Biodefense and emergency use authorization: different originations, purposes, and evolutionary paths of institutions in the United States and South Korea

Abstract

Background: Emergency-use-authorization (EUA) is the representative biodefense policy that allows the use of unlicensed medical countermeasures or off-label use of approved medical countermeasures in response to public health emergencies. This article aims to determine why the EUA policies of the United States and South Korea produced drastically different outcomes during the COVID-19 pandemic, and how these outcomes were determined by the originations and evolutionary paths of the two policies. Method: Historical institutionalism (HI) explains institutional changes—that is, how the institution is born and how it evolves—based on the concept of path dependency. However, the HI analytical narratives remain at the meso level of analysis in the context of structure and agency. This article discusses domestic and policy-level factors related to the origination of the biodefense institutions in the United States and South Korea using policy-learning concepts with the Event-related Policy Change Model. Results: The 2001 anthrax letter attack (Amerithrax) and the 2015 Middle East Respiratory Syndrome (MERS) outbreak prompted the establishment of biodefense institutions in the United States and South Korea, respectively. Due to the different departure points and the mechanism of path dependency, the two countries’ EUAs evolved in different ways—the United States EUA reinforced the Post-Exposure Prophylaxis (PEP) function, while the South Korea EUA strengthened the Non-Pharmaceutical Intervention (NPI) function. Conclusions: The evolution and outcomes of the two EUAs are different because both policies were born out of different needs. The United States EUA is primarily oriented toward protecting homeland security against CBRN (chemical, biological, radiological, and nuclear) threats, whereas the South Korea EUA is specifically designed for disease prevention against infectious disease outbreak.