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Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years - IVY Network, 18 States, September 8-November 30, 2022

Diya Surie et al. MMWR Morb Mortal Wkly Rep. .

Abstract

Monovalent COVID-19 mRNA vaccines, designed against the ancestral strain of SARS-CoV-2, successfully reduced COVID-19-related morbidity and mortality in the United States and globally (1,2). However, vaccine effectiveness (VE) against COVID-19-associated hospitalization has declined over time, likely related to a combination of factors, including waning immunity and, with the emergence of the Omicron variant and its sublineages, immune evasion (3). To address these factors, on September 1, 2022, the Advisory Committee on Immunization Practices recommended a bivalent COVID-19 mRNA booster (bivalent booster) dose, developed against the spike protein from ancestral SARS-CoV-2 and Omicron BA.4/BA.5 sublineages, for persons who had completed at least a primary COVID-19 vaccination series (with or without monovalent booster doses) ≥2 months earlier (4). Data on the effectiveness of a bivalent booster dose against COVID-19 hospitalization in the United States are lacking, including among older adults, who are at highest risk for severe COVID-19-associated illness. During September 8-November 30, 2022, the Investigating Respiratory Viruses in the Acutely Ill (IVY) Network§ assessed effectiveness of a bivalent booster dose received after ≥2 doses of monovalent mRNA vaccine against COVID-19-associated hospitalization among immunocompetent adults aged ≥65 years. When compared with unvaccinated persons, VE of a bivalent booster dose received ≥7 days before illness onset (median = 29 days) against COVID-19-associated hospitalization was 84%. Compared with persons who received ≥2 monovalent-only mRNA vaccine doses, relative VE of a bivalent booster dose was 73%. These early findings show that a bivalent booster dose provided strong protection against COVID-19-associated hospitalization in older adults and additional protection among persons with previous monovalent-only mRNA vaccination. All eligible persons, especially adults aged ≥65 years, should receive a bivalent booster dose to maximize protection against COVID-19 hospitalization this winter season. Additional strategies to prevent respiratory illness, such as masking in indoor public spaces, should also be considered, especially in areas where COVID-19 community levels are high (4,5).

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Conflict of interest statement

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Samuel M. Brown reports serving as the data and safety monitoring board (DSMB) chair for Hamilton Ventilators outside the submitted work. Jonathan D. Casey reports grants from the National Institutes of Health (NIH) and Department of Defense (DoD), outside the submitted work. Steven Y. Chang consulted for PureTech Health in 2020 and Kiniksa Pharmaceuticals and is a DSMB member for an investigator-initiated study at UCLA. James D. Chappell reports grants from NIH and DoD during the conduct of the study. Cristie Columbus reports support from Baylor University Medical Center for meeting attendance, an advisory role to the Dallas County Public Health Committee, and other interests as the Chief of the Division of Infectious Diseases at Baylor University Medical Center and the Medical Director for Infection Prevention and Control/Healthcare epidemiology, outside the submitted work. David J. Douin reports grants received from NIH and the National Institute of General Medical Sciences, outside the submitted work. Abhijit Duggal reports grants from NIH and the National Heart, Lung, and Blood Institute (NHLBI), and participation on a Steering Committee for ALung technologies, outside the submitted work. Matthew C. Exline reports grants from NIH and Regeneron, as well as support from Abbott Labs and Medical Legal Expert Witness for sponsored talks, outside the submitted work. D. Clark Files reports personal consultant fees from Global Blood Therapeutics and is a DSMB member from Medpace, outside the submitted work. Manjusha Gaglani reports grants from CDC-Abt Associates, CDC-Westat, and Janssen, and participates as co-chair on the Infection Diseases and Immunizations Committee for the Texas Pediatric Society, outside the submitted work. Kevin W. Gibbs reports grants from NIH and DoD, and DoD funds for the Military Health System Research Symposium travel in 2022, outside the submitted work. Adit A. Ginde reports grants from NIH, DoD, AbbVie, and Faron Pharmaceuticals, outside the submitted work. Michelle N. Gong reports grants from NHLBI and the Agency for Healthcare Research and Quality (AHRQ), speaking at medicine grand rounds at New York Medical College, travel support for the American Thoracic Society (ATS) executive meeting and serving as ATS Chair Critical Care Assembly, DSMB membership fees from Regeneron, and participating on the scientific advisory panel for Endpoint, outside the submitted work. Carlos G. Grijalva reports consultancy fees from Merck; grants from Campbell Alliance/Syneos Health, NIH, the Food and Drug Administration, and AHRQ outside the submitted work. David N. Hager reports grants from NHLBI outside the submitted work. Natasha Halasa reports grants and nonfinancial support from Sanofi, and grants from Quidel outside the submitted work. Nicholas J. Johnson reports grants from NIH, DoD, University of Washington, and Medic One Foundation, outside the submitted work. Akram Khan reports grants from United Therapeutics, Johnson & Johnson, Ely Lilly, 4D Medical, Dompe Pharmaceuticals and GlaxoSmithKline, and serves on the Guidelines committee for Chest, outside the submitted work. Jennie H. Kwon reports grants from NIH outside the submitted work. Adam S. Lauring reports personal fees from Sanofi and Roche and grants from the National Institute for Allergy and Infectious Diseases, Burroughs Wellcome Fund, Flu Lab, outside the submitted work. Emily T. Martin reports grants from Merck, Flu Lab, and NIH, outside the submitted work. Tresa McNeal reports grants from participating as a webinar invited panelist and a Practice Management Committee member for Society of Hospital Medicine, outside the submitted work. Ithan D. Peltan reports grants from NIH, Janssen Pharmaceuticals, and institutional support from Asahi Kasei Pharma and Regeneron, outside the submitted work. Todd W. Rice reports grants from NIH and DoD, personal fees from Cumberland Pharmaceuticals, Inc., Cytovale, Inc., and Sanofi, Inc., outside the submitted work. William B. Stubblefield reports grants from NIH outside the submitted work. Jennifer G. Wilson reports personal funds from the American College of Emergency Physicians and American Board of Internal Medicine outside the submitted work. No other potential conflicts of interest were disclosed.

References

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Supplementary concepts