Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000254

EU PAS number

EUPAS1000000254

Study ID

1000000254

Official title and acronym

DARWIN EU® - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe

DARWIN EU® study

Yes

Study countries

Germany
Netherlands
Norway
Spain
United Kingdom

Study description

Vaccines are approved for immunisation against various infectious diseases, with an increasing number based on novel platforms like mRNA technology. Safety information for these new platforms was limited to pre-licensure clinical trials until the COVID-19 pandemic. The pandemic highlighted the need for timely post-authorisation vaccine safety surveillance for new vaccines and continuous monitoring throughout the lifecycle for established vaccines. Rapid regulatory responses to vaccine safety concerns are crucial for maintaining public confidence. Background incidence rates of adverse events of special interest (AESIs) can support these responses, with observed-to-expected analyses being essential for informing further signal evaluation.
The 2020 EMA-funded ACCESS project aimed to estimate the background rates of AESIs for monitoring COVID-19 vaccines. Several publications have contributed to global knowledge on background incidence rates, but regular updates are needed to remain prepared for new safety concerns. Granularity in estimates, particularly regarding risk groups and factors like seasonality, is important. Background rates vary across age groups, sex, regions, and data sources, influenced by different clinical coding systems and healthcare practices. Understanding patient demographics and clinical characteristics aids in evaluating potential safety signals. While some AESIs are specific to certain vaccines, others like Guillain-Barre syndrome are associated with various vaccines. This study aims to expand previous research on AESIs to support safety monitoring for both approved and newly developed vaccines. This study will support vaccine safety monitoring endeavours as part of the Vaccine Monitoring platform.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Xintong Li

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
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3_C3_001_AESI_V3.pdf

English (724.8 KB - PDF)View document
Updated protocol

DARWIN EU_Protocol_P3_C3_001_AESI_V4.pdf

English (725.73 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Unknown

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

Not applicable