Study identification

PURI

https://redirect.ema.europa.eu/resource/107616

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 institution and networks

Networks

Contact details

Annika Jodicke

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN_EU_D2.2.3_Protocol_P2-C3-002_V2.1_Public.pdf

English (1.24 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable