P. vivax, which can trigger relapse weeks or months after the initial infection.
Without this treatment, children remain vulnerable to repeated episodes of illness, leading to anaemia, missed school days and long-term impacts on their health and development.
