Hulscher N., Hodkinson R., Makis W., and McCullough P. A. (2024) Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis, ESC Heart Failure, doi: https://doi.org/10.1002/ehf2.14680
Hulscher N., Hodkinson R., Makis W., and McCullough P. A. (2024) Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis, ESC Heart Failure, doi: https://doi.org/10.1002/ehf2.14680
Hulscher N., Hodkinson R., Makis W., and McCullough P. A. (2024) Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis, ESC Heart Failure, doi: https://doi.org/10.1002/ehf2.14680
Hulscher N., Hodkinson R., Makis W., and McCullough P. A. (2024) Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis, ESC Heart Failure, doi: https://doi.org/10.1002/ehf2.14680
Abstract
Background: COVID-19 vaccines have been linked to myocarditis which in some circumstances can be fatal. This systematic review aims to investigate potential causal links between COVID-19 vaccines and death from myocarditis using post-mortem analysis. Methods: We performed a systematic review of all published autopsy reports involving COVID-19 vaccination-related myocarditis through July 3rd, 2023. All autopsy studies that include COVID-19 vaccine-induced myocarditis as a possible cause of death were included, without imposing any additional restrictions. Causality in each case was determined by three independent reviewers with cardiac pathology experience and expertise. Results: We initially identified 1,691 studies and, after screening for our inclusion criteria, included 14 papers that contained 28 autopsy cases. The cardiovascular system was the only organ system affected in 26 cases. In 2 cases, myocarditis was characterized as a consequence from multisystem inflammatory syndrome (MIS). The mean and median number of days from last COVID-19 vaccination until death was 6.2 and 3 days, respectively. Most of the deaths occurred within a week from the last injection. We established that all 28 deaths were causally linked to COVID-19 vaccination by independent adjudication. Conclusions: The temporal relationship, internal and external consistency seen among cases in this review with known COVID-19 vaccine-induced myocarditis, its pathobiological mechanisms and related excess death, complemented with autopsy confirmation, independent adjudication, and application of the Bradford Hill criteria to the overall epidemiology of vaccine myocarditis, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death from suspected myocarditis in cases where sudden, unexpected death has occurred in a vaccinated person. Urgent investigation is required for the purpose of risk stratification and mitigation in order to reduce the population occurrence of fatal COVID-19 vaccine-induced myocarditis.
Keywords
myocarditis; sudden death; chest pain; autopsy; necropsy; COVID-19; COVID-19 vaccines; mRNA; SARS-CoV-2 vaccination; death; excess mortality; spike protein; organ system
Subject
Medicine and Pharmacology, Cardiac and Cardiovascular Systems
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The commenter has declared there is no conflict of interests.
Comment:
This manuscript does not prove the remarkable risk of mRNA vaccines: according to numbers given in this article, the risk of death from COVID-19 is 0.009% (6,948,764 : 767,726,861), whereas the risk of death from myocarditis after mRNA vaccine, documented here, is 3.647 x 10-8 (28 : 767,726,861), i.e., five orders of magnitude lower!
Crucial 6 references out of 39 references are non-peer-reviewed web site news.
I hope that the MDPI journal will not, after opinions of reliable reviewers, accept this manuscript for publication, especially since they had already had to withdraw a similar publication at least once [Retraction: Walach et al. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines 2021, 9, 693, Vaccines Editorial Office, https://doi.org/10.3390/vaccines9070729].
The commenter has declared there is no conflict of interests.
Comment:
Mr. Kusnierczyk, your arguments are not valid. A comparison between covid and vaccine deaths says nothing (!) about the risk factor after a vaccination. Its not the point of this study to argue for or against vaccinations. Your post shows that you just want the table empty of arguments against the vaccine.
There are not 39 references, there are 58. There is no reason why there only should be "peer-reviewd" references in a paper if theiy are for illustrational purposes. Finally: in a peer-review process its not about pass or deny. Its about making it better.
The commenter has declared there is no conflict of interests.
Comment:
Mr. Kusnierczyk, when you calculate the risk of death from myocarditis after mRNA vaccine you write 28 : 767,726,861: now:
1) how can you state that *all* those deaths are *only* 28 and not more?
2) why do you relate those 28 deaths to the number of infected by SARS-CoV-2 around the world, i.e. 767,726,861? What does the former have to do with the latter?
The commenter has declared there is no conflict of interests.
Comment:
Unfortunately medicals have not a full knowledge about the Covid-19 mortality, as it is derived from official data based on irrational mechanical assumptions. In fact, if the pandemic was not announced the number of excess deaths would be only close to Zero, what can be directly proven/calculated: https://zenodo.org/record/8264060
...There is strong censorship concerning what medical journals let go (I could give examples even how many minutes it takes some of them remove an upload), so "peer-reviews" gives a strongly distorted view; besides presenting a work to such journals is no duty or will, the math proof can be verified by anybody, if it does not contain any data only in the authors' possesion.
The commenter has declared there is no conflict of interests.
Comment:
The authors state in the introduction, "A PUBMED search performed at the time of writing for “myocarditis” and “COVID-19 vaccination” yielded 994 results, indicating a high prevalence of COVID-19 vaccine-related myocarditis in the peer-reviewed literature."
A high number of papers related to an adverse evict does not imply a high prevalence of the problem; rather, it implies a widespread interest in the problem, even if rare. Obviously, after the first reports, the risk of vaccine-induced myocarditis in young people raised a bear interest in the topic, yielding many studies. But what did these studies find?
Salah HM, Mehta JL. COVID-19 Vaccine and Myocarditis. Am J Cardiol. 2021 Oct 15;157:146-148 (15 cases). conclusions are: "This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications."
Montgomery J, et al. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. 2021 Oct 1;6(10):1202-1206. : "the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. The observed number of myocarditis cases was small (23 cases)"
Oster ME, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. : ".Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. " This is NOT a high prevalence!
Patone M, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022 Feb;28(2):410-422. : "We estimated an extra two, one and six myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test."
And so on. Myocarditis has a LOW prevalence after vaccination.
The commenter has declared there is no conflict of interests.
Comment:
What is most striking from the comments section is the dismissal or objection to the papers reporting of "a high likelihood of a causal link between COVID-19 vaccines and death from suspected myocarditis in cases where sudden, unexpected death has occurred in a vaccinated person." As stated by commenters, the paper does not prove a link but indicates that a likelihood exists between the mRNA injections and the observed increase in myocarditis and pericarditis reported world-wide. This paper is a hypothesis generating paper - it should be treated as such.
Additionally, I am astounded that we we are even considering the prevalence (LOW) of cardiac damage as an acceptable trade-off for an already demonstrated low morbidity/mortality infection. Myocarditis may have "overall fast recovery with no short-term complications." but it has long-term consequences, especially with a younger (6-24 years of age) population. Heart damage is permanent. In many cases it can be sub-clinical and only detected under high-load conditions. There is a very high likelihood that under-reporting and missed diagnosis are at play in public health and epidemiological reports. This will likely be a long-term trend, as the damage cardiac tissue begins to demonstrate clinical signs -
The mRNA technology, prior to EUA in the United States, never achieved clearance or approval by FDA for the other conditions that were being pursued by Moderna or Pfizer. Clinical testing of the mRNA and delivery technology underwent significant alteration from previous formulations when using the spike-protein mRNA. The short preclinical and clinical testing period is unheard of for a product that has been designated as a vaccine. The process formulation used in the clinical trials for BNT162b2 was a PCR amplification of the mRNA sequence (Process 1). The manufacturing for the EUA Pfizer mRNA injection employed a different manufacturing process, a plasmid amplification and restriction enzyme release (Process 2) that may also influence the quality and safety of the mRNA technology.
In the US, the VAERS system has logged > 5,000 reports of myo/pericarditis from January 01, 2021 through December 29, 2023. Prior to the release of the BNT162b2 and mRNA-1273 therapies to the public, the reports of myo/pericarditis recorded in VAERS (from April 1991 to December 2020) was ~500 reports. VAERS is know to have an under-reporting bias, supporting the main hypothesis of this paper.
Finally, relying on the PCR test for SARS-Cov-2 test as a diagnostic to link the risk of infection to myocarditis is highly flawed - and using data from barely a year into the release of the mRNA therapies overlooks the increased reporting and updates that have occurred since then. The histopathology for detecting cardiac tissue damage from anti-SARS-COv-2 vaccination was released in November of 2022 (Clinical Research in Cardiology (2023) 112:431–440, https://doi.org/10.1007/s00392-022-02129-5), so the methodology for doing PROPER autopsies and biopsies is still in the early stages. This indicates that we have a higher likelihood of missing cases than we are of detecting them properly.
The commenter has declared there is no conflict of interests.
Comment:
The comment of Chiara Lestuzzi is a classical example of knee jerk reaction by a person that has bought the official narrative that tha mRNA injections are safe and effective. This article, (which was later published here: https://onlinelibrary.wiley.com/doi/10.1002/ehf2.14680 after peer review) at no point attempts to stablish a high prevalence of the myocarditis. The entire point of the article is to prove that the use of the product can be, and has been, fatal to people that otherwise would still be alive and healthy, and only died because they were injected with these products, which was done under coercion in a significative proportion of the injected people. That a product can be fatal without any prior warning is something that, in other times, when common sense was the norm, was simply enough to end the use of any product.
Commenter:
The commenter has declared there is no conflict of interests.
Crucial 6 references out of 39 references are non-peer-reviewed web site news.
I hope that the MDPI journal will not, after opinions of reliable reviewers, accept this manuscript for publication, especially since they had already had to withdraw a similar publication at least once [Retraction: Walach et al. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines 2021, 9, 693, Vaccines Editorial Office, https://doi.org/10.3390/vaccines9070729].
Commenter:
The commenter has declared there is no conflict of interests.
There are not 39 references, there are 58. There is no reason why there only should be "peer-reviewd" references in a paper if theiy are for illustrational purposes. Finally: in a peer-review process its not about pass or deny. Its about making it better.
Commenter:
The commenter has declared there is no conflict of interests.
1) how can you state that *all* those deaths are *only* 28 and not more?
2) why do you relate those 28 deaths to the number of infected by SARS-CoV-2 around the world, i.e. 767,726,861? What does the former have to do with the latter?
Thank you
Commenter:
The commenter has declared there is no conflict of interests.
https://zenodo.org/record/8264060 ...There is strong censorship concerning what medical journals let go (I could give examples even how many minutes it takes some of them remove an upload), so "peer-reviews" gives a strongly distorted view; besides presenting a work to such journals is no duty or will, the math proof can be verified by anybody, if it does not contain any data only in the authors' possesion.
Commenter:
The commenter has declared there is no conflict of interests.
A high number of papers related to an adverse evict does not imply a high prevalence of the problem; rather, it implies a widespread interest in the problem, even if rare. Obviously, after the first reports, the risk of vaccine-induced myocarditis in young people raised a bear interest in the topic, yielding many studies. But what did these studies find?
Salah HM, Mehta JL. COVID-19 Vaccine and Myocarditis. Am J Cardiol. 2021 Oct 15;157:146-148 (15 cases). conclusions are: "This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications."
Montgomery J, et al. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. 2021 Oct 1;6(10):1202-1206. : "the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. The observed number of myocarditis cases was small (23 cases)"
Oster ME, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. : ".Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. " This is NOT a high prevalence!
Patone M, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022 Feb;28(2):410-422. : "We estimated an extra two, one and six myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test."
And so on. Myocarditis has a LOW prevalence after vaccination.
Commenter:
The commenter has declared there is no conflict of interests.
Additionally, I am astounded that we we are even considering the prevalence (LOW) of cardiac damage as an acceptable trade-off for an already demonstrated low morbidity/mortality infection. Myocarditis may have "overall fast recovery with no short-term complications." but it has long-term consequences, especially with a younger (6-24 years of age) population. Heart damage is permanent. In many cases it can be sub-clinical and only detected under high-load conditions. There is a very high likelihood that under-reporting and missed diagnosis are at play in public health and epidemiological reports. This will likely be a long-term trend, as the damage cardiac tissue begins to demonstrate clinical signs -
The mRNA technology, prior to EUA in the United States, never achieved clearance or approval by FDA for the other conditions that were being pursued by Moderna or Pfizer. Clinical testing of the mRNA and delivery technology underwent significant alteration from previous formulations when using the spike-protein mRNA. The short preclinical and clinical testing period is unheard of for a product that has been designated as a vaccine. The process formulation used in the clinical trials for BNT162b2 was a PCR amplification of the mRNA sequence (Process 1). The manufacturing for the EUA Pfizer mRNA injection employed a different manufacturing process, a plasmid amplification and restriction enzyme release (Process 2) that may also influence the quality and safety of the mRNA technology.
In the US, the VAERS system has logged > 5,000 reports of myo/pericarditis from January 01, 2021 through December 29, 2023. Prior to the release of the BNT162b2 and mRNA-1273 therapies to the public, the reports of myo/pericarditis recorded in VAERS (from April 1991 to December 2020) was ~500 reports. VAERS is know to have an under-reporting bias, supporting the main hypothesis of this paper.
Finally, relying on the PCR test for SARS-Cov-2 test as a diagnostic to link the risk of infection to myocarditis is highly flawed - and using data from barely a year into the release of the mRNA therapies overlooks the increased reporting and updates that have occurred since then. The histopathology for detecting cardiac tissue damage from anti-SARS-COv-2 vaccination was released in November of 2022 (Clinical Research in Cardiology (2023) 112:431–440, https://doi.org/10.1007/s00392-022-02129-5), so the methodology for doing PROPER autopsies and biopsies is still in the early stages. This indicates that we have a higher likelihood of missing cases than we are of detecting them properly.
Commenter:
The commenter has declared there is no conflict of interests.