Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
Open Access
- 24 February 2020
- Vol. 8 (1), 101
- https://doi.org/10.3390/vaccines8010101
Abstract
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.Funding Information
- Korea Centers for Disease Control and Prevention (2018-E2402-00)
This publication has 53 references indexed in Scilit:
- Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series StudyPLOS ONE, 2013
- The history of vaccination and current vaccination policies in KoreaClinical and Experimental Vaccine Research, 2012
- No-fault compensation following adverse events attributed to vaccination: a review of international programmesBulletin of the World Health Organization, 2011
- Population Incidence of Guillain-Barré Syndrome: A Systematic Review and Meta-AnalysisNeuroepidemiology, 2011
- Two Cases of Scrub Typhus Presenting with Guillain-Barré Syndrome with Respiratory FailureThe Korean Journal of Internal Medicine, 2011
- Antiganglioside antibodies and their pathophysiological effects on Guillain-Barre syndrome and related disorders--A reviewGlycobiology, 2009
- Guillain-Barré Syndrome and Preceding Infection with Campylobacter, Influenza and Epstein-Barr Virus in the General Practice Research DatabasePLOS ONE, 2007
- Guillain-Barr?? SyndromeDrugs, 2004
- Drug-Induced Stevens-Johnson Syndrome/Toxic Epidermal NecrolysisAmerican Journal of Clinical Dermatology, 2000
- Guillain-Barré syndrome in Plasmodium falciparum malariaHeart, 1992