Validation of the newly proposed Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis

Vaccine. 2024 Nov 14;42(25):126131. doi: 10.1016/j.vaccine.2024.07.032. Epub 2024 Jul 12.

Abstract

Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a newly recognized syndrome mediated by anti-platelet factor 4 antibodies induced by Covid-19 adenovirus-vectored vaccines including ChAdOx1 nCoV-19 and Ad26.COV2.S. This study validated a proposed Brighton Collaboration case definition for VITT. A data collection form was developed and used to capture the variations in VITT criteria and assess their level of diagnostic certainty from adjudicated positive VITT case datasheets in Germany (n = 71), UK (n = 220), Australia (n = 203), and Taiwan (n = 56). We observed high prevalence of each component of the proposed VITT definition in positive cases (84%-100%), except for the occurrence of thrombosis or thromboembolism criterion in only 34% of VITT cases in Taiwan. The sensitivity of this proposed definition was 100% for Germany and UK, 92% for Australia, and 89% for Taiwan cases. These findings support the validity of this case definition for VITT.

Keywords: Adverse event; Case definition; Immunization; VITT; Vaccine-induced immune thrombocytopenia and thrombosis; Validation.

Publication types

  • Validation Study

MeSH terms

  • Ad26COVS1 / adverse effects
  • Adult
  • Aged
  • Australia / epidemiology
  • COVID-19 / diagnosis
  • COVID-19 / immunology
  • COVID-19 / prevention & control
  • COVID-19 Vaccines* / adverse effects
  • COVID-19 Vaccines* / immunology
  • ChAdOx1 nCoV-19* / adverse effects
  • ChAdOx1 nCoV-19* / immunology
  • Female
  • Germany / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Platelet Factor 4 / immunology
  • Purpura, Thrombocytopenic, Idiopathic* / chemically induced
  • Purpura, Thrombocytopenic, Idiopathic* / diagnosis
  • Purpura, Thrombocytopenic, Idiopathic* / epidemiology
  • Purpura, Thrombocytopenic, Idiopathic* / etiology
  • Purpura, Thrombocytopenic, Idiopathic* / immunology
  • SARS-CoV-2 / immunology
  • Taiwan / epidemiology
  • Thrombosis* / etiology
  • Thrombosis* / immunology
  • United Kingdom / epidemiology

Substances

  • COVID-19 Vaccines
  • ChAdOx1 nCoV-19
  • Ad26COVS1
  • Platelet Factor 4