Study identification

PURI

https://redirect.ema.europa.eu/resource/46939

EU PAS number

EUPAS41623

Study ID

46939

Official title and acronym

Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine

DARWIN EU® study

No

Study countries

Italy
Netherlands
Norway
Spain
United Kingdom

Study description

A retrospective cohort design will be used to estimate the incidence of adverse events of special interest (AESI) after receiving the Pfizer-BioNTech COVID-19 vaccine doses and compare this incidence with that occurring in an unvaccinated comparator group matched on relevant individual characteristics (eg, age, comorbidities). Where appropriate, the study will also use a self-controlled risk interval (SCRI) design. The source population will comprise all individuals registered in each of the healthcare data sources who are eligible to receive the Pfizer-BioNTech COVID-19 vaccine. The study period will start on the date of launch of the Pfizer-BioNTech COVID-19 vaccine and will end on the date of the latest data availability or 31 Dec 2023. It is expected that follow-up will last for 2 years for AESI. People who are pregnant at time of vaccination or who become pregnant within two years of study start and their live born infants will be followed for an additional 12 months to collect information about birth outcomes and linked infant outcomes. Exposure will be based on recorded prescription, dispensing, or administration of the Pfizer-BioNTech COVID-19 vaccine. Vaccine administration and date of vaccination should be obtained from all possible sources that capture COVID-19 vaccination. The outcomes will be based on the AESI proposed by the European Medicines Agency sponsored ACCESS project (vACcine COVID-19 monitoring readinESS). AESI will be identified based on patient profile review of electronic records by healthcare professionals. In addition, manual review of patient charts conducted by clinicians blinded to COVID-19 vaccine exposure will be performed. Confirmation of an event diagnosis will be classified against existing definitions of the Brighton Collaboration and those currently being developed. The study will be performed within select data sources from Netherlands, Italy, Spain, United Kingdom, and Norway.

Study status

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Teamit Institute S.L., Fondazione Penta ONLUS

Networks

Contact details

Katie Kendrick

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Study protocol
Initial protocol

C4591021_PROTOCOL_20MAY2021____

English (844.83 KB - PDF)View document
Updated protocol

C4591021_PROTOCOL AMENDMENT 4_V6.0_18OCT2023

English (1.06 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)