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논문 기본 정보

자료유형
학술저널
저자정보
Kim Seyoung (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Korea.) Kim Jeong Ah (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Health Convergence, College of Science and Industry Convergence, Ewha Womans University, Seoul, Korea.) Park Hyesook (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Preventive Medicine, College of Medicine, Graduate Program in System Health Science and Engineering, Ewha Womans Universit) Park Sohee (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Health Informatics and Biostatistics, Graduate School of Public Health, Yonsei University, Seoul, Korea.) Oh Sanghoon (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Korea.) Jung Seung Eun (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Radiology, Eunpyeong St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea.) Shin Hyoung-Shik (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Infectious Diseases, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea.) Lee Jong Koo (COVID-19 Vaccine Safety Research Center, Seoul, Korea.National Cancer Center, Goyang, Korea.) Han Hee Chul (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Physiology, College of Medicine and Neuroscience Research Institute, Korea University, Seoul, Korea.) Woo Jun Hee (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Medicine Korea Tourism College Eldercare Center, Icheon, Korea.) Park Byung-Joo (COVID-19 Vaccine Safety Research Center, Seoul, Korea.National Academy of Medicine of Korea, Seoul, Korea.) Choi Nam-Kyong (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Health Convergence, College of Science and Industry Convergence, Ewha Womans University, Seoul, Korea.) Kim Dong-Hyun (COVID-19 Vaccine Safety Research Center, Seoul, Korea.Department of Social and Preventive Medicine, Hallym University College of Medicine, Chuncheon, Korea.)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.39 No.26
발행연도
2024.7
수록면
1 - 11 (11page)
DOI
10.3346/jkms.2024.39.e220

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초록· 키워드

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During the coronavirus disease 2019 (COVID-19) pandemic, conclusively evaluating possible associations between COVID-19 vaccines and potential adverse events was of critical importance. The National Academy of Medicine of Korea established the COVID-19 Vaccine Safety Research Center (CoVaSC) with support from the Korea Disease Control and Prevention Agency to investigate the scientific relationship between COVID-19 vaccines and suspected adverse events. Although determining whether the COVID-19 vaccine was responsible for any suspected adverse event necessitated a systematic approach, traditional causal inference theories, such as Hill's criteria, encountered certain limitations and criticisms. To facilitate a systematic and evidence-based evaluation, the United States Institute of Medicine, at the request of the Centers for Disease Control and Prevention, offered a detailed causality assessment framework in 2012, which was updated in the recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) in 2024. This framework, based on a weight-of-evidence approach, allows the independent evaluation of both epidemiological and mechanistic evidence, culminating in a comprehensive conclusion about causality. Epidemiological evidence derived from population studies is categorized into four levels—high, moderate, limited, or insufficient—while mechanistic evidence, primarily from biological and clinical studies in animals and individuals, is classified as strong, intermediate, weak, or lacking. The committee then synthesizes these two types of evidence to draw a conclusion about the causal relationship, which can be described as “convincingly supports” (“evidence established” in the 2024 NASEM report), “favors acceptance,” “favors rejection,” or “inadequate to accept or reject.” The CoVaSC has established an independent committee to conduct causality assessments using the weightof-evidence framework, specifically for evaluating the causality of adverse events associated with COVID-19 vaccines. The aim of this study is to provide an overview of the weight-ofevidence framework and to detail the considerations involved in its practical application in the CoVaSC.

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