Overview: A historic step in pediatric malaria care
The World Health Organization has approved the first-ever child-friendly primaquine tablets for treating malaria relapse in children, marking a significant milestone in the global fight against malaria. This development, backed by collaboration between Medicines for Malaria Venture (MMV) and Fosun Pharma with funding and strategic support from Unitaid, brings a safer, easier treatment option to young patients who carry a high burden of disease in endemic regions.
Primaquine has long been a crucial drug in malaria elimination strategies because it targets dormant liver stages of the parasite responsible for relapses, particularly in Plasmodium vivax and Plasmodium ovale infections. Historically, dosing challenges and safety concerns limited its use in children. The new paediatric formulation is designed to be easier to administer and monitor, improving adherence and reducing the risk of relapse—a key win for patients, families, and health systems in high-burden areas.
Why pediatric-friendly primaquine matters
Relapses in pediatric malaria infections contribute to repeated illness, lost school days, and increased healthcare costs. A child-friendly formulation lowers the barrier to successful treatment by offering a palatable, chewable tablet option with a dosing schedule aligned to a child’s size and needs. By simplifying treatment, clinicians can deliver timely therapy, minimize prolonged parasitemia, and curb transmission in communities where malaria is endemic.
In many malaria-endemic regions, diagnostic and treatment programs already face resource constraints. The introduction of child-friendly primaquine is expected to complement existing therapies, increasing the likelihood that children complete the full course of treatment. This aligns with broader elimination goals that emphasize timely, population-wide access to effective medicines with acceptable safety profiles for vulnerable groups.
Development and support: a multi-stakeholder effort
The paediatric primaquine tablets were developed through a collaboration between MMV and Fosun Pharma, with Unitaid providing crucial support. This consortium leveraged decades of research and development in antimalarial medicines and translational science to adapt primaquine for pediatric use without compromising efficacy or safety. The effort also reflects a broader trend in malaria funding that prioritizes child health, equitable access, and sustainable supply chains.
Regulatory clearance by the WHO follows months of rigorous evaluation, including pharmacokinetic studies, safety assessments, and pediatric dosing modeling. The approval signals confidence that the new formulation can be scaled up across diverse settings—from rural clinics to busy urban health centers—where malaria remains a leading cause of illness and school absenteeism among children.
What this means for countries and communities
Health ministries and malaria programs now have an additional, evidence-based tool to reduce relapse-related morbidity among children. The paediatric primaquine tablets can be integrated into national treatment guidelines, alongside established first-line therapies and preventive measures such as insecticide-treated nets and indoor residual spraying. As countries adopt the new formulation, supply chains, caregiver education, and pharmacovigilance systems will be essential to maximize benefits and monitor safety in real-world settings.
Beyond clinical impact, the approval reinforces the importance of public-private partnerships in accelerating access to life-saving medicines. It demonstrates how patient-centered innovations—especially those addressing pediatric needs—can accelerate progress toward malaria elimination goals globally.
Looking ahead: sustaining gains against malaria
While this development is welcome news, it sits within a larger, ongoing effort to end malaria-related deaths. Continued investment in diagnostics, vaccines, vector control, and robust health systems will be critical to translating the promise of child-friendly primaquine into enduring declines in malaria incidence. Stakeholders are hopeful that the new formulation will help reduce relapse rates, protect child health, and support communities on the path to zero malaria transmission.
