Status: Ongoing First registered on: 22/08/2022
Last updated on: 07/08/2023
1. Study identification
EU PAS Register NumberEUPAS47708
Official titlePost-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Study title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre namePfizer
Centre locationUnited States
Details of (Primary) lead investigator
Title Dr
Last name de Luise
First name Cynthia
Is this study being carried out with the collaboration of a research network?
Yes

VAC4EU
RTI Health Solutions
Teamit Institute S.L.
Fondazione Penta ONLUS
University Medical Center Utrecht
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Italy
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/10/202127/10/2021
Start date of data collection31/12/202210/02/2023
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name de Luise
First name Cynthia
Address line 166 Hudson Boulevard
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States
Phone number (incl. country code)12127338491 
Alternative phone number 
Fax number (incl. country code) 
Email address cynthia.deluise@pfizer.com
Public Enquiries
Title Dr 
Last name de Luise 
First name Cynthia 
Address line 166 Hudson Boulevard 
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States 
Phone number (incl. country code)12127338491 
Alternative phone number 
Fax number (incl. country code) 
Email address cynthia.deluise@pfizer.com 
Top