Incidence rates of vulval ulceration following Comirnaty vaccine

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

• Study drug International non-proprietary name (INN) or common name:
  TOZINAMERAN
• Medical condition to be studied:
  Vulval ulceration

Population studied

• Short description of the study population:
  The study focused on general population in UK and patients visiting general practices in Spain identified through IMRD and THIN databases to determine the incidence rates of vulval ulceration and vulval ulceration in the vaccine exposed population.
• Age groups:
  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)

  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with vulval ulceration
• Estimated number of subjects:
  880000

Study design details

• Main study objective:
  To describe - Comirnaty vaccine exposure stratified by age, no of doses, and year of vaccination. - Incidence rates of vulval ulceration (i) in the general population stratified by age and year, (ii) following exposure to Comirnaty vaccine stratified by age, no of doses and year, and (iii) following exposure to other COVID-19 vaccines stratified by age, no of doses and year
• Outcomes:
  Vulval ulceration, Vaccine utilisation was stratified by age group and number of doses. Event rates for vulval ulceration in the general population were stratified by age group and year. Event rates among exposed patients were stratified by age, and number of doses. Age was categorised as: < 10; 10-19; 20-29; 30-39; 40-49; 50-59; 60-69; 70-79; ≥80 years.
• Data analysis plan:
  This was a cohort study describing vaccine exposure, population incidence rates of vulval ulceration and incidence rates of vulval ulceration in the vaccine exposed population (incl an exploratory Self-controlled Case Series)

Documents

Study results

FINAL_report_Comirnaty and vulval ulceration_Nov2022_for_publication (1)