WHO issues first ever guidance to advance child-focused dengue treatments
The World Health Organization (WHO) has published the first ever Paediatric Drug Optimization Process (PADO) for dengue, marking a major step to prioritize child-focused dengue treatment development.
The report draws on discussions from the WHO-convened PADO meeting held on 23 October 2025, and outlines research and development priorities and investment needs to accelerate the availability of child-appropriate dengue therapeutics.
“Dengue is a growing threat to children, and silence is not an option. To prevent severe disease and save lives, children need access to safe, appropriate formulations and treatments designed for their needs” noted Dr Daniel Ngamije Madandi, Director of the Department of Malaria and Neglected Tropical Diseases at WHO.
Dengue is a mosquito-borne viral disease and a growing global public health threat, now endemic in more than 100 countries. More than 14 million dengue cases and over 10 000 dengue-related deaths were reported in 2024, around twice the number reported in 2023. Children are heavily affected, and young children are at higher risk of severe outcomes and complications. Yet there are currently no licensed treatments for dengue fever, and supportive care remains the mainstay of clinical management.
“Children must be considered from the beginning of dengue therapeutics development, not after products have already been designed for adults,” said Dr Meg Doherty, Director, Science for Health at WHO. “This report provides a practical signal to researchers, developers, regulators and funders on what is needed to ensure that future dengue treatments are appropriate, acceptable and usable for children.”
To help address this gap, the PADO for dengue exercise was convened by WHO in partnership with the Global Accelerator for Paediatric Formulations (GAP-f) network. It brought together academic researchers, clinical experts, regulators, donors, product development partnerships and other stakeholders to review the dengue therapeutics pipeline and agree on paediatric priorities.
Among its key findings, it identifies the first-ever PADO priority and watch lists for dengue, providing a clear signal to researchers, developers and funders on candidates that warrant paediatric attention. A novel monoclonal antibody for treatment of dengue in children was placed on the PADO-dengue priority list for the next 3–5 years, reflecting its more advanced stage of development, including in children from 5 years of age. Four additional candidates were included on the PADO-dengue watch list for continued attention over the medium to longer term.
The exercise further outlined paediatric-specific considerations that fed into the broader development of a target product profile for therapeutics for both non severe and severe dengue, ensuring that the specific needs of children are appropriately reflected and taken into consideration.
Beyond product design, the report calls for accelerated paediatric investigation of dengue therapeutics currently being evaluated in adults in Phase 2 and 3 development. It emphasizes that paediatric studies should be planned early, once sufficient adult data become available, and that trial design should reflect the clinical realities of paediatric dengue, including differences in disease presentation, malnutrition, obesity and other relevant comorbidities such as obesity and malnutrition.
“DNDi welcomes the PADO report as an important step towards aligning the dengue therapeutics community around children’s needs,” said Dr Luis Pizarro, Executive Director, Drugs for Neglected Diseases initiative (Dndi). “By identifying priority candidates, formulation considerations and research gaps, the report can help developers and funders focus efforts where they can have the greatest impact for children living in dengue-endemic settings.”
Designed as a practical reference, the report to be used by researchers, product developers, funders, regulators, market-shaping entities and national programmes, underscores the importance of integrating paediatric consideration into every stage of product development.
