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. 2022 Oct 21;71(42):1327-1334.
doi: 10.15585/mmwr.mm7142a3.

Effectiveness of Monovalent mRNA Vaccines Against COVID-19-Associated Hospitalization Among Immunocompetent Adults During BA.1/BA.2 and BA.4/BA.5 Predominant Periods of SARS-CoV-2 Omicron Variant in the United States - IVY Network, 18 States, December 26, 2021-August 31, 2022

Diya Surie, Levi Bonnell, Katherine Adams, Manjusha Gaglani, Adit A Ginde, David J Douin, H Keipp Talbot, Jonathan D Casey, Nicholas M Mohr, Anne Zepeski, Tresa McNeal, Shekhar Ghamande, Kevin W Gibbs, D Clark Files, David N Hager, Arber Shehu, Anne P Frosch, Heidi L Erickson, Michelle N Gong, Amira Mohamed, Nicholas J Johnson, Vasisht Srinivasan, Jay S Steingrub, Ithan D Peltan, Samuel M Brown, Emily T Martin, Akram Khan, William S Bender, Abhijit Duggal, Jennifer G Wilson, Nida Qadir, Steven Y Chang, Christopher Mallow, Carolina Rivas, Jennie H Kwon, Matthew C Exline, Adam S Lauring, Nathan I Shapiro, Natasha Halasa, James D Chappell, Carlos G Grijalva, Todd W Rice, William B Stubblefield, Adrienne Baughman, Kelsey N Womack, Kimberly W Hart, Sydney A Swan, Yuwei Zhu, Jennifer DeCuir, Mark W Tenforde, Manish M Patel, Meredith L McMorrow, Wesley H Self; IVY Network
Collaborators, Affiliations

Effectiveness of Monovalent mRNA Vaccines Against COVID-19-Associated Hospitalization Among Immunocompetent Adults During BA.1/BA.2 and BA.4/BA.5 Predominant Periods of SARS-CoV-2 Omicron Variant in the United States - IVY Network, 18 States, December 26, 2021-August 31, 2022

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

Abstract

The SARS-CoV-2 Omicron variant (B.1.1.529 or BA.1) became predominant in the United States by late December 2021 (1). BA.1 has since been replaced by emerging lineages BA.2 (including BA.2.12.1) in March 2022, followed by BA.4 and BA.5, which have accounted for a majority of SARS-CoV-2 infections since late June 2022 (1). Data on the effectiveness of monovalent mRNA COVID-19 vaccines against BA.4/BA.5-associated hospitalizations are limited, and their interpretation is complicated by waning of vaccine-induced immunity (2-5). Further, infections with earlier Omicron lineages, including BA.1 and BA.2, reduce vaccine effectiveness (VE) estimates because certain persons in the referent unvaccinated group have protection from infection-induced immunity. The IVY Network† assessed effectiveness of 2, 3, and 4 doses of monovalent mRNA vaccines compared with no vaccination against COVID-19-associated hospitalization among immunocompetent adults aged ≥18 years during December 26, 2021-August 31, 2022. During the BA.1/BA.2 period, VE 14-150 days after a second dose was 63% and decreased to 34% after 150 days. Similarly, VE 7-120 days after a third dose was 79% and decreased to 41% after 120 days. VE 7-120 days after a fourth dose was 61%. During the BA.4/BA.5 period, similar trends were observed, although CIs for VE estimates between categories of time since the last dose overlapped. VE 14-150 days and >150 days after a second dose was 83% and 37%, respectively. VE 7-120 days and >120 days after a third dose was 60%and 29%, respectively. VE 7-120 days after the fourth dose was 61%. Protection against COVID-19-associated hospitalization waned even after a third dose. The newly authorized bivalent COVID-19 vaccines include mRNA from the ancestral SARS-CoV-2 strain and from shared mRNA components between BA.4 and BA.5 lineages and are expected to be more immunogenic against BA.4/BA.5 than monovalent mRNA COVID-19 vaccines (6-8). All eligible adults aged ≥18 years§ should receive a booster dose, which currently consists of a bivalent mRNA vaccine, to maximize protection against BA.4/BA.5 and prevent COVID-19-associated hospitalization.

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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 personal fees from Hamilton Ventilators outside the submitted work. Jonathan D. Casey reports grants from the National Institutes of Health (NIH) and U.S. Department of Defense (DoD), outside the submitted work. Steven Y. Chang reports consulting for PureTech Health in 2020 and Kiniksa Pharmaceuticals and membership on the safety monitoring board (DSMB) for an investigator-initiated study at UCLA. James D. Chappell reports grants from NIH and DoD during the conduct of the study. David J. Douin reports grants received from NIH and National Institute of General Medical Sciences, outside the submitted work. Abhijit Duggal reports grants from NIH and participation on a steering committee for ALung technologies, outside the submitted work. Matthew C. Exline reports grants from the NIH and Regeneron, as well as support from Abbott Labs for sponsored talks, outside the submitted work. D. Clark Files reports personal consultant fees from Cytovale and membership on DSMB from Medpace, outside the submitted work. Anne P. Frosch reports grants from NIH, outside the submitted work. Manjusha Gaglani reports grants from Abt Associates, Westat, Janssen, and participation 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 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 NIH, speaking at medicine grand rounds at New York Medical College, travel support for the American Thoracic Society executive meeting, DSMB membership fees from Regeneron, and participation on the scientific advisory panel for Endpoint, outside the submitted work. Carlos G. Grijalva reports consultancy fees from Pfizer, Merck, and Sanofi-Pasteur; grants from Campbell Alliance/Syneos Health, NIH, the Food and Drug Administration, Agency for Healthcare Research and Quality, and Sanofi, outside the submitted work. David N. Hager grants from NIH, 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 the 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, outside the submitted work. Jennie H. Kwon reports grants from National Institute of Allergy and Infectious Diseases (NIAID), outside the submitted work. Adam S. Lauring reports personal fees from Sanofi and Roche and grants from NIAID, Burroughs Wellcome Fund, Flu Lab, outside the submitted work. Emily T. Martin reports grants from Merck, outside the submitted work. Tresa McNeal reports participation 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 Abbvie Inc, and 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 grants from NIH, and 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.

Figures

FIGURE
FIGURE
Numbers of COVID-19 cases and SARS-CoV-2 whole genome–sequenced lineages,, among immunocompetent adults hospitalized with COVID-19 — IVY Network, 21 hospitals in 18 U.S. states, December 26, 2021–August 24, 2022 * N = 4,543. † Number of SARS-CoV-2 whole genome–sequenced lineages: BA.1 = 349; BA.2 = 568; BA.4 = 91; and BA.5 = 376. § Upper respiratory specimens collected from COVID-19 patients for detection of SARS-CoV-2 by reverse transcription–polymerase chain reaction (RT-PCR) were eligible for whole genome sequencing. During the early BA.1 period (December 26, 2021–January 14, 2022), all specimens testing positive for SARS-CoV-2 by RT-PCR were submitted for whole genome sequencing; from January 15, 2022 onward, only specimens testing positive for SARS-CoV-2 by RT-PCR with a cycle threshold <32 for at least one of two nucleocapsid gene targets tested underwent whole genome sequencing. SARS-CoV-2 lineages were assigned by using PANGO on genomes with >80% coverage. BA.1, BA.2, BA.4, and BA.5 lineages. Among specimens from 568 patients who received test results indicating BA.2 lineage, 343 (60%) indicated BA.2.12.1 lineage. ** Barnes-Jewish Hospital (St. Louis, Missouri), Baylor Scott & White Health (Temple, Texas), Baystate Medical Center (Springfield, Massachusetts), Beth Israel Deaconess Medical Center (Boston, Massachusetts), Cleveland Clinic (Cleveland, Ohio), Emory University Medical Center (Atlanta, Georgia), Hennepin County Medical Center (Minneapolis, Minnesota), Intermountain Medical Center (Murray, Utah), Johns Hopkins Hospital (Baltimore, Maryland), Montefiore Medical Center (New York, New York), Oregon Health & Science University Hospital (Portland, Oregon), Ronald Reagan UCLA Medical Center (Los Angeles, California), Stanford University Medical Center (Stanford, California), The Ohio State University Wexner Medical Center (Columbus, Ohio), UCHealth University of Colorado Hospital (Aurora, Colorado), University of Iowa Hospitals (Iowa City, Iowa), University of Miami Medical Center (Miami, Florida), University of Michigan Hospital (Ann Arbor, Michigan), University of Washington Medical Center (Seattle, Washington), Vanderbilt University Medical Center (Nashville, Tennessee), Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina). †† Sequencing results complete through August 24, 2022. Low numbers of COVID-19 cases and SARS-CoV-2 whole genome–sequenced lineages in late January reflect an administrative pause in IVY Network enrollment during January 25–31, 2022.
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