Myocarditis or Pericarditis – is known as inflammation of the heart muscle or the inflammation of the outer covering ‘sac’ of the heart (1). COVID 19, the clinical presentation of the SARS CoV2 virus, is also known to be associated with episodes of these conditions (2). Within Australia currently, there have been no officially attributed deaths from myo/pericarditis to the vaccines, however there have been overseas (3). However, the Therapeutic Goods Association (TGA) adverse event reporting system, at the time of writing, indicates 149 cases of myocarditis and/or pericarditis have been reported to the TGA post vaccination (4). The TGA note that there is a causal link between the vaccine and myo/pericarditis, yet insist the risk outweighs the benefit (5). However, there may be long term- if not life-long consequences from this vaccine-induced injury (6).
Aetiology and Epidemiology of Myocarditis
Myocarditis is inflammation of the myocardium and is most associated with viral conditions – whether the individual was aware of illness or not (7). It is known to be a heterogeneous disease, caused by several different virus’ including adenovirus’ and influenza virus after respiratory infection. It presents with a variety of symptoms that may mimic other conditions initially such as; chest pain, shortness of breath, fatigue through to cardiogenic shock requiring intubation and inotropes, heart transplant and even sudden cardiac death (7). Myocarditis often to a type of cardiomyopathy requiring long term medical therapy to assist in the management and hoped recovery of cardiac function (8). The current global incidence is likely under-estimated and is thought to be anywhere from 10.2 to 105 cases per 100,000 individuals (7). Prevalence varies between geographical location across the globe – this may represent reporting bias as well as true incidence in warmer or cooler climates. Age incidence for NON-SARS CoV-2 acquired myocarditis is said to be around age 40 +/- 17 years and impacts men at a considerably higher rate than women (7) Interestingly, though data continues to emerge, the current incidence age for this condition when associated with wild type SARS Cov-2 based on a recent systematic review was seen in predominantly males with a mean age of 50.4 (2).
COVID Vaccines and myo/pericarditis
Cases of myocarditis are emerging with the roll out of the SARS CoV-2 vaccines – particularly the mRNA based vaccines (6, 9). Data from Israel, one of the worlds most vaccinated countries by percentage, shows an alarming increase in myocarditis cases in very young men and teens after receiving the second dose of the vaccine. This has been considered to be a causal link with an incidence rate between 1 in 3000 to 1 in 6000 individuals 16 to 24 years (10). This age group is uncharacteristic for the epidemiological data presented above. Very recent articles have shown case reports of myo/pericarditis in individuals as young as 12 with confirmed ventricular dysfunction and confirmed with cardiac imaging (1). At this stage, the reported incidence data shows consistent with a background published incidence rate (assuming ALL cases are reported), however, what is most concerning is the age of incidence of myo/pericarditis from the vaccines, in a group of individuals who have an infection fatality rate (IFR) of around .0010% for contracting wild type SARS Cov-2 (11). It is known from American data that under-reporting of vaccine adverse events is significant (12). Furthermore, the incidence rate of vaccine induced myocarditis is already ‘on par’ in a few short months with decade established incidence data, suggesting an elevated trajectory if continued.
In May 2021, the senior editor of the British Medical Journal Peter Doshi published a feature article questioning the speed of the vaccine role out (13). Contrary to popular media rhetoric, in no country have any of the COVID 19 vaccines been granted full regulatory approval at the time of writing. They all remain under emergency or provisional approval use only with formal clinical trials expected to finish in 2023 (13, 14). As highlighted in this article, as millions are vaccinated globally, it may come as a surprise that no vaccine is formally approved and, on paper at least, the phase III clinical trials continue with the idea that ‘participants’ are followed up for two years (13, 14). In a ‘normal’ clinical trial, this is carried out under strict Good Clinical Practice Guidelines, yet, we are seeing a very different approach for the fast-tracked vaccines. For those young people who are displaying unexpected incidences of myocarditis or pericarditis and subsequent heart damage, there is no control group to compare with, that normally, would provide appropriate comparison between control and intervention groups. IE: does the intervention group have a higher rate of myocarditis that the control group with this vaccine? We can never answer that question. Is it normal for an 18-year-old or younger to develop myocarditis? It happens, but is rare and when it does, can be severe (15). Yet, the language is often framed in such a way that it is a mild condition or due to ‘random chance’ (16). Based on the epidemiological data discussed, random chance is not supported and, even in wild SARS CoV-2 virus exposure, the average age of myocarditis was much older, supporting the argument that these vaccines are, indeed, causing myocarditis in this age group. With an IFR that is so low, can it truly be argued that the risk outweighs the benefit for adults under 30 years of age? Moreover, as a health professional with decades of adult cardiology experience, I have rarely experienced a case of ‘mild’ myocarditis and would argue, that no case of myo/pericarditis in a 12-24 year old is mild because it is not expected in healthy individuals.
The push in Australia for universal vaccination does not consider the low levels of IFR and low levels of symptom burden in those under 30-40 or younger. Whilst it is true we have seen in Australia young people admitted to hospital and ICU with COVID-19, overall, the global data is clearly weighted towards significantly higher IFR in those over 80 (11). Furthermore, comorbidities of young people in hospital have not been identified.
I look forward to a day when our government and state leaders look more broadly at what it means health means. The lack of meaningful leadership regarding staying well with COVID 19 or SARS Cov-2 and staying out of hospital has been blind-sided by the narrow focus on vaccinating everyone. However, the goal of this paper is not to discuss the clear correlation between metabolic illness and vitamin deficiency known to be associated with poor COVID-19 outcomes (17), but rather to highlight that we are putting at risk a young generation of people who may never recover fully from the vaccine induced myocarditis or associated cardiomyopathy.
The authors name has been withheld. The author is an Australian registered health professional with over 2 decades in health and more specifically in the area of Cardiology. They have Post-Graduate qualifications in Public Health.
1. Dionne A, Sperotto F, Chamberlain S, Baker AL, Powell AJ, Prakash A, et al. Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children. JAMA Cardiology. 2021.
2. Sawalha K, Abozenah M, Kadado AJ, Battisha A, Al-Akchar M, Salerno C, et al. Systematic Review of COVID-19 Related Myocarditis: Insights on Management and Outcome. Cardiovascular revascularization medicine : including molecular interventions. 2021;23:107-13.
3. Gallagher J. Heart inflammation link to Pfizer and Moderna jabs: British Broadcasting Coorporation; 2021 [cited 2021 10th July ]. Available from: https://www.bbc.com/news/health-57781637.
4. Health Do. COVID-19 vaccine weekly safety report – 12-08-2021: Australian Government 2021 [cited 2021 16th August ]. Available from: https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-12-08-2021.
5. Health Do. COVID-19 vaccine weekly safety report – 29-07-2021: Australian Government 2021 [cited 2021 16th August ]. Available from: https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-29-07-2021.
6. Shay DK, Shimabukuro TT, DeStefano F. Myocarditis Occurring After Immunization With mRNA-Based COVID-19 Vaccines. JAMA Cardiology. 2021.
7. Golpour A, Patriki D, Hanson PJ, McManus B, Heidecker B. Epidemiological Impact of Myocarditis. Journal of clinical medicine. 2021;10(4).
8. Mason JW. Myocarditis and dilated cardiomyopathy: An inflammatory link. Cardiovascular Research. 2003;60(1):5-10.
9. Montgomery J, Ryan M, Engler R, Hoffman D, McClenathan B, Collins L, et al. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021.
10. Gretchen Vogel JC-F. Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men 2021 [cited 2021 10th July ]. Available from: https://www.sciencemag.org/news/2021/06/israel-reports-link-between-rare-cases-heart-inflammation-and-covid-19-vaccination.
11. O’Driscoll M, Ribeiro Dos Santos G, Wang L, Cummings DAT, Azman AS, Paireau J, et al. Age-specific mortality and immunity patterns of SARS-CoV-2. Nature. 2021;590(7844):140-5.
12. Ross L, Klompas, M, . Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS). Harvard Pilgrim HealthCare 2010.
13. Doshi P. Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ. 2021;373:n1244.
14. Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals 2020 [cited 2021 10th July ]. Available from: https://clinicaltrials.gov/ct2/show/NCT04368728.
15. Fung RCM, Hon KL, Leung AKC. Acute Myocarditis in Children: An Overview of Treatment and Recent Patents. Recent patents on inflammation & allergy drug discovery. 2020;14(2):106-16.
16. R MLaC. Heart health warning for Pfizer jab Fairfax Media 2021 [updated 10th July 2021. Available from: https://www.smh.com.au/national/heart-inflammation-warning-added-to-pfizer-jab-20210709-p588g9.html.
17. Zhou Y, Chi J, Lv W, Wang Y. Obesity and diabetes as high-risk factors for severe coronavirus disease 2019 (Covid-19). Diabetes/metabolism research and reviews. 2021;37(2):e3377.