New study of VAERS data has found that 37% of the reported myocarditis/pericarditis following the COVID Vaccine were under the age of 25. “Approximately 37.6% of the total reported myo/pericarditis cases following vaccination were under the age of 25.” “Males comprised the majority of reported cases (66.1%), and females accounted for (31.6%) of the reports, with missing data on sex in the remaining (2.29%) reports.” Of the COVID vaccines Pfizer/BioNTech had the highest number of myo/pericarditis reports at (60.6%), followed by Moderna with myo/pericarditis reports of (33.7%) and Janssen with myo/pericarditis reports of (4%).
Published: 28 July 2023
Article
Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective
Abdallah Alami 1,2,*, Paul J. Villeneuve 3 , Patrick J. Farrell 1, Donald Mattison 4,5,6, Nawal Farhat 1 ,
Nisrine Haddad 4, Kumanan Wilson 7,8,9, Christopher A. Gravel 4,10,11, James A. G. Crispo 12,13,
Santiago Perez-Lloret 14,15,16 and Daniel Krewski 2,4,5
1 School of Mathematics and Statistics, Carleton University, Ottawa, ON K1S 5B6, Canada;
nfarh033@uottawa.ca (N.F.)
2 McLaughlin Centre for Population Health Risk Assessment, University of Ottawa,
Ottawa, ON K1N 6N5, Canada
3 Department of Neuroscience, Faculty of Science, Carleton University, Ottawa, ON K1S 5B6, Canada
4 School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada
5 Risk Sciences International, Ottawa, ON K1P 5J6, Canada
6 Arnold School of Public Health, University of South Carolina, Columbia, SC 29208, USA
7 Department of Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada
8 Bruyère Research Institute, Ottawa, ON K1R 6M1, Canada
9 Ottawa Hospital Research Institute, Ottawa, ON K1Y 4E9, Canada
10 Department of Epidemiology, Biostatistics and Occupational Health, McGill University,
Montreal, QC H3A 1Y7, Canada
11 Department of Mathematics and Statistics, University of Ottawa, Ottawa, ON K1N 6N5, Canada
12 Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC V6T 1Z3, Canada
13 Division of Human Sciences, NOSM University, Sudbury, ON P3E2C6, Canada
14 Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires C1033AAJ, Argentina
15 Observatorio de Salud Pública, Pontificia Universidad Católica Argentina,
Buenos Aires C1107AAZ, Argentina
16 Department of Physiology, Faculty of Medicine, University of Buenos Aires,
Buenos Aires C1121ABG, Argentina
* Correspondence: abdallahalami@cmail.carelton.ca
Abstract: Concerns remain regarding the rare
cardiovascular adverse events, myocarditis and peri-carditis
(myo/pericarditis), particularly in younger individuals following mRNA COVID-19
vaccination. Our study aimed to comprehensively assess potential safety signals
related to these cardiac events following the primary and booster doses, with a
specific focus on younger populations,including children as young as 6 months
of age. Using the Vaccine Adverse Events ReportingSystem (VAERS), the United
States national passive surveillance system, we conducted a retrospective pharmacovigilance study analyzing spontaneous reports of myo/pericarditis.
We employedboth frequentist and Bayesian methods and conducted subgroup
analyses by age, sex, and vaccinedose. We observed a higher reporting rate of
myo/pericarditis following the primary vaccine series,particularly in males and
mainly after the second dose. However, booster doses demonstrated a lower
number of reported cases, with no significant signals detected after the fourth
or fifth doses.In children and young adults, we observed notable age and sex
differences in the reporting ofmyo/pericarditis cases. Males in the 12–17 and
18–24-year-old age groups had the highest number ofcases, with significant
signals for both males and females after the second dose. We also identifiedan
increased reporting for a spectrum of cardiovascular symptoms such as chest
pain and dyspnea,which increased with age, and were reported more frequently
than myo/pericarditis. The present study identified signals of myo/pericarditis
and related cardiovascular symptoms after Mrna COVID-19 vaccination, especially
among children and adolescents. These findings underline theimportance for
continued vaccine surveillance and the need for further studies to confirm
theseresults and to determine their clinical implications in public health
decision-making, especially for
younger populations.
5. Conclusions
In summary, our study sheds light on the potential risk of myo/pericarditis
following a mRNA COVID-19 vaccination in younger populations, highlighting the need
for the on-going monitoring and evaluation of this rare adverse event. The
use of a disproportionality analysis utilizing both frequentist and Bayesian
methods generated pharmacovigilancesignals for the primary series doses, with
the strongest signal observed following the ad-ministration of the second dose.
Although a lower number of myo/pericarditis cases werereported for the booster
doses, evidence of related cardiovascular symptoms post-mRNAimmunization was
detected in younger populations and warrants further study. Whileour study is
subject to the potential limitations inherent in self-reporting databases, itunderscores
the importance of ongoing vaccine safety surveillance and the need for a betterunderstanding
of the risks and benefits of COVID-19 vaccines in younger populations.It is
important to note that the reporting relationships flagged by the signal
detectionapproaches do not imply causal associations and require confirmation
through follow-upresearch, including analytic epidemiological studies, such as
those based on electronichealth records. Nevertheless, statistical signal
detection provides a quick and efficient way to generate hypotheses and to
explore potential risks within specific age groups, sexes, timeframes, and
product types, thereby providing early warnings of potential safety concerns.
Pfizer's study of myocarditis for those who received its Covid booster is now officially under the status "delayed" in FDA website 👇
— Dr. Eli David (@DrEliDavid) July 29, 2023
The study was supposed to complete by the end of 2022. What have they found in the study that they're hiding? 🧐
We all know the answer… pic.twitter.com/Ri0OGlPsL4
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