Effectiveness of the original monovalent mRNA COVID-19 vaccination series against hospitalization for COVID-19-associated venous thromboembolism

David N Hager; Yuwei Zhu; Ine Sohn; William B Stubblefield; Michael B Streiff; Manjusha Gaglani; Jay S Steingrub; Abhijit Duggal; Jamie R Felzer; Mary O'Rourke; Ithan D Peltan; Amira Mohamed; Robin Stiller; Jennifer G Wilson; Nida Qadir; Adit A Ginde; Anne E Zepeski; Christopher Mallow; Adam S Lauring; Nicholas J Johnson; Kevin W Gibbs; Jennie H Kwon; Wesley H Self; Investigating Respiratory Viruses in the Acutely Ill (IVY) Network

doi:10.1093/infdis/jiae502

Effectiveness of the original monovalent mRNA COVID-19 vaccination series against hospitalization for COVID-19-associated venous thromboembolism

J Infect Dis. 2024 Oct 15:jiae502. doi: 10.1093/infdis/jiae502. Online ahead of print.

Authors

David N Hager¹, Yuwei Zhu², Ine Sohn², William B Stubblefield³, Michael B Streiff¹, Manjusha Gaglani⁴, Jay S Steingrub⁵, Abhijit Duggal⁶, Jamie R Felzer⁷, Mary O'Rourke⁸, Ithan D Peltan⁹, Amira Mohamed¹⁰, Robin Stiller¹¹, Jennifer G Wilson¹², Nida Qadir¹³, Adit A Ginde¹⁴, Anne E Zepeski¹⁵, Christopher Mallow¹⁶, Adam S Lauring¹⁷, Nicholas J Johnson¹⁸, Kevin W Gibbs¹⁹, Jennie H Kwon²⁰, Wesley H Self²¹; Investigating Respiratory Viruses in the Acutely Ill (IVY) Network

Collaborators

Investigating Respiratory Viruses in the Acutely Ill (IVY) Network:
Manjusha Gaglani, Tresa McNeal, Shekhar Ghamande, Nicole Calhoun, Kempapura Murthy, Judy Herrick, Amanda McKillop, Eric Hoffman, Martha Zayed, Michael Smith, Jay Steingrub, Lori-Ann Kozikowski, Lesley De Souza, Scott Ouellette, Nathan I Shapiro, Michael Bolstad, Brianna Coviello, Robert Ciottone, Arnaldo Devilla, Ana Grafals, Conor Higgins, Carlo Ottanelli, Kimberly Redman, Douglas Scaffidi, Alexander Weingart, Diya Surie, Meredith McMorrow, Jennifer DeCuir, Natalie Thornburg, Brendan Flannery, Nathaniel Lewis, Mark Tenforde, Katherine Adams, Manish Patel, Omar Mehkri, Megan Mitchell, Zachary Griffith, Connery Brennan, Kiran Ashok, Bryan Poynter, Abhijit Duggal, Laurence Busse, Caitlin Ten Lohuis, Nicholas Stanley, Sophia Zhang, Matthew Prekker, Heidi Erickson, Anne Frosch, Audrey Hendrickson, Sean Caspers, Walker Tordsen, Olivia Kaus, Tyler Scharber, Ithan Peltan, Samuel Brown, Jenna Lumpkin, Cassie Smith, Hunter Marshall, David N Hager, Harith Ali, Michelle Gong, Amira Mohamed, Rahul Nair, Jen-Ting Tina Chen, Matthew Exline, Sarah Karow, Emily Robart, Paulo Nunes Maldonado, Maryiam Khan, Preston So, Madison So, Elizabeth Schwartz, Mena Botros, Akram Khan, Catherine L Hough, Haeun Jung, Jesus Martinez, Andrea Luong, Bao Huynh, Habiba Ibrahim, Cynthia Villanueva-Vargas, Juliana Villanueva-Vargas, Suha Quadri, Jennifer G Wilson, Alexandra June Gordon, Joe Levitt, Cynthia Perez, Anita Visweswaran, Jonasel Roque, Nida Qadir, Steven Chang, Trevor Frankel, Omai Garner, Sukantha Chandrasekaran, Adit Ginde, David Douin, Kelly Jensen, David Huynh, Aimee Steinwand, Cori Withers, Nicholas Mohr, Anne Zepeski, Paul Nassar, Shannon Landers, Karin Nielsen, Noble Briggs, Cathy Fairfield, Chris Mallow, Carolina Rivas, Emily Martin, Arnold Monto, Adam Lauring, E J McSpadden, Rachel Truscon, Anne Kaniclides, Lara Thomas, Ramsay Bielak, Weronika Damek Valvano, Rebecca Fong, William J Fitzsimmons, Christopher Blair, Julie Gilbert, Leigh Papalambros, Nicholas Johnson, Vasisht Srinivasan, Christine D Crider, Kyle A Steinbock, Thomas C Paulsen, Layla A Anderson, Wesley H Self, H Keipp Talbot, Carlos Grijalva, Ian Jones, Natasha Halasa, James Chappell, Kelsey Womack, Jillian Rhoads, Adrienne Baughman, Christy Kampe, Jakea Johnson, Kim Hart, Todd Rice, Jonathan Casey, William B Stubblefield, Yuwei Zhu, Laura L Short, Lauren J Ezzell, Margaret E Whitsett, Rendie E McHenry, Samarian J Hargrave, Marcia Blair, Jennifer L Luther, Claudia Guevara Pulido, Bryan P M Peterson, D Clark Files, Kevin Gibbs, Mary LaRose, Leigha Landreth, Madeline Hicks, Lisa Parks, Hilary Babcock, Jennie Kwon, Jahnavi Bongu, David McDonald, Candice Cass, Sondra Seiler, David Park, Tiffany Hink, Meghan Wallace, Carey-Ann Burnham, Olivia G Arter

Affiliations

¹ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
² Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³ Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁴ Baylor Scott and White Health, Baylor College of Medicine - Temple, Texas A&M University College of, Medicine, Temple, Texas, USA.
⁵ Department of Medicine, Baystate Medical Center, Springfield, Massachusetts, USA.
⁶ Department of Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
⁷ Department of Medicine, Emory University, Atlanta, Georgia, USA.
⁸ Department of Emergency Medicine and Medicine, Hennepin County Medical Center, Minneapolis, , Minnesota, USA.
⁹ Department of Medicine, Intermountain Medical Center, Murray, Utah and University of Utah, Salt Lake City, Utah, USA.
¹⁰ Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
¹¹ Division of Pulmonary, Allergy and Critical Care Medicine, Oregon Health and Sciences University, Portland, Oregon, USA.
¹² Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.
¹³ Department of Medicine, University of California-Los Angeles, Los Angeles, California, USA.
¹⁴ Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
¹⁵ Department of Emergency Medicine, University of Iowa, Iowa City, Iowa, USA.
¹⁶ Department of Medicine, University of Miami, Miami, Florida, USA.
¹⁷ Departments of Internal Medicine and Microbiology and Immunology, University of Michigan, Ann Arbor, Michigan, USA.
¹⁸ Department of Emergency Medicine and Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA.
¹⁹ Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
²⁰ Department of Medicine, Washington University, St. Louis, Missouri, USA.
²¹ Department of Emergency Medicine and Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

PMID: 39405261
DOI: 10.1093/infdis/jiae502

Abstract

Background: 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 mRNA COVID-19 vaccination series, and VTE. Prevalence of VTE was compared between unvaccinated and vaccinated patients with COVID-19. Vaccine effectiveness in preventing COVID-19 hospitalization with VTE was calculated using a test negative design. Vaccine effectiveness was also stratified by predominant circulating SARS-CoV-2 variant.

Results: Among 18,811 patients (median age 63 [IQR:50-73], 49% women, 59% non-Hispanic White, 20% non-Hispanic Black, 14% Hispanic, and median of 2 comorbid conditions [IQR:1-3]), 9,792 were admitted with COVID-19 (44% vaccinated) and 9,019 were test-negative controls (73% vaccinated). Among patients with COVID-19, 601 were diagnosed with VTE by hospital day 28, of whom 170 were vaccinated. VTE was more common among unvaccinated than vaccinated COVID-19 patients (7.8% versus 4.0%; p=0.001). Vaccine effectiveness against COVID-19 hospitalization with VTE was 84% (95% CI: 80-87%) overall. Vaccine effectiveness stratified by predominant circulating variant was 88% (73-95%) for alpha, 93% (90-95%) for delta, and 68% (58-76%) for omicron variants.

Conclusions and relevance: 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; deep venous thrombosis; pulmonary embolus; vaccine; venous thromboembolism.

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