Incidence rates of pemphigus and pemphigoid following COVID-19 vaccines

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50716
• EU PAS number:
  EUPAS50715
• Study ID:
  50716
• Official title and acronym:
  Incidence rates of pemphigus and pemphigoid following COVID-19 vaccines
• DARWIN EU® study:
  No
• Study countries:
  Spain

  United Kingdom
• Study description:
  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. The study population is the general population in the UK and patients visiting general practices in Spain. As an exploratory analysis a Self-controlled Case Series design is applied
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 05/12/2022

Actual: 05/12/2022

Study start date

Planned: 05/12/2022

Actual: 05/12/2022

Date of final study report

Planned: 20/02/2023

Actual: 07/03/2023

Sources of funding

EMA

Study protocol

Initial protocol

FINAL_Analysis Plan - COVID-19 vaccines and pemphigoid - for publication

Regulatory

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