Incidence rates of vulval ulceration following Comirnaty vaccine

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50610
• EU PAS number:
  EUPAS50609
• Study ID:
  50610
• Official title and acronym:
  Incidence rates of vulval ulceration following Comirnaty vaccine
• DARWIN EU® study:
  No
• Study countries:
  Spain

  United Kingdom
• Study description:
  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 (UK & Spain). An exploratory Self-controlled Case Series was also conducted (UK only). The study population was the general female population in the UK and female patients visiting general practices in Spain.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 26/09/2022

Actual: 26/09/2022

Study start date

Planned: 26/09/2022

Actual: 26/09/2022

Date of final study report

Planned: 29/11/2022

Actual: 29/11/2022

Sources of funding

EMA

Study protocol

Initial protocol

Analysis Plan - Comirnaty and vulval ulceration - Oct 2022 - for publication

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable