"Methods: ... Employees of the University Hospital Basel, Switzerland, scheduled to receive mRNA-1273 first booster vaccination, and who provided written informed consent, were offered active surveillance ... Major adverse cardiac events (MACE) including acute heart failure, cardiac death, life-threatening arrhythmia and acute myocardial infarction (AMI) were assessed at 30-day follow-up ...
Discussion: This prospective investigator-initiated, industry-independent study was performed to test the hypothesis that mRNA-1273 booster vaccination-associated myocardial injury may be more common than currently thought as symptoms may be unspecific, mild or even absent, escaping passive surveillance detecting only hospitalized cases. We report four main findings.
First, our findings confirmed the study hypothesis. mRNA-1273 booster vaccination-associated elevation of markers of myocardial injury occurred in about one out of 35 persons (2.8%), a greater incidence than estimated in meta-analyses of hospitalized cases with myocarditis... Second, all cases were mild with only a transient and short period of myocardial injury... Third, when using sex-specific ULN cut-offs for myocardial injury adjudication, mRNA-1273 booster vaccine-associated myocardial injury occurred significantly more often in women versus men (3.7% vs. 0.8%). This is in striking discrepancy to the sex distribution of vaccine-associated myocardial injury in the setting of clinical myocarditis following the first and second vaccinations detected by passive surveillance, which occurred predominately in young men. Median age of participants developing mRNA-1273 vaccine-associated myocardial injury was 46 years. Thereby, also the age distribution is different to that of most reported vaccine-associated clinical myocarditis cases... The significantly higher rate of mRNA-1273 booster vaccination-associated myocardial injury in women versus men may at least partly be related to the higher vaccine dose per body weight or myocardial mass in women and therefore dose-dependent toxic effects"
© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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