Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness and the impact of COVID-19 vaccines through routinely collected exposure and outcome data using health registries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000101
• EU PAS number:
  EUPAS1000000101
• Study ID:
  1000000101
• Official title and acronym:
  Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness and the impact of COVID-19 vaccines through routinely collected exposure and outcome data using health registries
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Luxembourg

  Norway

  Portugal

  Spain
• Study description:
  A retrospective cohort was constructed from linked electronic health records (EHR) in each country. Country specific (level) relative VE (rVE) was estimated on a monthly basis, using a study period covering an eight-week follow-up period. Each month the study period was shifted forward to the following month. Country estimates were then pooled together. The study period covered in this report is April 2022 to March 2023. The rVE of first, second and third booster doses was estimated and compared to the VE of complete primary vaccination received at least 24 weeks ago (≥24 weeks).
• Study status:
  Ongoing

Research institutions and networks

Institutions

European Centre for Disease Prevention and Control

EpiConcept

Study timelines

Date when funding contract was signed

Actual: 19/10/2021

Study start date

Actual: 28/01/2022

Date of final study report

Planned: 31/10/2025

Sources of funding

Other

More details on funding

Funded by European Centre for Disease Prevention and Control

Study protocol

Protocol for a COVID-19 vaccine effectiveness estimation using health data registries, VEBIS multi-country study - Version 2.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable