Post-vaccination Myocarditis (not rare, not mild) Pt.2

Exploring the scientific literature from 2022.

This post is an update from our first post on this subject,

VAERS and Myocarditis

Back in January, 2022 we already knew that rates of myocarditis ranged from 38-54 / 100k in teenage boys and young adult males after the second dose. These rates exceeded initial estimates from CDC by 10x. We had some preliminary data showing higher rates of myocarditis from vaccination than infection. We also knew that long-term outcomes were unknown and required more study. Since then, a dozen or so pivotal studies have been published casting more doubt on the mild and rare narrative. Let’s take a look.

Not rare

In addition to the evidence we published initially, even more studies have emerged in 2022 which further solidify this claim. Firstly, a large study of 23 million residents of Nordic countries revealed that in males aged 16-24 rates of myocarditis were 4-14x (Table 2) higher after vaccination compared to unvaccinated controls

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. These rates were even higher when a different vaccine product (Pfizer or Moderna) was used between doses. Next, in the first prospective study ever published where participants were actively monitored, 7/202 (3.5%) males aged 13-18 were diagnosed with myo/pericarditis, working out to a rate of 1 in 28

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, significantly higher than anything seen yet. Lastly, in a study published earlier this year, males aged 12-17 were found to have a higher risk of hospitalization from post-vaccination myocarditis than from an actual COVID-19 infection

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More recent studies are now starting to expose rates of myocarditis are even higher after booster doses

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Not mild

A number of case studies were published in 2022 regarding the severity of this adverse event, they found the following:

• 96% (784/813) of those diagnosed with post-vaccination myocarditis required hospitalization

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• Cardiac magnetic resonance imaging (CMR) found the potential for myocardial fibrosis in 100% (13/13) of patients with unknown long-term impact

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• Late gadolinium enhancement (LGE), a predictor of cardiovascular death, was found in 69% (11/16) of patients 3-8 months after initial diagnosis

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• 26% (104/393) of individuals recovered were on myocarditis medication, cardiac abnormalities were found in 54% (81/151), and 32% (125/393) were not cleared for physical activity at 90-day follow-up

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• 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination

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Additionally, people diagnosed with myo/pericarditis are recommended to refrain from competitive athletics and vigorous exercise for at least 6 months

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These studies capture short to mid-term outcomes. One study looking at long-term outcomes of non-viral myocarditis found that ejection fraction, another predictor of cardiovascular death, did not recover to normal levels in 50% (99/210) of patients two years later

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Historically, safety signals like this would have been caught by post-marketing surveillance programs but the FDA has publicly acknowledged existing systems are insufficient to assess this risk (Page 6)

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Infection or Vaccine

Many justify the risk by claiming myocarditis is more likely after infection than vaccination. However, a study of 200,000 found no difference between the background rate of myocarditis in uninfected compared to those recovering from a COVID-19 infection

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Moreover, from the aforementioned Nordic study, myocarditis was found to be 2-8x more prevalent after vaccination compared to COVID-19 infection in males aged 16-24 (eTable 7, Supplementary Material). Even men up to the age of 40 had a ~3x higher rate of myocarditis after vaccination with Moderna than infection(1).

The science is disputed on this topic, as recent meta-analysis studies have shown the opposite to be true

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. However, when evaluating medical products, especially those under Emergency Use Authorization, we must err on the side of caution and take especially serious data showing harm. This is inline with a core principle of bioethics called non-maleficence which asserts an obligation not to inflict harm intentionally.

Mechanism of Action

In an ideal world, a responsible government would prioritize the safety of their populace above all else and do whatever it takes to figure out the root cause. Instead, we rely almost entirely on small groups of expert individuals to further our scientific understanding.

One prominent theory, termed Spike Protein Endothelial Disease (SPED), hypothesizes the Spike protein being at the heart of a number of conditions, including myocarditis, excess death, blood clots, as well as being the cause of Long COVID-type symptoms. I highly encourage you to read all about it at the following substack:

All Roads Lead From SPED: Cancer, Fibrosis and Neurodegeneration All Induced By SPED

How could the vaccine be exacerbating the damage, compared to natural infection?

Well, despite assurances that the Spike protein would only last a few days in our body, a January 2022 study revealed it could be detected in humans up to two months post-vaccination

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. The truth is that we simply do not know how much Spike protein is generated by our bodies or how long it stays in our system post-vaccination, as those pharmacokinetic studies were never conducted. One hypothesis states that people are exposed to a much higher level of Spike protein after vaccination than after infection.

Summary

Pouring over the scientific literature this past year has only raised more questions about the rareness of post-vaccination myocarditis in males under 40, but particularly those aged 16-24. It has also strengthened the argument that, in this age group, prevalence of myocarditis is higher post-vaccination than post-infection. We now know more about the severity of short to mid-term outcomes, including hospitalization, impaired indicators of heart function, and increased levels of cardiac death. We also now have some working hypothesis as to the underlying mechanisms of action behind this cardiac damage.

Ultimately, post-vaccination myocarditis is much more common and severe than initially thought which begs the question:

Why do our governments continue to ignore this safety signal and the data associated with it?

#DemandTheTruth

1. SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents
https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253

2. Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents
https://www.mdpi.com/2414-6366/7/8/196

3. BNT162b2 Vaccine-Associated Myo/Pericarditis in Adolescents: A Stratified Risk-Benefit Analysis
https://onlinelibrary.wiley.com/doi/10.1111/eci.13759

4. Observed versus expected rates of myocarditis after SARS-CoV-2 vaccination: a population-based cohort study
https://www.cmaj.ca/content/194/45/E1529

5. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021
https://jamanetwork.com/journals/jama/fullarticle/2788346

6. Myopericarditis After the Pfizer Messenger Ribonucleic Acid Coronavirus Disease Vaccine in Adolescents
https://www.jpeds.com/article/S0022-3476(21)00665-X/fulltext

7. Persistent Cardiac Magnetic Resonance Imaging Findings in a Cohort of Adolescents with Post-Coronavirus Disease 2019 mRNA Vaccine Myopericarditishttps://www.jpeds.com/article/S0022-3476(22)00282-7/fulltext

8. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study
https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext

9. Exploring the relationship between all-cause and cardiac-related mortality following COVID-19 vaccination or infection in Florida residents: a self-controlled case series study
https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf

10. Diagnosis and Treatment of Myocarditis in Children in the Current Era
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.113.001372

11. Management of Myocarditis-Related Cardiomyopathy in Adults
https://www.ahajournals.org/doi/full/10.1161/CIRCRESAHA.118.313578

12. https://www.fda.gov/media/151710/download

13. The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients—A Large Population-Based Study
https://www.mdpi.com/2077-0383/11/8/2219

14. Myocarditis in SARS-CoV-2 infection vs. COVID-19 vaccination: A systematic review and meta-analysis
https://www.frontiersin.org/articles/10.3389/fcvm.2022.951314/full

15. Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination
https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9