ASSOCIATION BETWEEN THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) OR THROMBOEMBOLIC EVENTS, AND COVID-19 VACCINES

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX) Other viral vaccines

  Other viral vaccines
• Medical condition to be studied:
  Thrombosis with thrombocytopenia syndrome

  Venous thrombosis

Population studied

• Short description of the study population:
  All adult persons (aged >=18 at the index date) registered in any of the contributing databases within the study period and with at least one year of database history before the index date will be included in the target population.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  80000000

Study design details

• Main study objective:
  1) To study the association between COVID-19 vaccine and thrombosis with thrombocytopenia syndrome/s (TTS) and thromboembolic events (VTE) 2) To quantify the association betweendifferent COVID-19 vaccine brands and the occurrence of TTS /VTE 3) To study the association between pre-specified risk factors and the occurrence of VTE/TTS 4) To characterize treatments used after post-vaccine VTE/TTS
• Outcomes:
  VTE thrombosis with thrombocytopenia syndrome
• Data analysis plan:
  characters The study period will cover from Dec 2020 (first vaccine users) until the latest data release available in each of the contributing databases. For objective 1a-2b, we will use propensity-score-matching to select comparable people in each two cohorts. We will report incidence rates of TTS or TE in the 14, 21 and 28 days following the index date in each PS matched cohort. Incidence Rate ratio (IRR) will be used to quantify the risk of developing TTS (Objective 1) or TE (Objective 2) via Poisson models. RRs will be stratified by 10-year age bands, sex, and vaccine type/brand (only for Objective 1a and 2a). Logistic regression will be used to identify risk factors associated with TTS/VTE/ATE among people vaccinated against SARS-CoV-2.

Documents

Study results

Obj1and2_Report_approved

Study report

Obj3and4_Report_approved

Study publications

Junqing Xie, Albert Prats-Uribe, Maria Gordillo Maranon, Victoria Y. Strauss, …