Status: Ongoing First registered on: 25/06/2021
Last updated on: 28/04/2022
1. Study identification
EU PAS Register NumberEUPAS41623
Official titlePost Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Study title acronym
Study typeObservational study
Brief description of the studyA 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 (e.g., 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 health care 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 health care 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.
Was this study requested by a regulator?No
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

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 signed15/12/202015/12/2020
Start date of data collection30/09/202103/09/2021
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 1235 East 42nd Street
Address line 2Mail Stop 219/8/01 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States
Phone number (incl. country code)12127338491 
Alternative phone number18454743186 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name de Luise 
First name Cynthia 
Address line 1235 East 42nd Street 
Address line 2Mail Stop 219/8/01 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States 
Phone number (incl. country code)12127338491 
Alternative phone number18454743186 
Fax number (incl. country code) 
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