COVID-19 Vaccine Safety Research Center, Seoul, Korea.
Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Korea.
J Korean Med Sci. 2024 Jul 8;39(26):e220. doi: 10.3346/jkms.2024.39.e220.
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 weight-of-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-of-evidence framework and to detail the considerations involved in its practical application in the CoVaSC.
在 2019 冠状病毒病（COVID-19）大流行期间，对 COVID-19 疫苗和潜在不良事件之间可能存在的关联进行结论性评估至关重要。韩国国家医学科学院（Korean Academy of Medical Sciences）在韩国疾病控制与预防机构（Korea Disease Control and Prevention Agency）的支持下，成立了 COVID-19 疫苗安全研究中心（COVID-19 Vaccine Safety Research Center，CoVaSC），以调查 COVID-19 疫苗与疑似不良事件之间的科学关系。虽然确定 COVID-19 疫苗是否应对任何疑似不良事件负责需要采取系统的方法，但传统的因果推理理论，如希尔标准（Hill's criteria），存在一定的局限性和批评。为了促进系统和基于证据的评估，美国医学科学院（Institute of Medicine）应疾病控制与预防中心（Centers for Disease Control and Prevention）的要求，于 2012 年提供了详细的因果关系评估框架，该框架在 2024 年由国家科学院、工程院和医学院（National Academies of Sciences, Engineering, and Medicine，NASEM）的最新报告中进行了更新。该框架基于证据权重方法（weight-of-evidence approach），允许对流行病学证据和机制证据进行独立评估，最终得出关于因果关系的全面结论。基于人群研究的流行病学证据分为四级——高、中、低或不足——而主要来自动物和个体的生物学和临床研究的机制证据则分为强、中、弱或缺乏。然后，委员会综合这两种类型的证据来得出因果关系的结论，可以描述为“令人信服地支持”（“证据确立”在 2024 年 NASEM 报告中）、“倾向于接受”、“倾向于拒绝”或“不足以接受或拒绝”。CoVaSC 成立了一个独立的委员会，使用证据权重框架进行因果关系评估，专门评估与 COVID-19 疫苗相关的不良事件的因果关系。本研究旨在概述证据权重框架，并详细说明其在 CoVaSC 中的实际应用所涉及的考虑因素。
