DARWIN EU - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe – supporting international preparedness

04/05/2026
04/05/2026
EU PAS number:
EUPAS1000000969
Study
Ongoing
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Study summary
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Study identification

EU PAS number

EUPAS1000000969

Study ID

1000000969

Official title and acronym

DARWIN EU - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe – supporting international preparedness

DARWIN EU® study

Yes

Study countries

Denmark
Finland
Germany
Netherlands
Norway
Spain
Sweden
United Kingdom

Study description

The Coronavirus disease 2019 (COVID-19) pandemic highlighted the regulatory and public health need for timely post-authorisation safety monitoring of vaccines based on novel platforms (such as mRNA technology), but also for continuous monitoring throughout the lifecycle of established vaccines. Rapid regulatory response to vaccine safety concerns is crucial for maintaining public confidence. Information on background incidence rates of adverse events of special interest (AESIs) can support this response when used for rapid assessment via observed-to-expected analyses, an essential first step to inform further signal management. While evidence from real-world data (RWD) studies has been published during and after the pandemic, background rates vary across countries, data sources, with variable granularity/stratification in terms of population groups and important factors such as seasonality, therefore, updated evidence is needed to support preparedness and regulatory decision-making.
The International Coalition of Medicines Regulatory Authorities (ICMRA) Working Group on Real-World Evidence for Public Health Emergencies was established to provide a collaborative forum for international regulatory agencies to proactively enhance the efficiency and coordination of critical responses to emerging public health emergencies (PHEs) through joint evidence generation. This study aims to support a proof-of-concept within the Working Group, with the goal to generate evidence on background rates of eight vaccine AESIs selected based on capacity and interest at national level. Parallel studies will be conducted by other jurisdictions in collaboration with local research teams.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ivan Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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