Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)

01/04/2021
01/07/2024
EU PAS number:
EUPAS40404
Study
Finalised
Subscribe
Download as PDF
Study summary
No information provided.
Study identification

EU PAS number

EUPAS40404

Study ID

50430

Official title and acronym

Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain
United Kingdom (Northern Ireland)

Study description

This study will monitor AESI prior and following COVID-19 vaccination, with the purpose to estimate the incidence rates and pick up signals. This study will be conducted with funding from the EMA and in 4 data sources that have access to COVID-19 vaccine data and are able to rapidly update their data

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 6 centres are involved in the study

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
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