Incidence rates of pemphigus and pemphigoid following COVID-19 vaccines

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine:
  COMIRNATY

  SPIKEVAX

  VAXZEVRIA
• Study drug International non-proprietary name (INN) or common name:
  ELASOMERAN

  TOZINAMERAN

  COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)
• Medical condition to be studied:
  Pemphigoid

  Pemphigus

Population studied

• Short description of the study population:
  The study focused on general population in the UK and patients visiting general practices in Spain identified through the IQVIA™ Medical Research Data (IMRD) and THIN® databases.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • 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)
• Estimated number of subjects:
  3200000

Study design details

• Main study objective:
  This study aims to describe Comirnaty, Spikevax and Vaxzevria vaccine exposure, incidence rates of new onset pemphigus or pemphigoid (or related conditions) in the general population and following exposure to Comirnaty, Spikevax or Vaxzevria vaccines. A Self-controlled Case Series is conducted as an exploratory analysis.
• Outcomes:
  Pemphigoid and pemphigus, Vaccine utilisation will be stratified by sex, age (at first use), and year of vaccination. Event rates for pemphigoid and pemphigus in the general population will be stratified by sex, age and year of recorded diagnosis. Event rates among exposed patients will be stratified by number of doses
• Data analysis plan:
  This is a cohort study describing vaccine exposure, population incidence rates of pemphigus and pemphigoid, and incidence rates of pemphigus and pemphigoid in the vaccine exposed population. A Self-controlled Case Series is conducted as an exploratory analysis.