Licensure of Chikungunya Vaccines Without Formal Efficacy Data: A Case Study in Regulatory Strategy and Real-World Evidence.

This presentation reviews regulatory pathways for vaccine licensure without phase 3 efficacy trials, using the case of Chikungunya Vaccines to illustrate the role of surrogate endpoints and accelerated approvals. It highlights the health burden of Chikungunya disease, the scientific justification for surrogate markers, and the regulatory requirements to confirm vaccine benefit–risk after early access.