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Open AccessArticle

Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome

1
Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA
2
College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon 21983, Korea
3
Department of Pharmaceutical Medicine and Regulatory Sciences, Colleges of Medicine and Pharmacy, Yonsei University, Incheon 21983, Korea
4
College of Pharmacy, Chung-Ang University, Seoul 06974, Korea
5
Department of Biotechnology, College of Life Science and Biotechnology, Yonsei University, Seoul 03722, Korea
6
Department of Pediatrics, Yonsei University College of Medicine, Seoul 03722, Korea
*
Author to whom correspondence should be addressed.
The authors contributed equally.
Vaccines 2020, 8(1), 101; https://doi.org/10.3390/vaccines8010101
Received: 14 November 2019 / Revised: 19 December 2019 / Accepted: 20 February 2020 / Published: 24 February 2020
(This article belongs to the Special Issue Strategies Addressing Falling Vaccine Coverage and Vaccine Hesitancy)
South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a severe neurological disease with limb pain and muscle weakness as cardinal symptoms, is attracting attention as an AEFI. However, algorithm or guidelines for assessing the causality between vaccination and the incidence of GBS are lacking. We aimed to develop guidelines for causality assessment of GBS as an AEFI and suggest using these guidelines in alignment with the VICP. We systematically searched for other previously published algorithms or guidelines and found a WHO-AEFI guideline used worldwide; however, it only provides general instructions and is not tailored to specific adverse events. We translated and locally adapted the structure of this guideline and then added contents related to GBS. The GBS-specific guideline consists of four steps: case ascertainment of GBS, checklist (including (1) order of incidence, (2) temporal proximity, (3) evidence for other causes and (4) published evidence), an algorithm, and final classification. We listed key information on confirming GBS and whether any other causes of GBS were present. For real world application of the guideline along with the VICP, we collaborated with a panel of neurologists, epidemiologic investigators, and committee members from the VICP. To ensure transparency and a scientific approach, regular updates and collaboration with neurologists are essential. We expect that this guideline will contribute to logical causality assessment and compensation decisions for GBS and will provide the basic structure for causality assessment of other AEFIs. View Full-Text
Keywords: adverse event; causality assessment; guideline; Guillain–Barré syndrome; vaccine adverse event; causality assessment; guideline; Guillain–Barré syndrome; vaccine
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MDPI and ACS Style

Lee, H.; Kang, H.-Y.; Cho, S.; Park, S.; Kim, A.-Y.; Jung, S.-Y.; Seong, B.L.; Lee, Y.-M. Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome. Vaccines 2020, 8, 101. https://doi.org/10.3390/vaccines8010101

AMA Style

Lee H, Kang H-Y, Cho S, Park S, Kim A-Y, Jung S-Y, Seong BL, Lee Y-M. Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome. Vaccines. 2020; 8(1):101. https://doi.org/10.3390/vaccines8010101

Chicago/Turabian Style

Lee, Hankil; Kang, Hye-Young; Cho, Sunghwa; Park, Seonyoung; Kim, Ah-Young; Jung, Sun-Young; Seong, Baik L.; Lee, Young-Mock. 2020. "Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome" Vaccines 8, no. 1: 101. https://doi.org/10.3390/vaccines8010101

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