Key result
COVID-19 vaccination was associated with an increased risk of myocarditis (RR 1.39) compared to no vaccination, though the risk remained substantially lower than that following SARS-CoV-2 infection.
Why the study?
To assess the association between COVID-19 vaccines and the risk of major adverse cardiovascular events in the real world and provide an evidence-based basis for vaccine cardiovascular safety.
Does COVID-19 vaccination increase the risk of major adverse cardiovascular events in the general population?
Meta-Analysis (n=1,604,254,833)
Does COVID-19 vaccination increase the risk of major adverse cardiovascular events in the general population?
Relative Risk: 1.39 (95% CI 1.13–1.65)
While COVID-19 vaccination carries a small increased risk of myocarditis, particularly with mRNA vaccines in young males, the cardiovascular risks following SARS-CoV-2 infection are substantially higher, supporting the overall cardiovascular safety and benefit of vaccination.
Supports vaccination despite myocarditis signal; extends comparative safety data versus infection.
Aims To assess the association between COVID-19 vaccines and the risk of major adverse cardiovascular events (MACE) in the real world and to provide a reliable evidence-based basis for the cardiovascular safety of COVID-19 vaccines. Methods We conducted a comprehensive search in databases from January 1, 2020 to June 15, 2022 for observational studies, that included reporting of MACE and COVID-19 vaccines were included. Random-effects or fixed-effects models were used to estimate the pooled incidence rate and risk ratio of MACE after vaccination. Meta-regression, subgroup analyses, publication bias, sensitivity analyses were performed to evaluate the process and quality of meta-analysis. Results The analyses included data from 43 studies reporting of 16,978 cases, 28,451 cases, and 96,269 cases of myocarditis, myocardial infarction, and cardiac arrhythmia, respectively. The overall incidence rate was 14.8 events per million persons of myocarditis, and 1.73 and 9.6 events per 10,000 persons of myocardial infarction and cardiac arrhythmia after COVID-19 vaccination, respectively. Overall and subgroup analyses showed the increased risks of myocarditis associated with second dose (RR, 2.09; 95%CI: 1.59-2.58), third dose (RR, 2.02; 95%CI: 1.40-2.91), mRNA-1273 (RR, 3.13; 95%CI: 2.11-4.14), or BNT162b2 (RR, 1.57; 95%CI: 1.30-1.85) vaccination. The risk ratios of myocarditis events were more frequently in males than in females (3.44, 2.61-4.54), in younger than in older (2.20, 1.06-4.55). No significant increase risk of myocardial infarction (RR, 0.96; 95%CI: 0.84-1.08) or cardiac arrhythmia (RR, 0.98; 95%CI: 0.84-1.12) events was observed following vaccination. The risk of cardiovascular events (myocarditis, RR, 8.53; myocardial infarction, RR, 2.59; cardiac arrhythmia, RR, 4.47) after SARS-CoV-2 infection was much higher than after vaccination. Conclusion Although there is a risk of cardiovascular events following vaccination, the risk was much lower than that following SARS-CoV-2 infection. The benefits of COVID-19 vaccination to the population outweigh the risks in terms of cardiovascular safety assessment.
No takes yet. Share an insight, caveat, or question.
Chang et al. (2022) conducted a meta-analysis in COVID-19 vaccination (n=1,604,254,833). COVID-19 vaccines vs. Unvaccinated was evaluated on Myocarditis (RR 1.39, 95% CI 1.13-1.65). COVID-19 vaccination was associated with an increased risk of myocarditis (RR 1.39) compared to no vaccination, though the risk remained substantially lower than that following SARS-CoV-2 infection.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: