WHO Issues First Roadmap For Child-Focused Dengue Treatments As Infections Surge Globally

As dengue cases continue to rise across the globe, the World Health Organization (WHO) has released the first-ever Paediatric Drug Optimisation Process (PADO) report for dengue, outlining priorities for research, drug development and investment to accelerate the availability of child-friendly dengue treatments.

The move comes at a time when dengue is emerging as one of the fastest-growing mosquito-borne diseases globally, affecting millions of people every year and placing children at particular risk of severe illness and death. Climate change, rising temperatures, erratic rainfall patterns and rapid urban growth are expanding mosquito breeding habitats and increasing the risk of transmission.

According to the WHO, more than 14 million dengue cases and over 10,000 dengue-related deaths were reported worldwide in 2024, nearly double the number recorded in 2023.

The disease is now endemic in more than 100 countries and continues to expand into new regions due to urbanisation, climate change and changing mosquito habitats.

Despite the growing burden, there is still no licensed antiviral treatment for dengue. Management of the disease largely relies on supportive care such as fluid replacement, monitoring and treatment of complications.

Health experts say this treatment gap is especially concerning for children, who often experience different disease patterns from adults and are more vulnerable to severe dengue, shock syndrome and other life-threatening complications.

"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," said Dr. Daniel Ngamije Madandi, Director of the Department of Malaria and Neglected Tropical Diseases at WHO.

The newly released report is the outcome of a WHO-convened meeting held last year in October under the Paediatric Drug Optimisation Process, an initiative designed to ensure that medicines being developed for infectious diseases also meet the specific needs of children.

Traditionally, many medicines are first developed for adults, with paediatric formulations and dosing strategies considered much later. This often leaves children waiting years for access to suitable treatments.

WHO officials say the new guidance seeks to change that approach. "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."

The PADO exercise was conducted by WHO in collaboration with the Global Accelerator for Paediatric Formulations (GAP-f) network. It brought together researchers, clinicians, regulators, donors, pharmaceutical developers and public health experts to assess the global pipeline of dengue therapeutics and identify candidates most suitable for paediatric development.

One of the report's most important outcomes is the creation of the first-ever priority and watch lists for dengue therapeutics.

A novel monoclonal antibody candidate intended for the treatment of dengue in children has been placed on the priority list for the next three to five years. The candidate is already at an advanced stage of development and is being evaluated in children aged five years and above.

In addition, four other therapeutic candidates have been placed on a watch list for continued monitoring and future development.

Experts say these lists will help guide research funding and encourage pharmaceutical developers to focus on treatments that show the greatest promise for children.

The report also highlights the need for medicines that are easier for children to take. Young children often face difficulties swallowing tablets, and many medicines developed for adults are not available in formulations suitable for paediatric use.

The guidance also calls for earlier inclusion of children in clinical research.

At present, many dengue drug candidates are undergoing Phase 2 and Phase 3 clinical trials in adults. WHO recommends that paediatric studies should begin as soon as sufficient adult safety and efficacy data become available, rather than waiting until adult development is completed.

The report further notes that paediatric clinical trials should take into account factors commonly seen among children in dengue-endemic countries, including malnutrition, obesity and other co-existing health conditions that may influence treatment outcomes.

Welcoming the initiative, Dr. Luis Pizarro, Executive Director, Drugs for Neglected Diseases Initiative (DNDi), said the report would help align global efforts around children's needs.

"DNDi welcomes the PADO report as an important step towards aligning the dengue therapeutics community around children's needs."

"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," said Dr. Pizarro.