(A-339) 2024 interim results from the VAC4EU post-authorisation safety study (PASS) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Europe

Sunday, August 24, 2025

12:00 PM - 1:30 PM ET

Presenting Author(s)

DW

Daniel Weibel

Vaccine monitoring collaboration for Europe (VAC4EU), Brussels, Belgium, Netherlands

Co-Author(s)

Cd

Cynthia de Luise, PhD, MPH

Senior Director, Safety Surveillance Research
Pfizer Pharmaceuticals, United States
AC

Albert Cid Royo

Department of Data Science and Biostatistics, Julius Center for Health Science and Primary Care, University Medical Center of Utrecht, Utrecht University, Utrecht, The Netherlands, Netherlands
OR

Oisin Ryan

Assistant Professor, University Medical Center Utrecht, Utrecht, the Netherlands, Netherlands
TV

Tiago Vaz

Assistant Professor, University Medical Center Utrecht, Netherlands
JA

Jaume Aguado

RTI Health Solutions, Barcelona, Spain, Spain
JM

Josep Marsal

RTI Health Solutions, Spain
Xabier García de Albéniz

RTI Health Solutions, Spain
RW

Rachel Weinrib

Research Epidemiologist
RTI Health Solutions, Barcelona, Spain, Spain
EP

Elena Palà, PhD

Teamit Institute, Spain
MH

Margaret Haugh

UMC Utrecht, France
BP

Beatriz Poblador

EpiChron Research Group, Aragon Health Sciences Institute (IACS), Miguel Servet University Hospital, Zaragoza, Spain, Spain
AG

Antonio Gimeno-Miguel

EpiChron Research Group, Aragon Health Sciences Institute (IACS), Miguel Servet University Hospital, Zaragoza, Spain, Spain
AS

Alejandro Santos-Mejías

EpiChron Research Group, IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain, Spain
EM

Ettore Marconi

Health Search, Italy
EB

Elisa Barbieri, PharmD

Post-Doc Researcher, Department for Women’s and Children’s Health, University of Padova, Italy
LS

Luca Stona

Fondazione Penta ETS, Italy
TL

Thom Lysen

PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands, Netherlands
JG

Jordy Gaspersz

PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands, Netherlands
JO

Jetty Overbeek

PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands, Netherlands
RH

Ron Herings

PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands, Netherlands
DR

Debabrata Roy

Drug Safety Research Unit (DSRU), Southampton, UK, United Kingdom
SL

Samantha Lane

Drug Safety Research Unit, Southampton, UK, United Kingdom
CF

Catherine Fry

Drug Safety Research Unit, Southampton, UK, United Kingdom
DM

Denise Morris

Drug Safety Research Unit, Southampton, UK, United Kingdom
GH

Giulia Hyeraci

Agenzia Regionale di Sanità della Toscana (ARS Toscana), Florence, Italy, Italy
AG

Anna Girardi

Agenzia Regionale di Sanità della Toscana (ARS Toscana), Florence, Italy, Italy
AL

Angela Lupattelli

Professor
Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway
AD

Anteneh Desalegn

Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway
Felipe Villalobos

Primary care researcher
Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Spain
CB

Carlo Alberto Bissacco

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Spain
HR

Heather Rubino

Pfizer Inc, United States
MS

Miriam C.J. Sturkenboom

Department of Data Science and Biostatistics, Julius Center for Health Science and Primary Care, University Medical Center of Utrecht, Utrecht University, Utrecht, The Netherlands, Netherlands
Alejandro Arana, MD, MPH, MSc, FISPE

Senior Director, Epidemiology
RTI Health Solutions, Barcelona, Spain
Barcelona, Spain

Background: Comirnaty® received conditional marketing authorisation in the European Union (EU), United Kingdom (UK) and United States (US) in December 2020. We describe interim results from a post-authorisation safety study (PASS); a commitment to EU and US regulatory authorities.

Objectives: Determine the risk of 37 adverse events of special interest (AESIs) following ≥1 dose of Comirnaty in the general European population.

Methods: This is an ongoing retrospective cohort study, with Comirnaty vaccinated and unvaccinated matched 1:1 on age, sex and other demographic and clinical factors, from 6 electronic health record data sources in 5 countries: Italy (Pedianet, general practitioner, GP); Netherlands (PHARMO Data Network, GP); Norway (NHR, inpatient and outpatient); Spain (EpiChron, GP and inpatient and SIDIAP, GP and inpatient/outpatient specialist); and UK (CPRD Aurum, GP). Analyses were conducted using a common protocol, the ConcePTION common data model and common analytical programs. Propensity score-adjusted hazard ratios (HRs) were estimated for event-specific risk windows.

Results: From December 2020 to March 2022 (CPRD Aurum), December 2022 (Pedianet, NHR), June 2023 (PHARMO, SIDIAP) and July 2023 (EpiChron), 12,400,847 recipients of ≥1 dose of Comirnaty were matched (Pedianet: 10,500, NHR: 3,584,238, PHARMO: 992,144, EpiChron: 627,972, SIDIAP: 3,087,124, CPRD: 4,098,869).

There was no increased risk of most of the 37 AESIs associated with the vaccine, including myocarditis (21-day risk window) with HRs of 0.94 (95% CI: 0.46, 1.94) in NHR, 1.23 (95% CI: 0.13, 11.84) in PHARMO, 3.64 (95% CI: 0.41, 32.53) in EpiChron, 1.05 (95% CI: 0.35, 3.16) in SIDIAP, and 2.30 (95% CI: 0.94, 5.66) in CPRD. Results of note were arrhythmia with HRs of 1.36 (95% confidence interval [CI]: 1.29, 1.44) in PHARMO, 1.03 (95% CI: 1.00, 1.05) in NHR, 1.12 (95% CI: 1.04, 1.21) in EpiChron, and 1.27 (95% CI: 1.21, 1.33) in CPRD; heart failure 1.29 (95% CI: 1.13, 1.47) in PHARMO; coronary artery disease 1.49 (95% CI: 1.31, 1.69) in PHARMO, and 1.40 (95% CI: 1.30, 1.50) in CPRD. For secondary amenorrhoea, HRs were 1.71 (95% CI: 1.34, 2.18) in EpiChron and 1.24 (95% CI: 1.17, 1.30) in CPRD and for hypermenorrhoea 1.40 (95% CI: 1.23, 1.60) in EpiChron.

Conclusions: In this PASS which evaluated the safety of Comirnaty for 37 AESIs in >12 million vaccinated individuals, there was no increased risk for most AESIs. However, adjusted HRs for a few cardiac events and menstrual disorders were slightly elevated among vaccinated in some data sources. Potential explanations for these results include the divergence of cumulative incidence of cardiac events with long risk windows and differences in the composition of unvaccinated individuals over time.