Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Coverage evaluation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective (multi)-database study

Population studied

• Short description of the study population:
  The study included all patients registered in the electronic medical record databases, claims databases or population-based immunizations registers that capture electronic information on the covid-19 vaccine.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  This is a template protocol to determine exposure and coverage to COVID-19 vaccines and to determine exposure and coverage to COVID-19 vaccines in specific subgroups that are targeted for vaccination.
• Data analysis plan:
  This protocol template includes a section describing descriptive analysis, measures of coverage, data integration, subroup analysis and sensitivity analysis as well as quality control.