Modeling-Based Improvement of Korea’s Vaccine Emergency Use Authorization System : Focusing on a pandemic response perspective

This study proposes improvements to expedite vaccine development and emergency authorization during pandemics. After COVID-19, the Korea Disease Control and Prevention Agency set a goal to supply vaccines within 100 or 200 days of an outbreak. However, the current domestic regulatory system may limit rapid responses in emergencies. In particular, biosafety regulations concerning living modified organisms and high-risk pathogens can delay early vaccine development. This study analyzes the current regulatory framework and models practical improvements by referencing CEPI’s global strategies. Key suggestions include flexible non-clinical and clinical trials, immunogenicity-based conditional approval, improved facility and quality regulations, and temporary exemptions from biosafety rules. These measures may strengthen South Korea’s operational readiness for future pandemics.