Association between BNT162b2 or CoronaVac COVID-19 vaccines and major adverse cardiovascular events among individuals with cardiovascular disease

Abstract

Aims Concern about the cardiovascular safety of coronavirus disease 2019 (COVID-19) vaccines among individuals with cardiovascular disease (CVD) may lead to vaccine hesitancy. We sought to assess the association between two COVID-19 vaccines, BNT162b2 and CoronaVac, and the risk of major adverse cardiovascular events (MACE) in individuals with established CVD. Methods and results We identified individuals with a history of CVD before 23 February 2021 and a diagnosis of MACE between 23 February 2021 and 31 January 2022 in Hong Kong. MACE was defined as a composite of myocardial infarction, stroke, revascularization, and cardiovascular death. Electronic health records from the Hong Kong Hospital Authority were linked to vaccination records from the Department of Health. A self-controlled case-series method was used to evaluate the risk of MACE for 0–13 and 14–27 days after two doses of COVID-19 vaccine. We estimated incidence rate ratios (IRRs) to compare the risk of MACE between each risk period and the baseline period. A total of 229 235 individuals with CVD were identified, of which 1764 were vaccinated and had a diagnosis of MACE during the observation period (BNT162b2 = 662; CoronaVac = 1102). For BNT162b2, IRRs were 0.48 [95% confidence interval (CI) 0.23–1.02] for the first dose and 0.87 (95% CI 0.50–1.52) for the second dose during the 0–13 days risk period, 0.40 (95% CI 0.18–0.93) for the first dose and 1.13 (95% CI 0.70–1.84) for the second dose during the 14–27 days risk period. For CoronaVac, the IRRs were 0.43 (95% CI 0.24–0.75) for the first dose and, 0.73 (95% CI 0.46–1.16) for the second dose during the 0–13 days risk period, 0.54 (95% CI 0.33–0.90) for the first dose and 0.83 (95% CI 0.54–1.29) for the second dose during the 14–27 days risk period. Consistent results were found in subgroup analyses for different sexes, age groups and different underlying cardiovascular conditions. Conclusion Our findings showed no evidence of an increased risk of MACE after vaccination with BNT162b2 or CoronaVac in patients with CVD. Future research is required to monitor the risk after the third dose of each vaccine.

Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study

“…However, a recent study reported that patients with previous history of major adverse cardiac events (MACE) are not at higher risk of further MACE after mRNA (BNT162b2) and inactivated (CoronaVac) vaccinations. 56 We also excluded cases with a positive SARS-CoV-2 test before and within the study period to minimize bias. Both hemorrhagic stroke and thromboembolic event cases such as ischemic stroke could potentially be an result from SARS-CoV-2 infection.…”

Safety of BNT162b2 or CoronaVac COVID-19 vaccines in patients with heart failure: a self-controlled case series study

“…The results further support that the risk of MACE following BNT162b2 and CoronaVac COVID-19 vaccines in patients with HF is very low and are consistent with our earlier study of patients with coronary heart disease, cerebrovascular disease, peripheral vascular disease or cardiovascular surgery where no increased risk of MACE was detected after receiving BNT162b2 or CoronaVac. 24 …”

“… 25 The methodology was developed for event-dependent exposures and outcome events with a high risk of short-term mortality and had also been applied to many high-quality COVID-19 vaccine safety studies. 21 , 22 , 23 , 24 Other strengths include using a number of sensitivity analyses to test the robustness of our results, including the risk of hospitalization for HF, MACE and all hospitalization as the study outcomes, and having both BNT162b2, a mRNA vaccine and CoronaVac, an inactivated vaccine in our analyses.…”

“…The SCCS is a within-individual study design that was developed to assess vaccine-related outcomes 20 and has been widely used for vaccine safety monitoring. 21 , 22 , 23 , 24 In SCCS analysis, an individual's observation period is fixed and follow-up is not censored at the event; hence all exposures occurring within the observation period, both before and after individuals have experienced the event, are included in the analysis. 20 The SCCS determines the relative incidence of the outcome by comparing the risks of outcome events between exposure and non-exposure baseline periods within the same individual ( Fig.…”

“… 25 The modified SCCS has been used in several high-quality studies on the association between COVID-19 vaccines and a series of outcomes. 21 , 22 , 23 , 24 , 25 Due to similar considerations, the use of modified SCCS and the inclusion of unvaccinated individuals are more appropriate for addressing our study objectives. Lastly, the occurrence of an event should not affect the subsequent period of observation.…”