Response to: Van Wyk et al. letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’ DOI Creative Commons
Nicolas Hulscher,

Roger Hodkinson,

William Makis

et al.

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2476 - 2478

Published: May 21, 2024

We thank Van Wyk et al. for their concerns about fatal COVID-19 vaccine induced myocarditis.1 agree with that papers such as ours should have 'major implications the public's health and perception of vaccination.' emphasized importance covariate information. Because each included case presented a dataset, covariates to degree they were disclosed considered in adjudication process. present all available information Table 1, including any co-morbities studies presented. Adjudicators reviewed vignettes described original reports. found none comorbidities proximate cause death. In cases, autopsy findings revealed myocarditis was primary Myocarditis has been linked vaccination years by Centers Disease Control Prevention (CDC).2 When performing autopsies, possible aetiologies are investigated, final death is assigned based upon clinical judgement examiner(s). mentioned temporality poorly established five cases died within 2 days after vaccination, however, this timeframe consistent production Spike protein, cardiac inflammation, resultant lethal arrhythmias. Patone an increased risk 28-day window vaccination.3 often results sudden before other symptoms appear.4 Since time writing our publication, more evidence published supporting biological mechanisms myocarditis. Isolated vaccine-induced protein causing cardiovascular inflammation myocarditis5, 6 may not be only mechanism(s) damage. Krauson mRNA, accompanied histologically confirmed myocardial injury, hearts individuals 30 vaccination.7 Schreckenberg inoculated adult rat cardiomyocytes mRNA-1273 (Moderna) BNT162b2 (Pfizer) resulted cellular dysfunctions seen cardiomyopathy.8 Along mRNA resulting adjuvants play role heart damage Kanuri Sirrkay.9 al.'s point World Health Organization (WHO) criteria considered. It WHO adverse event following immunization (AEFI) methodology10 emphasizes documents, complete medical history, results. For individual assessment, process met AEFI standards. raised issue on population level. important but beyond scope manuscript. The US Food Drug Administration Center Biologics Evaluation Research (CBER) designated follow-up period 5 15 novel genetic products, vaccines, observe effects might emerge exposed over time.11 2024, paper published, largest safety study date, conducted Global Vaccine Data Network (GVDN), published.12 multi-country study, which approximately 99 million vaccinated individuals, researchers observed notably higher than expected vaccinations. Specifically, dose two from vaccines 6.10 2.86 times baseline rates, respectively.12 Rose analysed Adverse Event Reporting System (VAERS) number reports 2021 223 average combined past years, concluding strongly associated serious signal myocarditis, hospitalization death.13 recognized transparency literature search paper, Figure 1 fully numbers screened, reviewed, included. we unaware missed during review period. Pantazatos14 Aarstad15 discussion, because preprints vital disseminating while undergo months long peer-review process.16 Skidmore17 retracted violation Committee Publication Ethics (COPE) guidelines18 republished at another journal.19 estimate 709 740 result derived applying underreporting factor VAERS data, indeed extrapolation requires careful interpretation support highlighted. well main limitation underreporting,20, 21 written official guide interpreting data.22 estimated fewer 1% events reported VAERS.19 While there no factor, it approximated fall range 20–40.13, 14, 23 Thus, Pantazatos al.14 20 utilized well-supported conservative estimate. Meissner 86% completed professionals or manufacturers.24 Healthcare submitting provide comprehensive vignettes, identity contact thoroughly documented under penalty law false reporting. can inferred reliable CDC verification. Overall, since new provided further population-level associations between myocarditis.12, 13 Additionally, now deleterious components protein,5, mRNA7, 8 adjuvants.9 coworkers state, 'we believe fails appropriately evaluate communicate impact mortality', implicate complication even larger public future published. these comments conclusions strong call continued vigilance research aimed mitigating outcome vaccination. RH WM longer Wellness Company. PM receives salary (modest) equity Company, had manuscript correspondence.

Language: Английский

Serious adverse events following immunization and predictors of mortality associated with COVID-19 vaccination in India: a secondary data analysis of nationwide causality assessments DOI Creative Commons
A. K. RAJAN, MA Bashar

Therapeutic Advances in Vaccines and Immunotherapy, Journal Year: 2025, Volume and Issue: 13

Published: Jan. 1, 2025

Vaccines against COVID-19 were viewed as a way out to the ongoing pandemic and given emergency use authorization in India initiate mass vaccination January 2021. This study aimed investigate serious adverse events following immunizations (AEFIs) reported for vaccines identify predictors of mortality among these cases from India. A secondary data analysis was conducted on causality assessment reports 2708 AEFIs published by National AEFI Committee under Immunization Division, Ministry Health Family Welfare, Government The included all 21 up until May 2023. primary outcome variable analyzed survival/death status each case, with various covariates documents considered analysis. majority assessed either coincidental (1220, 45%) or undetermined/unclassifiable (781, 28.8%). recipients Covishield (1891, 69.8%) followed Covaxin (347, 12.8%). Among these, 1114 (42.1%) died while remaining 1594 (58.9%) hospitalized recovered. Systematically, involving cardiovascular system (696, 31.3%) most common, those affecting respiratory (288, 13%) neuropsychiatric (295, 13.3%) which had significant association age (p < 0.001) gender 0.001). On multivariable analysis, females = 0.001), younger groups whose determined classified gastrointestinal North Western occurring during winter season 0.05) significantly lower odds mortality. cohort reported, older age, male sex, undetermined unclassifiable classification, involvement associated higher require close monitoring vaccination.

Language: Английский

Citations

0
Response to: Van Wyk et al. letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’ DOI Creative Commons
Nicolas Hulscher,

Roger Hodkinson,

William Makis

et al.

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2476 - 2478

Published: May 21, 2024

We thank Van Wyk et al. for their concerns about fatal COVID-19 vaccine induced myocarditis.1 agree with that papers such as ours should have 'major implications the public's health and perception of vaccination.' emphasized importance covariate information. Because each included case presented a dataset, covariates to degree they were disclosed considered in adjudication process. present all available information Table 1, including any co-morbities studies presented. Adjudicators reviewed vignettes described original reports. found none comorbidities proximate cause death. In cases, autopsy findings revealed myocarditis was primary Myocarditis has been linked vaccination years by Centers Disease Control Prevention (CDC).2 When performing autopsies, possible aetiologies are investigated, final death is assigned based upon clinical judgement examiner(s). mentioned temporality poorly established five cases died within 2 days after vaccination, however, this timeframe consistent production Spike protein, cardiac inflammation, resultant lethal arrhythmias. Patone an increased risk 28-day window vaccination.3 often results sudden before other symptoms appear.4 Since time writing our publication, more evidence published supporting biological mechanisms myocarditis. Isolated vaccine-induced protein causing cardiovascular inflammation myocarditis5, 6 may not be only mechanism(s) damage. Krauson mRNA, accompanied histologically confirmed myocardial injury, hearts individuals 30 vaccination.7 Schreckenberg inoculated adult rat cardiomyocytes mRNA-1273 (Moderna) BNT162b2 (Pfizer) resulted cellular dysfunctions seen cardiomyopathy.8 Along mRNA resulting adjuvants play role heart damage Kanuri Sirrkay.9 al.'s point World Health Organization (WHO) criteria considered. It WHO adverse event following immunization (AEFI) methodology10 emphasizes documents, complete medical history, results. For individual assessment, process met AEFI standards. raised issue on population level. important but beyond scope manuscript. The US Food Drug Administration Center Biologics Evaluation Research (CBER) designated follow-up period 5 15 novel genetic products, vaccines, observe effects might emerge exposed over time.11 2024, paper published, largest safety study date, conducted Global Vaccine Data Network (GVDN), published.12 multi-country study, which approximately 99 million vaccinated individuals, researchers observed notably higher than expected vaccinations. Specifically, dose two from vaccines 6.10 2.86 times baseline rates, respectively.12 Rose analysed Adverse Event Reporting System (VAERS) number reports 2021 223 average combined past years, concluding strongly associated serious signal myocarditis, hospitalization death.13 recognized transparency literature search paper, Figure 1 fully numbers screened, reviewed, included. we unaware missed during review period. Pantazatos14 Aarstad15 discussion, because preprints vital disseminating while undergo months long peer-review process.16 Skidmore17 retracted violation Committee Publication Ethics (COPE) guidelines18 republished at another journal.19 estimate 709 740 result derived applying underreporting factor VAERS data, indeed extrapolation requires careful interpretation support highlighted. well main limitation underreporting,20, 21 written official guide interpreting data.22 estimated fewer 1% events reported VAERS.19 While there no factor, it approximated fall range 20–40.13, 14, 23 Thus, Pantazatos al.14 20 utilized well-supported conservative estimate. Meissner 86% completed professionals or manufacturers.24 Healthcare submitting provide comprehensive vignettes, identity contact thoroughly documented under penalty law false reporting. can inferred reliable CDC verification. Overall, since new provided further population-level associations between myocarditis.12, 13 Additionally, now deleterious components protein,5, mRNA7, 8 adjuvants.9 coworkers state, 'we believe fails appropriately evaluate communicate impact mortality', implicate complication even larger public future published. these comments conclusions strong call continued vigilance research aimed mitigating outcome vaccination. RH WM longer Wellness Company. PM receives salary (modest) equity Company, had manuscript correspondence.

Language: Английский

Citations

2