Here's a report out of Canada, getting away from the U.S. Big Pharma influence.
https://www.publichealthontario.ca/-/media/documents/ncov/vaccines/2021/11/myocarditis-pericarditis-mrna-vaccines.pdf?sc_lang=en
Myocarditis and Pericarditis after COVID-19 mRNA Vaccines
November 2021
Key Messages
-A number of cases of myocarditis/pericarditis following immunization with mRNA COVID-19
vaccines have been reported in Ontario, Canada, and internationally. Reported cases have
occurred more frequently in males under the age of 30 years, commonly following their second
dose, usually within one week of vaccination, and have been mild with a quick recovery.
The observed number of cases of myocarditis/pericarditis following administration of a mRNA
vaccine is higher than expected in some jurisdictions, including Ontario, Canada, and the United
States (US). Preliminary post-marketing safety data reported in Canada and the US suggests
higher rates of myocarditis/pericarditis reported after Moderna Spikevax® compared to Pfizer-
BioNTech Comirnaty®.
-The National Advisory Committee on Immunization (NACI) recommends that individuals who
experienced myocarditis/pericarditis after a first dose of an mRNA COVID-19 vaccine should wait
to receive a second dose until more information is available.
- On September 29, 2021, out of an abundance of caution, Ontario issued a preferential
recommendation for the use of Pfizer-BioNTech vaccine for individuals 18-24 years of age, and
the continued use of Pfizer-BioNTech for individuals 12-17 years of age, based on an analysis of
data from Ontario’s vaccine safety surveillance system.
- The benefits of vaccination continue to outweigh the risks of COVID-19 illness and vaccination is
highly recommended for all eligible individuals, including youth.
This document provides an overview of what is currently known about events of myocarditis and
pericarditis following COVID-19 mRNA vaccines. This document will be updated as new information
becomes available.
This document was informed by a review of current literature on myocarditis/pericarditis generally and
following COVID-19 vaccination. It includes a jurisdictional scan of resources from countries such as the United States, the United Kingdom, and Israel, and organizations such as the Public Health Agency of Canada, the Centers for Disease Control and Prevention, and the World Health Organization; and a
synthesis of hand-selected peer-reviewed literature.
Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines 2
Background
In May 2021, international reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines emerged from the United States1,2 and Israel.3 Preliminary reports, which have been confirmed with additional investigation (outlined below) indicated that these cases occurred mainly in adolescents and young adults, more often in males than females, more commonly after the second dose, and typically within one week after vaccination.1,2,4 Most cases appeared to be mild and responded well to conservative treatment (e.g., non-steroidal anti-inflammatory drugs) and rest. No myocarditis/pericarditis events were initially observed with Pfizer-BioNTech5 including among 12 to 15 year old adolescents6, and Moderna7 clinical trials. Since these original reports, multiple immunization advisory groups and vaccine regulatory committees have met to discuss this vaccine signal and to provide recommendations. To date, all countries offering COVID-19 vaccination in young adults and adolescents continue to recommend their use.
Overview of Myocarditis and Pericarditis
Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the lining outside the
heart. Symptoms of both can include shortness of breath, chest pain, or the feeling of a rapid or abnormal heart rhythm.1,2,4 Other non-cardiac symptoms can include fatigue, gastrointestinal symptoms (nausea, vomiting, abdominal pain), dizziness or syncope, edema (swelling of the lower legs), or cough.4
In Ontario, baseline data for the period of 2015-2020 from the Institute for Clinical Evaluative Sciences (ICES) was available using a broad definition of myocarditis and pericarditis from the 10th revision of the International Classification of Diseases.8 The average annual incidence of myocarditis/pericarditis per 100,000 individuals for the following age groups was: 12-19 years (16.0, 95% confidence Interval [CI]: 15.1-16.9), 20-29 years (27.3, 95% CI: 26.4-28.2), 30-39 years (27.7, 95% CI: 26.7, 28.7), and 40-49 years (28.6, 95% CI: 27.7-29.7). For Ontarians 80 years of age and older, the average annual incidence of myocarditis/pericarditis (broad definition) was 78.1 per 100,000 individuals (95% CI: 75.3-81.0). Incidence was consistently higher in males than females for each of the above age groups. (Kwong J, ICES, personal communication email, 2021 Aug 5).
The list of possible causes or triggers for myocarditis/pericarditis is broad and includes both infectious (i.e., recent viral, bacterial, fungal, tuberculosis, parasitic infection) 9, and non-infectious triggers (i.e., auto-immune, connective tissue disease, metabolic (e.g., renal), malignancy, trauma, toxins, drug-induced)4,10,. Smallpox vaccination is the only vaccine that has ever been conclusively linked to myocarditis based on a significantly higher relative risk.11
Myocarditis12,13 and pericarditis14 have also been associated with recent COVID-19 infection. In two case studies and one cohort study, competitive athletes infected with SARS-CoV-2 had cardiac magnetic resonance (cMR) findings consistent with myocarditis (1.4%, 2.3%, 15%, respectively).15-17 A large nationwide Israeli study demonstrated that SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15.8) and of additional serious adverse events, including pericarditis.18
Subsequent analysis demonstrated that the risk of myocarditis and pericarditis after SARS-CoV-2 infection increased in both males and females under and over the age of 40 years. Specifically, in young male adolescents and adults ages 16-39 years old, there was an excess of 11.54 events of myocarditis per 100,000 persons (95% CI, 2.48 to 22.55).19
Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines 3
Early Reports of Myocarditis and Pericarditis Following COVID-19 Vaccination
In April 2021, an Israeli news release reported 62 cases of myocarditis out of approximately five million
doses of Pfizer-BioNTech vaccine administered.20 Of these cases, 56 occurred after dose 2, with most
occurring in men younger than 30 years of age.
In April 2021, 23 cases of symptomatic acute myocarditis presented within four days following COVID-19 mRNA vaccination (seven with Pfizer-BioNTech, 16 with Moderna) were reported by the US Department of Defence in healthy military members; twenty of which occurred after the second dose.21
Clinical Description of Events
Numerous published studies of myocarditis following COVID-19 mRNA vaccinations (Pfizer-BioNTech,
Moderna) demonstrated that these events typically present as chest pain in adolescent and young adult males, within two to seven days after their second dose.23-28 Cases were typically mild with no reported deaths. However, the majority of hospitalizations had short durations in non-ICU settings. Generally, these individuals recovered quickly with resolution of their symptoms within a couple of weeks of discharge. Troponin levels were elevated with abnormal echocardiogram and/or cMR.23-28
Epidemiology of Myocarditis/Pericarditis after COVID-19 Vaccination
Reporting Rate of Myocarditis/Pericarditis in the United States
-As of June 30, 2021, reporting rate of myocarditis overall among adults was 3.5 cases per million
second doses of mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) administered based on
data from the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system in
the US.29 In a subgroup analyses by age and sex, the reporting rate was highest among males
aged 18–29 years (24.3 cases per million mRNA COVID-19 vaccine second doses administered).
- The Vaccine Safety Datalink (VSD) is an active surveillance system in the US that uses a rapid
cycle analysis (RCA), to examine the observed number of adverse events compared with the
expected number of events.
-Klein et al. assessed the safety of the mRNA COVID-19 vaccines (Pfizer-BioNTech and
Moderna) from one to twenty-one days after dose 1 or 2 over a six month period from
December 2020 through June 2021.30 Among individuals aged 12 to 39 years, the incidence
of myocarditis/pericarditis per 1,000,000 person-years and adjusted relative risk (aRR)
during the risk versus comparison intervals was 321 versus 35 (aRR 9.83; 95%CI, 3.35-
35.77) during days 0 to 7 after vaccination after either dose 1 or 2. This corresponded to a
statistically additional 6.3 cases per million doses (p < 0.001, 95%CI, 4.9-6.8) after either
dose 1 or dose 2. The aRR estimates were higher for both Pfizer-BioNTech and Moderna
vaccines with significant clustering within the first five days of mRNA vaccination with the
risk being highest after dose two, with an excess of 11.2 (p < 0.001, 95%CI, 8.9 to 12.1)
cases per million doses in days 0 through 7 for individuals 12 to 39 years old.30
Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines 4
Reporting Rate of Myocarditis/Pericarditis in Israel
-Analysis of observational data of adverse events following mRNA vaccination from the largest
health care organization in Israel compared matched individuals forty-two days after being
vaccinated with two doses of Pfizer-BioNTech to unvaccinated individuals. Vaccination was most
strongly associated with an elevated risk of myocarditis (risk ratio, 3.24; 95% CI, 1.55 to 12.44;
risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6).18
-The risk of myocarditis increased by a factor of three after vaccination, which translated to
approximately 3 excess events per 100,000 persons (95% CI, 1 to 5 excess events per 100,000
persons).18 Among the persons with myocarditis in the vaccinated group, the median age was 25
years and 90.9% were male.
- Further analysis of adverse events following mRNA vaccination stratified by age and sex, found
that among males between 16 and 39 years old, there was an excess of 8.62 events of
myocarditis per 100,000 persons (95% CI, 2.82 to 14.35) with a risk ratio of 4.95 (95% CI, 1.61 to
16.57).19 In comparison, the excess risk for the same group following SARS CoV-2 infection was
11.54 events of myocarditis per 100,000 persons (95% CI, 2.48 to 22.55). Similarly, there was an
increased risk of pericarditis following mRNA vaccines in young males aged 16-39 years (risk
ratio, 2.67; 95% CI, 1.03 to 9.26; risk difference, 5.28 events per 100,000 persons; 95% CI, 0.17
to 10.33).
Reporting Rate of Myocarditis/Pericarditis in Canada
- Up to and including October 15, 2021, there were 956 reports of myocarditis/pericarditis to the
Public Health Agency of Canada and Health Canada.31 Of these reported cases, 573 occurred
following a Pfizer-BioNTech vaccine for a reporting rate of 1.44 events per 100,000 administered
doses. There were 357 events following Moderna vaccination for a reporting rate of 2.55 per
100,000 administered doses.
-The number of reports of myocarditis/pericarditis following the Pfizer-BioNTech is higher
than what would be expected in the general population of males and females less than 30
- The number of reports of myocarditis/pericarditis following the Moderna is higher than
what would be expected in the general population, particularly among males and females
less than 40 years old and following the second dose.31
Reporting Rate of Myocarditis/Pericarditis in Ontario
-Passively reported events of myocarditis/pericarditis following COVID-19 vaccine are higher than
expected in the general population based on trends in background rates for these types of events.32
Additional information on these events and other COVID-19 AEFI reports can be found in Public
Health Ontario’s weekly AEFI summary.
-As of October 10, 2021, there have been 438 reports of myocarditis/pericarditis following
receipt of COVID-19 mRNA vaccines in Ontario for an overall crude reporting rate of 20.9
per million doses of mRNA vaccines administered. Of these, 122 (27.9%) were diagnosed
with myocarditis and 197 (45.0%) were diagnosed with pericarditis.32
-Of the 438 reports of myocarditis/pericarditis, 242 required hospitalization (55.3%), for a
median length of stay of two days among the 210 reports for which there was an
admission and discharge date.32
EDITED: 5 Jan 19:02 by RAZZMAN