Study identification

PURI

https://redirect.ema.europa.eu/resource/50433

EU PAS number

EUPAS42467

Study ID

50433

Official title and acronym

Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)

DARWIN EU® study

No

Study countries

Belgium
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

Readiness The readiness phase will include the following objectives: • To provide an overview of the methods for identification of COVID-19 vaccine exposure in the data sources • To monitor the number of individuals exposed to any COVID-19 vaccine and to compare this to COVID-19 vaccine exposure data • To quantitatively evaluate different algorithms to identify adverse events by provenance in electronic health care data • To conduct time-to-onset analyses for the AESI with respect to time since vaccination • To assess the association between and the vaccines of interest and negative control events using the SCRI to estimate systematic bias (unmeasured confounding) • To test the impact of different comparators in the cohort design, using the negative control outcomes • To generate information for testing of methodological questions around misclassification of events/exposure Rapid assessment studies Primary objective The primary objective for this rapid assessment study is to assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines within disease-specific risk periods in individuals exposed to the COVID-19 vaccines compared to other COVID-19 vaccine exposed individuals or compared to a control window within the same individual. Secondary objectives The secondary objectives for the rapid assessments studies are: • To assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines in the following subgroups o immunocompromised persons o persons with the presence of co-morbidities elevating the risk of serious COVID-19 o persons with a history of diagnosed COVID-19 disease o pregnant women o age groups o patients with a prior history (ever) of that event more than a year before. Study design: A retrospective, multi-database, self-controlled risk interval or cohort study

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profit
ENCePP partner
FISABIO Spain, University Oslo Norway

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol
English (1.41 MB - PDF)View document
Updated protocol
English (792.38 KB - 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