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. 2025 Feb 20;231(2):378-385.
doi: 10.1093/infdis/jiae502.

Effectiveness of the Original Monovalent Messenger RNA Coronavirus Disease 2019 (COVID-19) Vaccination Series Against Hospitalization for COVID-19-Associated Venous Thromboembolism

David N Hager  1 , Yuwei Zhu  2 , Ine Sohn  2 , William B Stubblefield  3 , Michael B Streiff  1 , Manjusha Gaglani  4 , Jay S Steingrub  5 , Abhijit Duggal  6 , Jamie R Felzer  7 , Mary O'Rourke  8 , Ithan D Peltan  9   10 , Amira Mohamed  11 , Robin Stiller  12 , Jennifer G Wilson  13 , Nida Qadir  14 , Adit A Ginde  15 , Anne E Zepeski  16 , Christopher Mallow  17 , Adam S Lauring  18 , Nicholas J Johnson  19 , Kevin W Gibbs  20 , Jennie H Kwon  21 , Wesley H Self  22 ; Investigating Respiratory Viruses in the Acutely Ill (IVY) Network
Collaborators, Affiliations

Effectiveness of the Original Monovalent Messenger RNA Coronavirus Disease 2019 (COVID-19) Vaccination Series Against Hospitalization for COVID-19-Associated Venous Thromboembolism

David N Hager et al. J Infect Dis. .

Abstract

Background: Coronavirus disease 2019 (COVID-19) is a strong risk factor for venous thromboembolism (VTE). Few studies have evaluated the effectiveness of COVID-19 vaccination in preventing hospitalization for COVID-19 with VTE.

Methods: Adults hospitalized at 21 sites between March 2021 and October 2022 with symptoms of acute respiratory illness were assessed for COVID-19, completion of the original monovalent messenger RNA (mRNA) COVID-19 vaccination series, and VTE. Prevalence of VTE was compared between unvaccinated and vaccinated patients with COVID-19. The vaccine effectiveness (VE) in preventing COVID-19 hospitalization with VTE was calculated using a test-negative design. The VE was also stratified by predominant circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant.

Results: Among 18 811 patients (median age [interquartile range], 63 [50-73] years; 49% women; 59% non-Hispanic white, 20% non-Hispanic black, and 14% Hispanic; and median of 2 comorbid conditions [interquartile range, 1-3]), 9792 were admitted with COVID-19 (44% vaccinated), and 9019 were test-negative controls (73% vaccinated). Among patients with COVID-19, 601 had VTE diagnosed by hospital day 28, of whom 170 were vaccinated. VTE was more common among unvaccinated than vaccinated patients with COVID-19 (7.8% vs 4.0%; P = .001). The VE against COVID-19 hospitalization with VTE was 84% overall (95% confidence interval, 80%-87%), and VE stratified by predominant circulating variant was 88% (73%-95%) for Alpha, 93% (90%-95%) for Delta, and 68% (58%-76%) for Omicron variants.

Conclusions: Vaccination with the original monovalent mRNA series was associated with a decrease in COVID-19 hospitalization with VTE, though data detailing prior history of VTE and use of anticoagulation were not available. These findings will inform risk-benefit considerations for those considering vaccination.

Keywords: COVID-19; SARS-CoV-2; vaccine; venous thromboembolism.

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Conflict of interest statement

Potential conflicts of interest . M. B. S. reports consulting fees from Bristol Myers Squibb, Janssen, Pfizer, CSL Behrin, and Attralus and honoraria from Bristol Myers Squibb, Janssen, and Pfizer, and he has participated on a data and safety monitoring board on behalf of CSL Behring. I. D. P. reports support from Janssen Pharmaceutical and institutional support from Bluejay Diagnostics and Regeneron. A. S. L. reports support from FluLab and Roche Pharmaceuticals. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Flow diagram of participants with acute respiratory illness (ARI). Data from participants in gray boxes are used to calculate the effectiveness of monovalent messenger RNA (mRNA) vaccination in preventing hospitalization for coronavirus disease 2019 (COVID-19) with venous thromboembolism (VTE).
Figure 2.
Figure 2.
Effectiveness of messenger RNA coronavirus disease 2019 (COVID-19) vaccination for the prevention of COVID-19 hospitalization with acute venous thromboembolism (VTE). Abbreviations: CI, confidence interval; VE, vaccine effectiveness.
See this image and copyright information in PMC

References

    1. Heit JA, Melton LJ III, Lohse CM, et al. Incidence of venous thromboembolism in hospitalized patients vs community residents. Mayo Clin Proc 2001; 76:1102–10. - PubMed
    1. Bilaloglu S, Aphinyanaphongs Y, Jones S, Iturrate E, Hochman J, Berger JS. Thrombosis in hospitalized patients with COVID-19 in a New York City health system. JAMA 2020; 324:799–801. - PMC - PubMed
    1. Helms J, Tacquard C, Severac F, et al. High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med 2020; 46:1089–98. - PMC - PubMed
    1. Klok FA, Kruip M, van der Meer NJM, et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: an updated analysis. Thromb Res 2020; 191:148–50. - PMC - PubMed
    1. Katsoularis I, Fonseca-Rodriguez O, Farrington P, et al. Risks of deep vein thrombosis, pulmonary embolism, and bleeding after COVID-19: nationwide self-controlled cases series and matched cohort study. BMJ 2022; 377:e069590. - PMC - PubMed

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