A Causality Assessment Framework for COVID-19 Vaccines and Adverse Events at the COVID-19 Vaccine Safety Research Center.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Source:
      Publisher: Korean Academy of Medical Science Country of Publication: Korea (South) NLM ID: 8703518 Publication Model: Electronic Cited Medium: Internet ISSN: 1598-6357 (Electronic) Linking ISSN: 10118934 NLM ISO Abbreviation: J Korean Med Sci Subsets: MEDLINE
    • Publication Information:
      Original Publication: Seoul, Korea : Korean Academy of Medical Science, [1986-
    • Subject Terms:
      COVID-19 Vaccines*/adverse effects ; COVID-19*/prevention & control ; COVID-19*/epidemiology ; SARS-CoV-2*/immunology; Humans ; Republic of Korea/epidemiology ; Causality ; United States
    • Abstract:
      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.
      Competing Interests: The authors have no potential conflicts of interest to disclose.
      (© 2024 The Korean Academy of Medical Sciences.)
    • References:
      Proc R Soc Med. 1965 May;58:295-300. (PMID: 14283879)
      J R Soc Med. 2009 May;102(5):186-94. (PMID: 19417051)
      Osong Public Health Res Perspect. 2023 Feb;14(1):5-14. (PMID: 36944340)
    • Grant Information:
      KDCA
    • Contributed Indexing:
      Keywords: Adverse Events; COVID-19 Vaccine Safety Research Center; COVID-19 Vaccines; Causality; National Academy of Medicine of Korea
    • Accession Number:
      0 (COVID-19 Vaccines)
    • Publication Date:
      Date Created: 20240709 Date Completed: 20240709 Latest Revision: 20240714
    • Publication Date:
      20240715
    • Accession Number:
      PMC11231440
    • Accession Number:
      10.3346/jkms.2024.39.e220
    • Accession Number:
      38978490