Effectiveness of Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Hospitalization and Severe In-Hospital Outcomes Among Adults in the United States, September 2022-August 2023

Jennifer DeCuir¹, Diya Surie¹, Yuwei Zhu², Adam S Lauring³, Manjusha Gaglani⁴, Tresa McNeal⁵, Shekhar Ghamande⁵, Ithan D Peltan⁶, Samuel M Brown⁶, Adit A Ginde⁷, Aimee Steinwand⁷, Nicholas M Mohr⁸, Kevin W Gibbs⁹, David N Hager¹⁰, Harith Ali¹⁰, Anne Frosch¹¹, Michelle N Gong¹², Amira Mohamed¹², Nicholas J Johnson¹³, Vasisht Srinivasan¹⁴, Jay S Steingrub¹⁵, Akram Khan¹⁶, Laurence W Busse¹⁷, Abhijit Duggal¹⁸, Jennifer G Wilson¹⁹, Nida Qadir²⁰, Steven Y Chang²⁰, Christopher Mallow²¹, Jennie H Kwon²², Matthew C Exline²³, Nathan I Shapiro²⁴, Cristie Columbus²⁵, Ivana A Vaughn²⁶, Mayur Ramesh²⁷, Basmah Safdar²⁸, Jarrod M Mosier²⁹, Jonathan D Casey³⁰, H Keipp Talbot³¹, Todd W Rice³⁰, Natasha Halasa³², James D Chappell³², Carlos G Grijalva³³, Adrienne Baughman³⁴, Kelsey N Womack³⁵, Jillian P Rhoads³⁵, Sydney A Swan², Cassandra Johnson², Nathaniel Lewis¹, Sascha Ellington¹, Fatimah S Dawood¹, Meredith McMorrow¹, Wesley H Self³⁶; Investigating Respiratory Viruses in the Acutely Ill (IVY) Network

Affiliations

¹ National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
² Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³ Departments of Internal Medicine and Microbiology and Immunology, University of Michigan, Ann Arbor, Michigan, USA.
⁴ Baylor College of Medicine, Baylor Scott & White Health, Temple and Dallas, Texas, Temple, Texas, USA.
⁵ Baylor College of Medicine, Baylor, Scott & White Health, Temple, Texas, USA.
⁶ Department of Pulmonary/Critical Care Medicine, Intermountain Medical Center, Murray, Utah and University of Utah, Salt Lake City, Utah, USA.
⁷ Department of Emergency Medicine, University of Colorado School of Medicine, Colorado, Aurora, USA.
⁸ Departments of Emergency Medicine, Anesthesia Critical Care, and Epidemiology, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.
⁹ Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
¹⁰ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Department of Emergency Medicine, Hennepin Healthcare Research Institute, Hennepin Healthcare System, Minneapolis, Minnesota, USA.
¹² Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
¹³ Department of Emergency Medicine and Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA.
¹⁴ Department of Emergency Medicine, University of Washington, Seattle, Washington, USA.
¹⁵ Department of Medicine, Baystate Medical Center, Springfield, Massachusetts, USA.
¹⁶ Department of Medicine, Oregon Health and Sciences University, Portland, Oregon, USA.
¹⁷ Department of Medicine, Emory University, Atlanta, Georgia, USA.
¹⁸ Department of Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁹ Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.
²⁰ Department of Medicine, University of California-Los Angeles, Los Angeles, California, USA.
²¹ Department of Medicine, University of Miami, Miami, Florida, USA.
²² Department of Medicine, Washington University, St. Louis, Missouri, USA.
²³ Department of Medicine, The Ohio State University, Columbus, Ohio, USA.
²⁴ Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
²⁵ Baylor, Scott & White Health, Texas A&M University College of Medicine, Dallas, Texas, USA.
²⁶ Department of Public Health Sciences, Henry Ford Health, Detroit, Michigan, USA.
²⁷ Division of Infectious Diseases, Henry Ford Health, Detroit, Michigan, USA.
²⁸ Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
²⁹ Department of Emergency Medicine, University of Arizona, Tucson, Arizona, USA.
³⁰ Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³¹ Departments of Medicine and Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³² Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³³ Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁴ Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁵ Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁶ Vanderbilt Institute for Clinical and Translational Research and Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

PMID: 39496339
PMCID: PMC11534416
DOI: 10.1111/irv.70027

Effectiveness of Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Hospitalization and Severe In-Hospital Outcomes Among Adults in the United States, September 2022-August 2023

Jennifer DeCuir et al. Influenza Other Respir Viruses. 2024 Nov.

. 2024 Nov;18(11):e70027.

doi: 10.1111/irv.70027.

Authors

Affiliations

¹ National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
² Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³ Departments of Internal Medicine and Microbiology and Immunology, University of Michigan, Ann Arbor, Michigan, USA.
⁴ Baylor College of Medicine, Baylor Scott & White Health, Temple and Dallas, Texas, Temple, Texas, USA.
⁵ Baylor College of Medicine, Baylor, Scott & White Health, Temple, Texas, USA.
⁶ Department of Pulmonary/Critical Care Medicine, Intermountain Medical Center, Murray, Utah and University of Utah, Salt Lake City, Utah, USA.
⁷ Department of Emergency Medicine, University of Colorado School of Medicine, Colorado, Aurora, USA.
⁸ Departments of Emergency Medicine, Anesthesia Critical Care, and Epidemiology, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.
⁹ Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
¹⁰ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Department of Emergency Medicine, Hennepin Healthcare Research Institute, Hennepin Healthcare System, Minneapolis, Minnesota, USA.
¹² Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
¹³ Department of Emergency Medicine and Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA.
¹⁴ Department of Emergency Medicine, University of Washington, Seattle, Washington, USA.
¹⁵ Department of Medicine, Baystate Medical Center, Springfield, Massachusetts, USA.
¹⁶ Department of Medicine, Oregon Health and Sciences University, Portland, Oregon, USA.
¹⁷ Department of Medicine, Emory University, Atlanta, Georgia, USA.
¹⁸ Department of Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁹ Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.
²⁰ Department of Medicine, University of California-Los Angeles, Los Angeles, California, USA.
²¹ Department of Medicine, University of Miami, Miami, Florida, USA.
²² Department of Medicine, Washington University, St. Louis, Missouri, USA.
²³ Department of Medicine, The Ohio State University, Columbus, Ohio, USA.
²⁴ Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
²⁵ Baylor, Scott & White Health, Texas A&M University College of Medicine, Dallas, Texas, USA.
²⁶ Department of Public Health Sciences, Henry Ford Health, Detroit, Michigan, USA.
²⁷ Division of Infectious Diseases, Henry Ford Health, Detroit, Michigan, USA.
²⁸ Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
²⁹ Department of Emergency Medicine, University of Arizona, Tucson, Arizona, USA.
³⁰ Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³¹ Departments of Medicine and Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³² Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³³ Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁴ Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁵ Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³⁶ Vanderbilt Institute for Clinical and Translational Research and Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

PMID: 39496339
PMCID: PMC11534416
DOI: 10.1111/irv.70027

Abstract

Background: Assessments of COVID-19 vaccine effectiveness are needed to monitor the protection provided by updated vaccines against severe COVID-19. We evaluated the effectiveness of original monovalent and bivalent (ancestral strain and Omicron BA.4/5) COVID-19 vaccination against COVID-19-associated hospitalization and severe in-hospital outcomes.

Methods: During September 8, 2022 to August 31, 2023, adults aged ≥ 18 years hospitalized with COVID-19-like illness were enrolled at 26 hospitals in 20 US states. Using a test-negative case-control design, we estimated vaccine effectiveness (VE) with multivariable logistic regression adjusted for age, sex, race/ethnicity, admission date, and geographic region.

Results: Among 7028 patients, 2924 (41.6%) were COVID-19 case patients, and 4104 (58.4%) were control patients. Compared to unvaccinated patients, absolute VE against COVID-19-associated hospitalization was 6% (-7%-17%) for original monovalent doses only (median time since last dose [IQR] = 421 days [304-571]), 52% (39%-61%) for a bivalent dose received 7-89 days earlier, and 13% (-10%-31%) for a bivalent dose received 90-179 days earlier. Absolute VE against COVID-19-associated invasive mechanical ventilation or death was 51% (34%-63%) for original monovalent doses only, 61% (35%-77%) for a bivalent dose received 7-89 days earlier, and 50% (11%-71%) for a bivalent dose received 90-179 days earlier.

Conclusion: Bivalent vaccination provided protection against COVID-19-associated hospitalization and severe in-hospital outcomes within 3 months of receipt, followed by a decline in protection to a level similar to that remaining from previous original monovalent vaccination by 3-6 months. These results underscore the benefit of remaining up to date with recommended COVID-19 vaccines.

Keywords: COVID‐19; COVID‐19 vaccines; United States; adult; hospitalization.

Published 2024. This article is a U.S. Government work and is in the public domain in the USA. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.

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Conflict of interest statement

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Samuel Brown reports that ReddyPort pays royalties for a patent, outside the submitted work. Steven Chang reports consulting fees from PureTech Health and Kiniksa Pharmaceuticals, outside the submitted work. Abhijit Duggal reports participating on an advisory board for ALung Technologies, outside the submitted work. Manjusha Gaglani reports grants from CDC, CDC‐Abt Associates, CDC‐Westat, and served as co‐chair of the Infectious Diseases and Immunization Committee for the Texas Pediatric Society (TPS) and received an honorarium serving as a TPS Project Firstline webinar speaker panelist for “Respiratory Virus Review: Clinical Considerations and IPC Guidance,” outside the submitted work. Michelle N. Gong reports a grant from NHLBI and CDC, fees for serving on Scientific Advisory Panel for Philips Healthcare, travel to ATS conference as board member, outside the submitted work. Carlos Grijalva reports grants from NIH, CDC, AHRQ, FDA, and Syneos Health and receipt of compensation for participation in an advisory board for Merck, outside the submitted work. Natasha Halasa reports receiving grants from Sanofi, Merck, and Quidel, outside the submitted work. Adam Lauring reports receiving grants from CDC, FluLab, NIH/National Institute of Allergy and Infectious Diseases, Burroughs Wellcome Fund, and MDHHS and consulting fees from Roche related to baloxavir, outside the submitted work. Christopher Mallow reports Medical Legal Consulting, outside the submitted work. Ithan D. Peltan reports grants from NIH and Janssen Pharmaceuticals and institutional support Regeneron, outside the submitted work. Mayur Ramesh reports participating in a non‐branded Speaker Program supported by AstraZeneca and MD Briefcase and participating on an advisory board for Moderna, Pfizer, and Ferring, outside the submitted work. No other potential conflicts of interest were disclosed.

Figures

**FIGURE 1**
Absolute COVID‐19 vaccine effectiveness against COVID‐19‐associated hospitalization among adults in the United States during September 8, 2022–August 31, 2023, including effectiveness of original monovalent vaccines only, bivalent mRNA vaccines received 7–89 days before illness onset, and bivalent mRNA vaccines received 90–179 days before illness onset compared to unvaccinated patients. CI = confidence interval, IQR = interquartile range. ^aSome estimates are imprecise, which might be due to a relatively small number of persons in each level of vaccination or case status. This imprecision indicates that the actual vaccine effectiveness could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution.

**FIGURE 2**
Absolute COVID‐19 vaccine effectiveness against COVID‐19‐associated severe in‐hospital outcomes among adults in the United States during September 8, 2022–August 31, 2023, including effectiveness of original monovalent vaccines only, mRNA bivalent vaccines received 7–89 days before illness onset, and mRNA bivalent vaccines received 90–179 days before illness onset compared to unvaccinated patients. CI = confidence interval, ICU = intensive care unit, IMV = invasive mechanical ventilation, IQR = interquartile range. ^aSome estimates are imprecise, which might be due to a relatively small number of persons in each level of vaccination or case status. This imprecision indicates that the actual VE could be substantially different from the point estimate shown, and estimates should therefore be interpreted with caution.

See this image and copyright information in PMC

References

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Effectiveness of Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Hospitalization and Severe In-Hospital Outcomes Among Adults in the United States, September 2022-August 2023

Affiliations

Effectiveness of Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Hospitalization and Severe In-Hospital Outcomes Among Adults in the United States, September 2022-August 2023

Authors

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Abstract

Conflict of interest statement

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