Study identification

PURI

https://redirect.ema.europa.eu/resource/47709

EU PAS number

EUPAS47708

Study ID

47709

Official title and acronym

Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis 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

This study will address the following research question, “What is the clinical course of myocarditis and pericarditis cases after being vaccinated with the Pfizer-BioNTech COVID-19 vaccine in European countries?”.

This cohort study is nested in the ongoing retrospective cohort study (EUPAS41623) titled "Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine." The parent study includes individuals across 5 European countries who receive at least 1 dose of the Pfizer-BioNTech COVID-19 vaccine, as well as individuals who did not receive a COVID-19 vaccine. For the primary objective (natural history), the study will be conducted in the cohort of cases of myocarditis and of pericarditis identified in the full population of the parent study. For the secondary objective (risk factors), the study will be conducted using the population from the parent study component in which vaccinated and unvaccinated individuals are matched 1:1 on date of vaccination in the vaccinated group and date of study eligibility in the unvaccinated group. Individuals are also matched on age, sex, history of COVID-19, place of residence, history of influenza vaccination, pregnancy status, immunocompromised status, presence of pre-existing medical conditions, and socioeconomic status/education level. The matching variables, vaccination status, and other baseline variables to be identified in a review of the medical literature will be considered as potential risk factors for the development of myocarditis and of pericarditis.

Study status

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Teamit Institute
Spain
First published:
12/03/2024
Institution
OtherENCePP partner
Fondazione Penta ONLUS

Networks

Contact details

Cynthia de Luise

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

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

C4591038_PROTOCOL AMENDMENT 2_V3_13MAY2022

English (4.52 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)