J Korean Med Sci.  2024 Jun;39(24):e190. 10.3346/jkms.2024.39.e190.

Cardiovascular Safety of COVID-19 Vaccination in Patients With Cancer: A Self-Controlled Case Series Study in Korea

Affiliations
  • 1School of Pharmacy, Sungkyunkwan University, Suwon, Korea
  • 2Department of Development, SK Bioscience, Seongnam, Korea
  • 3Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA
  • 4Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea
  • 5Department of Neurology, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea
  • 6Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea

Abstract

Background
Cancer patients have an increased risk of cardiovascular outcomes and are susceptible to coronavirus disease 2019 (COVID-19) infection. We aimed to assess the cardiovascular safety of COVID-19 vaccination for cancer patients in South Korea.
Methods
We conducted a self-controlled case series study using the K-COV-N cohort (2018– 2021). Patients with cancer aged 12 years or older who experienced cardiovascular outcomes were identified. Cardiovascular outcomes were defined as myocardial infarction, stroke, venous thromboembolism (VTE), myocarditis, or pericarditis, and the risk period was 0–28 days after receiving each dose of COVID-19 vaccines. A conditional Poisson regression model was used to calculate the incidence rate ratio (IRR) with 95% confidence interval (CI).
Results
Among 318,105 patients with cancer, 4,754 patients with cardiovascular outcomes were included. The overall cardiovascular risk was not increased (adjusted IRR, 0.99 [95% CI, 0.90–1.08]) during the whole risk period. The adjusted IRRs of total cardiovascular outcomes during the whole risk period according to the vaccine type were 1.07 (95% CI, 0.95–1.21) in the mRNA vaccine subgroup, 0.99 (95% CI, 0.83–1.19) in the ChAdOx1 nCoV-19 vaccine subgroup, and 0.86 (95% CI, 0.68–1.10) in the mix-matched vaccination subgroup. However, in the analysis of individual outcome, the adjusted IRR of myocarditis was increased to 11.71 (95% CI, 5.88–23.35) during the whole risk period. In contrast, no increased risk was observed for other outcomes, such as myocardial infarction, stroke, VTE, and pericarditis.
Conclusion
For cancer patients, COVID-19 vaccination demonstrated an overall safe profile in terms of cardiovascular outcomes. However, caution is required as an increased risk of myocarditis following COVID-19 vaccination was observed in this study.

Keyword

Cancer; Cardiovascular Risk; COVID-19; Vaccine; Self-controlled Case Series

Figure

  • Fig. 1 Illustration of study design for the self-controlled case series analysis.

  • Fig. 2 Flow chart of study population selection.KDCA = Korea Disease Control and Prevention Agency, NHIS = National Health Insurance Service, VTE = venous thromboembolism, CV = cardiovascular.

  • Fig. 3 Risk of cardiovascular events following coronavirus disease 2019 vaccination among patients with cancer: subgroup analyses by vaccine types.VTE = venous thromboembolism, CV = cardiovascular, IRR = incidence rate ratio.


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