Cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis.

ABSTRACT

OBJECTIVES: To evaluate the cardiovascular safety of COVID-19 vaccines in the real world. METHODS: Studies reported on any COVID-19 vaccine-related cardiovascular events in the population aged ≥12 years between 1 January 2020 and 15 June 2022 were included. RESULTS: A total of 42 studies were included in this meta-analysis. Myocarditis risk was mainly seen after the second (risk ratio [RR], 2.09; 95% confidence interval [CI] 1.59-2.58) and third (RR, 2.02; 95% CI 1.04-2.91) dose. A total of 5 vaccines were analyzed, among which mRNA-1273 (RR, 3.13; 95% CI 2.11-4.14) and BNT162b2 (RR, 1.57; 95% CI 1.30-1.85) vaccines were associated with myocarditis risk. No significant increase in risk of myocardial infarction (RR, 0.96) or arrhythmia (RR, 0.98) events was observed following vaccination. The risk of cardiovascular events (myocarditis, RR, 8.53; myocardial infarction, RR, 2.59; arrhythmia, RR, 4.47) after SARS-CoV-2 infection was much higher than after vaccination. CONCLUSIONS: The risk of myocarditis was observed after COVID-19 vaccination, but it was much lower than that following the SARS-CoV-2 infection. No significant increased risk of myocardial infarction or arrhythmia was found after COVID-19 vaccination.