From controversy to confidence: Strengthening dengue vaccines safety reporting.

Dengue fever, driven by four serotypes of the Dengue virus and transmitted by Aedes aegypti, presents a major global health threat, impacting billions in tropical and subtropical regions. Severe cases, such as Dengue Shock Syndrome, result in significant mortality, particularly without prompt intervention, placing immense strain on healthcare systems in resource-limited settings. Dengue vaccines-Dengvaxia, Qdenga, and TV003/TV005 (NIH dengue vaccine) -offer potential for control, yet their implementation has been challenged by safety issues, including heightened risks in seronegative individuals, presumably due to antibody-dependent enhancement, though the precise mechanisms remain under investigation. Although newer vaccines show promise in efficacy and safety, their real-world performance across diverse populations remains poorly understood due to insufficient post-marketing surveillance. This commentary evaluates the deficiencies in adverse event reporting, identifying key obstacles such as inconsistent practices, inadequate infrastructure, and weak regulatory frameworks in endemic areas. Drawing on established pharmacovigilance models from the United States and United Kingdom, we propose real-time, transparent reporting systems to strengthen safety monitoring. Recommendations include standardized digital tools, capacity enhancement, and global data-sharing initiatives to ensure interoperability and accessibility. The erosion of public trust following past vaccine controversies highlights the urgent need for transparency to bolster acceptance and inform policy. By integrating advanced surveillance with international cooperation, these measures can refine risk-benefit assessments, rebuild confidence in immunization programs, and maximize the protective impact of dengue vaccines, ultimately reducing the burden on vulnerable populations worldwide.