Myocarditis and Pericarditis Associated with SARS-CoV-2 Vaccines in Four European Countries Using Large Electronic Health Care Data Sources: A Population-based Descriptive Cohort and a Nested Self-controlled Risk Interval Study

Sunday, August 28, 2022

1:45 PM – 2:00 PM CEST

Location: C1M5

Publication Number: 248

Background: The mRNA-based COVID-19 vaccines may elevate the risk of myo- and pericarditis, especially in young people. Although this is included in the product information of some of these vaccines, data from Europe are scarce and inconsistent about vaccine and dose-specific effects.

Objectives: To report absolute and relative incidence rates (IRs) of myo-/pericarditis before and after COVID-19 disease, and after each dose of four EMA-approved COVID-19 vaccines.

Methods: We combined primary and secondary healthcare data from Italy, the Netherlands, the United Kingdom, and Spain using a common data model. All individuals with complete data in 2020 were included from 1 January to 31 August 2021, end of data availability, or first myo- or pericarditis diagnosis. We calculated IRs before and after exposure to COVID-19 disease and after each vaccine dose. A nested self-controlled risk interval (SCRI) study including only vaccinated cases was performed to calculate IR ratios based on a 60-day control period prior to vaccination and dose-specific 28-day risk window. This design adjusts for all time-fixed confounders.

Results: The cohort comprised 25,720,158 individuals (49% women) aged 46 years, of which 47% received one vaccine dose and 27% two. The SCRI included 948 myo-/pericarditis cases. Myocarditis IRs were similar between young (12-29 years) and old (>30 years) individuals (3.6 vs 3.4 per 100,000 person-years, respectively), whereas pericarditis IRs were lower in the younger group (9.1 vs 14.2, respectively). Both myo- and pericarditis IRs increased twofold after COVID-19 disease except for myocarditis in the older group. Myo-/pericarditis IRs were also increased in the 28 days following the second Pfizer dose, which was confirmed in the SCRI (IRR=2.64, 95%CI 1.09-6.44). A similar trend was observed for Moderna, but there were insufficient individuals with a second dose of this vaccine to allow for valid analysis. Analyses in updated data instances with more vaccinated individuals are ongoing.

Conclusions: Incidence of myo-/pericarditis was increased after COVID-19 disease in all age groups and after the second Pfizer dose in those aged 12-29 years. Although a similar trend was seen for Moderna, data was too limited to draw any conclusions. Continued assessment of vaccine-associated myo-/pericarditis risk is needed, especially after the second dose.

Presenting Author(s)

Judit Riera Arnau, Dr

University Medical Center Utrecht
Barcelona, Barcelona, Spain

Slides

Co-Author(s)

Sophie H. Bots

Utrecht University
Utrecht University
Utrecht, Utrecht, Netherlands
Anna Schultze

London School of Hygiene and Tropical Medicine
London, United Kingdom
DM

Davide Messina

Agenzia Regionale di Sanita’, Florence Toscana, Italy, Italy
SB

Svetlana Belitser

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands, Netherlands
CD

Carlos Duran

Julius Center for Health Sciences and Primary Care, Department of Data Science & Biostatistics, University Medical Center Utrecht, the Netherlands, Netherlands
EA

Ema Alsina

Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands, Netherlands
ID

Ian Douglas, PhD

Professor
Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom
PG

Patricia García-Poza

AEMPS (Spanish Agency of Medicines and Medical Devices), Spain
Rosa Gini, PhD

Head of Department at Regional Health Agency of Tuscany, Florence, Italy
ARS Toscana, Florence, Italy
Florence, Toscana, Italy
RH

Ron Herings, PharmD, PhD, FISPE

Director
PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands
Utrecht, Utrecht, Netherlands
CH

Consuelo Huerta

Assistant Professor Epidemiology and Public Health
Faculty of Medicine. Department of Public Health. Complutense University of Madrid, Spain
MM

Mar Martin-Perez

AEMPS, Spain
IM

Ivonne Martin

Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands, Netherlands
Jetty Overbeek

PHARMO Institute
Utrecht, Utrecht, Netherlands
OP

Olga Paoletti

ARS Toscana, Florence, Italy, Italy
Patrick Souverein

Utrecht University, Netherlands
KS

Karin Swart

PHARMO Institute
Utrecht, Utrecht, Netherlands
Olaf H. Klungel, PharmD, PhD

Professor
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Utrecht, Netherlands
Miriam C. Sturkenboom, PharmD, PhD, FISPE

prof. dr.
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands