Determinants of COVID-19 vaccine-induced myocarditis

Abstract

Background: Following the roll-out of the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in the United States, millions of individuals have reported adverse events (AEs) using the vaccine adverse events reports system (VAERS). The objective of this analysis is to describe the myocarditis data in VAERS and the COVID-19 vaccines as potential determinants of myocarditis. Methods: We used VAERS data to examine the frequency of reporting myocarditis since the beginning of the mass vaccination campaign and compared this with historical values in VAERS and COVID-19 vaccine administration data from the Our World in Data database. We examined myocarditis reports in VAERS in the context of sex, age, and dose. Statistical analysis was done using the Student’s t-test to determine statistically significant differences between ages among myocarditis adverse events (AEs) and the chi-square test to determine relationships between categorical variables with statistical significance. Results: We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years. This represented a 2500% increase in the absolute number of reports in the first year of the campaign when comparing historical values prior to 2021. Demographic data revealed that myocarditis occurred most in youths (50%) and males (69%). A total of 76% of cases resulted in emergency care and hospitalization. Of the total myocarditis reports, 92 individuals died (3%). Myocarditis was more likely after dose 2 ( p < 0.00001) and individuals less than 30 years of age were more likely than individuals older than 30 to acquire myocarditis ( p < 0.00001). Conclusion: COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death. Further investigation into the underlying mechanisms of COVID-19 vaccine-induced myocarditis is imperative to create effective mitigation strategies and ensure the safety of COVID-19 vaccination programs across populations.

Ethics of Nudging in the COVID-19 Crisis and the Necessary Return to the Principles of Shared Decision Making: A Critical Review

“…The authors state that the aim is to present information in a neutral way, so it should also be mentioned that COVID-19 is a disease that primarily affects vulnerable people, especially the elderly. Given the side-effects of the vaccines [25], the risk-benefit ratio appears to be not acceptable especially for younger age groups who predominantly have a mild course and a low infection fatality rate [158]. Instead, the goal is to reduce "vaccine hesitancy" and the authors even talk about SDM being helpful in the context of motivational interviewing if COVID-19 vaccination may one day be mandatory.…”

“…The authors then refer to the uptake of COVID-19 vaccines and even mention the serious side effects of blood clots, which might even increase vaccine hesitancy if patients were not given information weighing these risks against the risk of contracting the virus. If SDM delivers evidence-based, trustworthy information, then people should be informed that COVID-19 is mainly a disease that predominantly affects older people and/or is a serious disease for those with major complications and that the vaccines may have serious adverse effects [23][24][25][160][161][162][163]. Therefore, the aim of SDM should not be to promote a mass vaccination campaign in COVID-19 as this would be unethical in the light of the massive risk differences in different age and morbidity groups [158,164].…”

“…Alternative drug treatments were defamed from the beginning. AstraZeneca's vaccine was withdrawn from the German market at the end of 2021 (see [16,24,25,257,258]). This can also be regarded as incorrect (see, for example, [16,24,25,257,258]).…”

“…In this article, we outline the use of nudges in pandemic management [14], give a detailed account of the suggestions of the German COVID-19 Snapshot Monitoring (COSMO) study and their influence on the pandemic-related policy in Germany and argue that the non-evidence-based use of nudging to manage a global pandemic may have led to unintended yet serious socio-economic, psychological, and health problems, and societal consequences and is thus incompatible with the ethical standards of health and public management. In that regard, it is important to mention that all measures taken by governments to contain COVID-19 are discussed controversially in the literature and their evidence base is more than unclear, and further similar results are still being published [15][16][17][18][19][20][21][22][23][24][25][26][27]. As the side effects of using nudges in the pandemic management probably led to serious consequences, which will be described in the following sections, we ask for a debriefing of the nudgee.…”

Excess Cardiopulmonary Arrest and Mortality after COVID-19 Vaccination in King County, Washington

“…The primary vaccine platform utilized in the US is messenger RNA (mRNA) in lipid nanoparticles (LNPs) used by Pfizer/BioNTech (BNT162b1) and Moderna (mRNA-1273), followed by the viral vector platform used by Johnson & Johnson (Ad26.CoV2.S) [1]. COVID-19 vaccines have since been linked to several cardiovascular adverse events such as myocarditis [2][3][4], myocardial infarction [5][6][7], and venous thromboembolisms [8][9][10]. This has led to concerns of a possible relationship between vaccination rates and increased rates of cardiopulmonary incidents.…”