J Korean Med Sci.  2021 Jul;36(27):e197. 10.3346/jkms.2021.36.e197.

Predicted and Observed Incidence of Thromboembolic Events among Koreans Vaccinated with ChAdOx1 nCoV-19 Vaccine

• Huh K
• Na Y
• Kim YE
• Radnaabaatar M
• Peck KR
• Jung J

• KMID: 2518355
• DOI: http://doi.org/10.3346/jkms.2021.36.e197

Abstract

We used the nationwide claims database to calculate the incidence of thrombotic events and predict their overall 2-week incidence. From 2006 to 2020, the incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC) tended to increase. Unlike intracranial venous thrombosis (ICVT) and intracranial thrombophlebitis (ICTP), which showed no age difference, other venous embolism, and thrombosis (OVET), DIC, DVT, and PE were significantly more common in over 65 years. The overall 2-week incidence of ICVT was 0.21/1,000,000 (95% confidence interval [CI], 0.11–0.32). ICTP, OVET, DIC, DVT and PE were expected to occur in 0.08 (95% CI, 0.02– 0.14), 7.66 (95% CI, 6.08–9.23), 5.95 (95% CI, 4.88–7.03), 13.28 (95% CI, 11.92–14.64), 14.09 (95% CI, 12.80–15.37) per 1,000,000, respectively. To date, of 8,548,231 patients vaccinated with ChAdOx1 nCoV-19 in Korea, two had confirmed thrombosis with thrombocytopenia syndrome within 2 weeks. The observed incidence of ICVT after vaccination was 0.23/1,000,000.

Keyword

COVID-19; Thrombosis with Thrombocytopenia Syndrome; Vaccination; Vaccine Adverse Events

Figure

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  Fig. 1 Observed and predicted incidences of the study conditions. (A) DVT; (B) ICVT; (C) ICTP; (D) PE; (E) OVET; (F) DIC.DIC = disseminated intravascular coagulation, DVT = deep vein thrombosis, ICTP = intracranial thrombophlebitis, ICVT = intracranial venous thrombosis, PE = pulmonary embolism, OVET = other venous embolism, and thrombosis.

Reference

1. Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination. N Engl J Med. 2021; 384(22):2092–2101. PMID: 33835769.

2. Dotan A, Shoenfeld Y. Perspectives on vaccine induced thrombotic thrombocytopenia. J Autoimmun. 2021; 121:102663. PMID: 34020254.

3. Muir KL, Kallam A, Koepsell SA, Gundabolu K. Thrombotic thrombocytopenia after Ad26.COV2.S vaccination. N Engl J Med. 2021; 384(20):1964–1965. PMID: 33852795.

4. Yocum A, Simon EL. Thrombotic thrombocytopenic purpura after Ad26.COV2-S vaccination. Am J Emerg Med. Forthcoming 2021. DOI: 10.1016/j.ajem.2021.05.001.

5. European Medicines Agency. AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. Updated 2021. Accessed May 31, 2021. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood.

6. European Medicines Agency. COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues. Updated 2021. Accessed May 31, 2021. https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-assessment-very-rare-cases-unusual-blood-clots-low-platelets-continues.

7. Baker MA, Nguyen M, Cole DV, Lee GM, Lieu TA. Post-licensure rapid immunization safety monitoring program (PRISM) data characterization. Vaccine. 2013; 31(Suppl 10):K98–112. PMID: 24331080.

8. Korea Disease Control and Prevention Agency. Press release (6.16). Updated 2021. Accessed June 16, 2021. http://www.kdca.go.kr/board/board.es?mid=a20501000000&bid=0015&list_no=713681&act=view.

9. Coutinho JM, Zuurbier SM, Aramideh M, Stam J. The incidence of cerebral venous thrombosis: a cross-sectional study. Stroke. 2012; 43(12):3375–3377. PMID: 22996960.

10. Devasagayam S, Wyatt B, Leyden J, Kleinig T. cerebral venous sinus thrombosis incidence is higher than previously thought: a retrospective population-based study. Stroke. 2016; 47(9):2180–2182. PMID: 27435401.

11. Fairbanks A, Chodnicki K, Lesser E, Hodge D, Leavitt J, Garrity J, et al. Population-based incidence and visual outcomes of cerebral venous sinus thrombosis. ARVO Annual Meeting Abstract. Rockville, MD: Association for Research in Vision and Ophthalmology;2018.

12. Jacob J, Klamroth R, Ploner T, Harder T, Koch J, Wichmann O, et al. Incidence of cerebral venous sinus thrombosis in adults in Germany – a retrospective study using health claims data. Res Sq. Forthcoming 2021. DOI: 10.21203/rs.3.rs-428469/v2.

13. Huh K, Kim YE, Radnaabaatar M, Lee DH, Kim DW, Shin SA, et al. Estimating baseline incidence of conditions potentially associated with vaccine adverse events: a call for surveillance system using the Korean National Health Insurance claims data. J Korean Med Sci. 2021; 36(9):e67. PMID: 33686812.