Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis

ESC Heart Failure, Год журнала: 2024, Номер unknown

Опубликована: Янв. 14, 2024

Abstract COVID‐19 vaccines have been linked to myocarditis, which, in some circumstances, can be fatal. This systematic review aims investigate potential causal links between and death from myocarditis using post‐mortem analysis. We performed a of all published autopsy reports involving vaccination‐induced through 3 July 2023. All studies that include vaccine‐induced as possible cause were included. Causality each case was assessed by three independent physicians with cardiac pathology experience expertise. initially identified 1691 and, after screening for our inclusion criteria, included 14 papers contained 28 cases. The cardiovascular system the only organ affected 26 In two cases, characterized consequence multisystem inflammatory syndrome. mean age 44.4 years old. median number days last vaccination until 6.2 days, respectively. established deaths most likely causally clinical information presented paper. temporal relationship, internal external consistency seen among cases this known its pathobiological mechanisms, related excess death, complemented confirmation, adjudication, application Bradford Hill criteria overall epidemiology vaccine suggests there is high likelihood link myocarditis.

Язык: Английский

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mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues

International Journal of Molecular Sciences, Год журнала: 2023, Номер 24(13), С. 10514 - 10514

Опубликована: Июнь 22, 2023

COVID-19 vaccines were developed and approved rapidly in response to the urgency created by pandemic. No specific regulations existed at time they marketed. The regulatory agencies therefore adapted them as a matter of urgency. Now that pandemic emergency has passed, it is consider safety issues associated with this rapid approval. mode action mRNA should classify gene therapy products (GTPs), but have been excluded agencies. Some tests undergone produced non-compliant results terms purity, quality batch homogeneity. wide persistent biodistribution mRNAs their protein products, incompletely studied due classification vaccines, raises issues. Post-marketing studies shown passes into breast milk could adverse effects on breast-fed babies. Long-term expression, integration genome, transmission germline, passage sperm, embryo/fetal perinatal toxicity, genotoxicity tumorigenicity be light events reported pharmacovigilance databases. potential horizontal (i.e., shedding) also assessed. In-depth vaccinovigilance carried out. We would expect these controls required for future outside context

Язык: Английский

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COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign

Cureus, Год журнала: 2024, Номер unknown

Опубликована: Янв. 24, 2024

Our understanding of COVID-19 vaccinations and their impact on health mortality has evolved substantially since the first vaccine rollouts. Published reports from original randomized phase 3 trials concluded that mRNA vaccines could greatly reduce symptoms. In interim, problems with methods, execution, reporting these pivotal have emerged. Re-analysis Pfizer trial data identified statistically significant increases in serious adverse events (SAEs) group. Numerous SAEs were following Emergency Use Authorization (EUA), including death, cancer, cardiac events, various autoimmune, hematological, reproductive, neurological disorders. Furthermore, products never underwent adequate safety toxicological testing accordance previously established scientific standards. Among other major topics addressed this narrative review are published analyses harms to humans, quality control issues process-related impurities, mechanisms underlying (AEs), immunologic basis for inefficacy, concerning trends based registrational data. The risk-benefit imbalance substantiated by evidence date contraindicates further booster injections suggests that, at a minimum, should be removed childhood immunization program until proper studies conducted. Federal agency approval blanket-coverage population-wide had no support an honest assessment all relevant commensurate consideration risks versus benefits. Given extensive, well-documented unacceptably high harm-to-reward ratio, we urge governments endorse global moratorium modified questions pertaining causality, residual DNA, aberrant protein production answered.

Язык: Английский

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Autoimmune inflammatory reactions triggered by the COVID-19 genetic vaccines in terminally differentiated tissues

Autoimmunity, Год журнала: 2023, Номер 56(1)

Опубликована: Сен. 14, 2023

As a result of the spread SARS-CoV-2, global pandemic was declared. Indiscriminate COVID-19 vaccination has been extended to include age groups and naturally immune people with minimal danger suffering serious complications due COVID-19. Solid immuno-histopathological evidence demonstrates that genetic vaccines can display wide distribution within body, affecting tissues are terminally differentiated far away from injection site. These heart brain, which may incur in situ production spike protein eliciting strong autoimmunological inflammatory response. Due fact every human cell synthesises non-self antigens, inevitably becomes target system, since body is not strictly compartmentalised accurate pharmacokinetic pharmacodynamic studies needed order determine precisely be harmed. Therefore, our article aims draw attention scientific regulatory communities critical need for biodistribution against COVID-19, as well rational harm-benefit assessments by group.

Язык: Английский

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Risk stratification for future cardiac arrest after COVID-19 vaccination

World Journal of Cardiology, Год журнала: 2025, Номер 17(2)

Опубликована: Фев. 24, 2025

Unheralded cardiac arrest among previously healthy young people without antecedent illness, months or years after coronavirus disease 2019 (COVID-19) vaccination, highlights the urgent need for risk stratification. The most likely underlying pathophysiology is subclinical myopericarditis and reentrant ventricular tachycardia spontaneous fibrillation that commonly precipitated a surge in catecholamines during exercise waking hours of terminal sleep. Small patches inflammation and/or edema can be missed on imaging autopsy, heart appear grossly normal. This paper reviews evidence linking COVID-19 vaccines to where unfortunately majority victims have had no clinical evaluation. We propose comprehensive strategy evaluating cardiovascular post-vaccination, incorporating detailed patient history, antibody testing, diagnostics best attempt detect abnormalities before sudden death. approach aims identify individuals at higher events vaccination guide appropriate management. It prudent each primary care physician pre-established plan when addressing this issue their practice.

Язык: Английский

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What Lessons can Be Learned From the Management of the COVID-19 Pandemic?

International Journal of Public Health, Год журнала: 2025, Номер 70

Опубликована: Май 30, 2025

Язык: Английский

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mRNA: vaccine or gene therapy? The safety regulatory issues

Опубликована: Июнь 26, 2023

COVID-19 vaccines were developed and approved rapidly in response to the urgency created by pandemic. No specific regulations existed at time they marketed. The regulatory agencies therefore adapted them as a matter of urgency. Now that pandemic emergency has passed, it's consider safety issues associated with this rapid approval. mode action mRNA should classify gene therapy products (GTPs), but have been excluded agencies. Some tests undergone produced non-compliant results terms purity, quality batch homogeneity. wide persistent biodistribution mRNAs their protein products, incompletely studied due classification vaccines, raises issues. Post-marketing studies shown passes into breast milk could adverse effects on breast-fed babies. Long-term expression, integration genome, transmission germline, passage sperm, embryo/fetal perinatal toxicity, genotoxicity tumorigenicity be light events reported pharmacovigilance databases. Potential horizontal (ie shedding) also assessed. In-depth vaccinovigilance carried out. We would expect these controls required for future outside context

Язык: Английский

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Assessment of Risk for Sudden Cardiac Death Among Adolescents and Young Adults After Receipt of COVID-19 Vaccine — Oregon, June 2021–December 2022

MMWR Morbidity and Mortality Weekly Report, Год журнала: 2024, Номер 73(14), С. 317 - 320

Опубликована: Апрель 11, 2024

COVID-19 vaccination has been associated with myocarditis in adolescents and young adults, concerns have raised about possible vaccine-related cardiac fatalities this age group.In April 2021, cases of after vaccination, particularly among male vaccine recipients, were reported to the Vaccine Adverse Event Reporting System.To assess possibility, investigators searched death certificates for Oregon residents aged 16-30 years who died during June 2021-December 2022 or undetermined causes death.For identified decedents, records Oregon's immunization information system reviewed documentation mRNA received ≤100 days before death.Among 1,292 deaths, was cited as cause 30.For 101 others, a could not be excluded; these available 88, three whom had an within 100 death.Of 40 deaths that occurred persons dose, vaccination.Two attributed chronic underlying conditions; one.No certificate vaccination.These data do support association between receipt sudden previously healthy persons.COVID-19 is recommended all ≥6 months prevent complications, including death.

Язык: Английский

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COVID-19 Modified mRNA “Vaccines”: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex, Part 2

International Journal of Vaccine Theory Practice and Research, Год журнала: 2024, Номер 3(2), С. 1275 - 1344

Опубликована: Авг. 16, 2024

The COVID-19 modified mRNA (modmRNA) lipid nanoparticle-based “vaccines” are not classical antigen-based vaccines but instead prodrugs informed by gene therapy technology. Of considerable note, these products have been linked to atypical adverse and serious event profiles. As discussed in Part 1, health-related risks drawbacks were drastically misreported underreported the Pfizer Moderna trial evaluations of genetic products. Now 2, we examine main structural functional aspects injectables. modmRNA injectable introduce a unique set biological challenges human body with potential induce an extensive range adverse, crippling, life-threatening effects. Based on fact that there is no current method quantify host (cell-based) spike protein production vivo following injection prodrugs, standard “dose”. This part due differences output, which depends cell metabolism transfection efficiency. It therefore difficult predict profiles individual basis, considering millions adults across world reported severe events context products, valid concerns raised regarding infants younger age groups for whom poses only minimal risks. We address process-related impurities inherent mass posed contaminants. then categorize principal associated brief systems-based synopsis each six domains harms: (1) cardiovascular, (2) neurological, (3) hematologic; (4) immunological, (5) oncological, (6) reproductive. conclude discussion primary public health regulatory issues arising from this evidence-informed synthesis literature reiterate urgency imposing global moratorium modmRNA-LNP-based platform.

Язык: Английский

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Response to: Szuster‐Ciesielska, letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’

ESC Heart Failure, Год журнала: 2024, Номер 11(4), С. 2479 - 2480

Опубликована: Май 22, 2024

We appreciate concerns expressed by Szuster-Ciesielska about COVID-19 vaccination playing a role in sudden unexplained deaths reported athletes after the institution of mandates Europe. Cadegiani has pointed out that setting vaccine induced myocarditis, surge catecholamines may play initiation lethal ventricular arrhythmias and cardiac arrest.1 In absence an autopsy death previously healthy player, antecedent subclinical myocarditis would be reasonable consideration given findings our paper,2 as inferred work Polykretis McCullough.3 Importantly, McCullough re-analysed data response to letter editor: 'We stratified age found 558 were ≤35 years 139 over 35 years. Such number documented events is likely largely underestimated, because difficulty gather from countries where script/alphabet not translatable. Notably, 38-years timespan (1966-2004), 1101 under died (~29/year) due various heart-related conditions, 50% whom had congenital anatomical heart disease cardiomyopathies 10% atherosclerotic with early onset. The finding 697 2021 forward [<24 months] concerning for secular change these suggest research registry unexpected arrest should initiated particular attention administration data'.3 other words, nearly 10-fold increase rollout was observed. report relied upon public blog athlete required multiple press releases confirmation occurred active player.4 At this time, there no scientific collates reports among vaccinated players, however, present paper suggests such important valuable field. conclusion, contributes knowledge understanding fatal vaccine-induced adhering rigorous standards while navigating challenges sourcing generalizable observations novel rapidly evolving thank their careful analysis share regarding sharp during period enforced European sports teams. RH WM are longer associated Wellness Company. PM receives salary support (modest) or equity Company, which original manuscript correspondence.

Язык: Английский

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