DARWIN EU® Effectiveness of COVID-19 vaccines on severe COVID-19 and post acute outcomes of SARS-CoV-2 infection

Study identification

• EU PAS number:
  EUPAS107615
• Study ID:
  107616
• Official title and acronym:
  DARWIN EU® Effectiveness of COVID-19 vaccines on severe COVID-19 and post acute outcomes of SARS-CoV-2 infection
• DARWIN EU® study:
  Yes
• Study countries:
  Netherlands

  Spain

  United Kingdom
• Study description:
  COVID 19 vaccines were authorised for use in the European Union, and these vaccines, and any future adapted vaccines, would therefore benefit from post authorisation studies to provide real world evidence to guide regulatory and vaccination policies. ; This study will aim to assess 1 the effectiveness and waning of effectiveness of COVID 19 vaccination for the prevention of severe COVID 19 related outcomes, 2 effectiveness of COVID 19 vaccination for the prevention of all cause mortality in the 3 and 6 months following discharge for COVID 19 related hospitalization as well as 3 effectiveness of COVID 19 vaccination for the prevention of post COVID 19 complications, namely of new onset type 1 Diabetes Mellitus, new onset type 2 Diabetes Mellitus, and cardiovascular events in the 12 months after a SARS CoV 2 infection.
• Study status:
  Finalised

Research institutions and networks

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:26/07/2023

Actual:26/07/2023

Study start date

Planned:01/01/2021

Actual:01/01/2021

Date of final study report

Planned:31/01/2023

Actual:01/07/2024

Sources of funding

EMA

Regulatory

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