Letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’ DOI Creative Commons
Hannah Van Wyk, Mia Q. Zhu,

Danielle R. Stone

et al.

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2467 - 2468

Published: April 25, 2024

Vaccination is a well-proven public health intervention. Since the latter half of 20th century, vaccination policies have been increasingly informed by peer-reviewed publications. Given this, Hulscher et al.1 may major implications on public's and perception COVID-19 vaccination. However, we believe conclusions drawn authors fail to match methodologies used. Therefore, caution should be exercised readers when drawing from study findings. The individual-level causal effects myocarditis deaths were poorly established in selected autopsy cases. First, information relevant covariates was limited. Covariates recorded Table 1 included sex, age, vaccine dose number, time between myocarditis, brand, notes.1 important variables that associated with death including non-cardiac comorbidities exposure other vaccinations or medications missing. In addition, demographic never discussed. Previous research shows risk only those younger than 40.2 Of 28 cases, 14 older 40 years age. These cases attributed vaccination, contrary prior evidence, require higher burden proof causality, which not provided authors. Furthermore, temporality association some Five occurred fewer 2 days after While before death, date initial signs symptoms reported. five where times so short, it biologically improbable onset due needed mount an immune response antigens result myocarditis. Finally, coincidental causes cannot ruled out given provided. Comorbidities contributing include genetically programmed disease, drug toxin over acceptable level, even non-measured infections present at immunization.3 al. failed address any potential comorbidities, instead used existence these as reason for '… establish[ing] all most likely causally linked independent review clinical presented each paper'.1 cited case reports, themselves stated inference made based their For example, commentary, Verma4 found fulminant report sample two individuals assessed PCR testing reported COVID-19. own discussion section, concluded no direct relationship could established. To further support hypothesis invoked Bradford Hill criteria. noted rather serving definitive checklist determine criteria are intended provide framework considerations constructing epidemiological assessments causality.5 this application, World Health Organization (WHO) establishing causality adverse event3 widely accepted. WHO consideration temporality, alternative explanations, association, biological plausibility, population-based conclude association. met, greatest missing component series autopsies. absence such would fall into either 'indeterminate' 'inconsistent association' categories. fact, conducted population-level assessment excess vaccinated groups.2 identified many inconsistencies misrepresented referenced papers various forms. opened Discussion section assertion findings link consistent available literature topic, referencing 994 retrieved PubMed through keyword search terms ('myocarditis' AND 'COVID-19 vaccination'). A alone sufficient articles agreement nor they investigated specific there several instances retracted peer-reviewed. one Skidmore3 marked editor's note regarding unsubstantiated claims 26 January 2023, resulting retraction 11 April approximately 9 months publication Lastly, estimate 709 740 people died countries using Vaccine Adverse Event Reporting System (VAERS). This estimation obtained multiplying 35 487 VAERS 16 June 2023 assumed underreporting factor 20, non source. small fraction total attributable vaccine, inconsistent claim specifically. text also fails acknowledge well-known limitations generate estimates, reports self-reported independently screened professionals. Consequently, use data make strong inappropriate. summary, vaccine-induced attempted extrapolate discussions population Research both pathophysiological evidence safety crucial. al.'s paper problematic key ways. justified. Second, lack baseline following infection precludes population. limitations, restrained appropriately reflect its design methods; interpretations Correspondingly, evaluate communicate impact mortality.

Language: Английский

Letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’ DOI Creative Commons
Hannah Van Wyk, Mia Q. Zhu,

Danielle R. Stone

et al.

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2467 - 2468

Published: April 25, 2024

Vaccination is a well-proven public health intervention. Since the latter half of 20th century, vaccination policies have been increasingly informed by peer-reviewed publications. Given this, Hulscher et al.1 may major implications on public's and perception COVID-19 vaccination. However, we believe conclusions drawn authors fail to match methodologies used. Therefore, caution should be exercised readers when drawing from study findings. The individual-level causal effects myocarditis deaths were poorly established in selected autopsy cases. First, information relevant covariates was limited. Covariates recorded Table 1 included sex, age, vaccine dose number, time between myocarditis, brand, notes.1 important variables that associated with death including non-cardiac comorbidities exposure other vaccinations or medications missing. In addition, demographic never discussed. Previous research shows risk only those younger than 40.2 Of 28 cases, 14 older 40 years age. These cases attributed vaccination, contrary prior evidence, require higher burden proof causality, which not provided authors. Furthermore, temporality association some Five occurred fewer 2 days after While before death, date initial signs symptoms reported. five where times so short, it biologically improbable onset due needed mount an immune response antigens result myocarditis. Finally, coincidental causes cannot ruled out given provided. Comorbidities contributing include genetically programmed disease, drug toxin over acceptable level, even non-measured infections present at immunization.3 al. failed address any potential comorbidities, instead used existence these as reason for '… establish[ing] all most likely causally linked independent review clinical presented each paper'.1 cited case reports, themselves stated inference made based their For example, commentary, Verma4 found fulminant report sample two individuals assessed PCR testing reported COVID-19. own discussion section, concluded no direct relationship could established. To further support hypothesis invoked Bradford Hill criteria. noted rather serving definitive checklist determine criteria are intended provide framework considerations constructing epidemiological assessments causality.5 this application, World Health Organization (WHO) establishing causality adverse event3 widely accepted. WHO consideration temporality, alternative explanations, association, biological plausibility, population-based conclude association. met, greatest missing component series autopsies. absence such would fall into either 'indeterminate' 'inconsistent association' categories. fact, conducted population-level assessment excess vaccinated groups.2 identified many inconsistencies misrepresented referenced papers various forms. opened Discussion section assertion findings link consistent available literature topic, referencing 994 retrieved PubMed through keyword search terms ('myocarditis' AND 'COVID-19 vaccination'). A alone sufficient articles agreement nor they investigated specific there several instances retracted peer-reviewed. one Skidmore3 marked editor's note regarding unsubstantiated claims 26 January 2023, resulting retraction 11 April approximately 9 months publication Lastly, estimate 709 740 people died countries using Vaccine Adverse Event Reporting System (VAERS). This estimation obtained multiplying 35 487 VAERS 16 June 2023 assumed underreporting factor 20, non source. small fraction total attributable vaccine, inconsistent claim specifically. text also fails acknowledge well-known limitations generate estimates, reports self-reported independently screened professionals. Consequently, use data make strong inappropriate. summary, vaccine-induced attempted extrapolate discussions population Research both pathophysiological evidence safety crucial. al.'s paper problematic key ways. justified. Second, lack baseline following infection precludes population. limitations, restrained appropriately reflect its design methods; interpretations Correspondingly, evaluate communicate impact mortality.

Language: Английский

Citations

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