SAFETY-VAC: a framework for the post-authorisation safety monitoring and evaluation of vaccines in the European Union (SAFETY-VAC)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Feasibility analysis
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Electronic health records or registries data of people from 10 data sources in 7 countries in Europe from January 1st, 2017, till the last data availability were selected. Persons were included in the dynamic study population when they had: ; - Information on age and gender available, ; - At least one day of follow in the study period (1/1/2017- latest availability). ; Follow-up started at the latest date of any of the following dates: day that one year of lookback is available during the study period, or at 1/1/2017 when the person is born in the data base. ; Follow-up finished at the earliest of the following dates: death, disenrollment, end of study period, or recommended end date. For calculation of incidence rates of outcomes, occurrence of the diagnosis of interest for the selected events was an additional censoring date.
• Age groups:
  Paediatric Population (< 18 years)

  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  Retrospective multi-database population-based cohort study designed during the study period from January 1st, 2017, till the last data availability, with the aim of describing and assessing the fitness for purpose of data sources to address potential future studies on vaccine safety.
• Main study objective:
  This study specifically aims to provide and describe a network of real-world data sources for the evaluation of vaccine safety signals, and to assess its fitness-for-purpose through the following specific objectives: ; - To assess data quality for conducting safety studies on the general population, specific vaccines, and selected outcomes. ; - To assess whether data are fit-for-purpose for conducting future safety studies on specific vaccines and selected outcomes in a near real-time monitoring manner.
• Setting:
  In this study a multi-database cohort has been conducted using electronic health records or registries data from 10 data sources in 7 countries in Europe (UK, Spain, Denmark, Finland, Norway, Italy and France) from January 1st, 2017, till the last data availability. Persons were included in the dynamic study population when they had: ; - Information on age and gender available, ; - At least one day of follow in the study period (1/1/2017- latest availability).
• Outcomes:
  Thirty-nine events have been selected with EMA to assess data sources preparedness and estimate diseases’ incidence/prevalence rates. Clinical definition forms and codes’ lists including ICD9, ICD10, SNOMED, and ICPC codes have been generated using the standardized VAC4EU process for identifying the events. The list of events included: ; 1. Microangiopathy ; 2. Acute coronary artery disease ; 3. Arrhythmia ; 4. Myocarditis ; 5. Pericarditis ; 6. VTE (DVT & PE & Splanchnic) ; 7. Arterial thrombosis (AMI /Ischemic stroke) ; 8. TTS (VTE, arterial thrombosis, or CVST with thrombocytopenia in 10 days) ; 9. Pulmonary embolism ; 10. Haemorrhagic stroke ; 11. DIC (disseminated intravascular coagulation) ; 12. CVST ; 13. Generalised convulsion ; 14. Guillain Barré Syndrome ; 15. Diabetes (type 1) ; 16. Single organ cutaneous vasculitis ; 17. Erythema multiforme ; 18. Meningoencephalitis ; 19. Acute disseminated encephalomyelitis (ADEM) ; 20. Narcolepsy ; 21. Thrombocytopenia ; 22. Transverse myelitis ; 23. Bells’ palsy ; 24. Kawasaki's disease ; 25. Pancreatitis ; 26. Rhabdomyolysis ; 27. SCARs ; 28. Sensorineural hearing loss ; 29. Graves' disease ; 30. Hashimoto's thyroiditis ; 31. Auto-immune hepatitis ; 32. Polyarteritis nodosa ; 33. Rheumatoid arthritis ; 34. Psoriatic arthropathies ; 35. Systemic lupus erythematosus ; 36. Idiopathic thrombocytopenic purpura ; 37. Erythema nodosum ; 38. Multiple sclerosis ; 39. Ulcerative colitis