Advancing chikungunya vaccine development through regulatory science

The escalating global spread of chikungunya virus, exemplified by the 2025 local outbreak in Guangdong Province, China, underscores the urgent need for effective vaccination strategies. This paper discusses advancements in chikungunya vaccine development through the lens of regulatory science. We reviewed recent progress in vaccine platforms, including the live-attenuated IXCHIQ ® and VLP-based Vimkunya ® , as well as the emerging mRNA candidates, highlighting their immunogenicity and safety profiles. We further addressed unique challenges in chikungunya vaccine development, such as viral genetic diversity, intermittent outbreaks, and ethical and practical barriers to conducting traditional efficacy trials. To overcome these, we proposed innovative regulatory strategies to accelerate approval, including: (1) surrogate endpoints based on neutralizing antibodies supported by animal challenge models; (2) streamlined chemistry, manufacturing, and controls and nonclinical/ clinical study requirements through platform technology leveraging; and (3) integrated lifecycle risk management with enhanced postmarketing surveillance. Drawing on experience with platform-based vaccine regulation, we emphasize the importance of regulatory agility, international collaboration, and science-driven policy to facilitate the rapid development and deployment of safe, effective, and broadly protective chikungunya vaccines against future arbovirus threats.