미국과 유럽의 코로나19 백신 안전성 모니터링을 위한 특별 관심 대상의 이상사례

The List of Adverse Event of Special Interests selected for Covid-19 Vaccine Safety Monitoring in the United States and Europe

Since the outbreak of the Covid-19 pandemic, multinational pharmaceutical companies have accelerated vaccine development at an unprecedentedly rapid pace. The safety concerns about Covid-19 vaccines may lead to the increasing number of people with vaccine distrust, making it difficult to maintain the vaccination rate for obtaining herd immunity. Therefore, some countries, including the United States (US) and Europe, have selected adverse event of special interests (AESIs) and planned to conduct vaccine safety monitoring. In the US, the vaccine passive surveillance systems such as Vaccine Adverse Event Reporting System (VAERS) and the active surveillance systems, including the Biologics Effectiveness and Safety (BEST) Initiative and Vaccine Safety Datalink (VSD) have selected AESIs for COVID-19 vaccines. In Europe, the Safety Platform for Emergency vACcines (SPEAC) project and the vACCine Covid-19 monitoring readinESS (ACCESS) project have selected AESIs, respectively. We confirmed the number of VAERS, BEST, VSD, SPEAC, and ACCESS AESIs, respectively 16, 15, 20, 34, and 38. We identified among the 52 AESIs included in the US and Europe that were commonly contained anaphylaxis, Guillain-Barre syndrome (GBS), myopericarditis/ myocarditis/ pericarditis, multisystem inflammatory syndrome (MIS) and stroke. This paper identified the backgrounds and characteristics of AESIs for COVID-19 vaccines in the US and Europe.