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[Preprint]. 2024 Jun 5:2024.06.04.24308470.
doi: 10.1101/2024.06.04.24308470.

Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccination Against SARS-CoV-2 Omicron XBB and BA.2.86/JN.1 Lineage Hospitalization and a Comparison of Clinical Severity - IVY Network, 26 Hospitals, October 18, 2023-March 9, 2024

Kevin C Ma  1 , Diya Surie  1 , Adam S Lauring  2 , Emily T Martin  2 , Aleda M Leis  2 , Leigh Papalambros  2 , Manjusha Gaglani  3   4 , Christie Columbus  3 , Robert L Gottlieb  3 , Shekhar Ghamande  4 , Ithan D Peltan  5 , Samuel M Brown  5 , Adit A Ginde  6 , Nicholas M Mohr  7 , Kevin W Gibbs  8 , David N Hager  9 , Safa Saeed  9 , Matthew E Prekker  10 , Michelle Ng Gong  11 , Amira Mohamed  11 , Nicholas J Johnson  12 , Vasisht Srinivasan  12 , Jay S Steingrub  13 , Akram Khan  14 , Catherine L Hough  14 , Abhijit Duggal  15 , Jennifer G Wilson  16 , Nida Qadir  17 , Steven Y Chang  17 , Christopher Mallow  18 , Jennie H Kwon  19 , Bijal Parikh  19 , Matthew C Exline  20 , Ivana A Vaughn  21 , Mayur Ramesh  21 , Basmah Safdar  22 , Jarrod Mosier  23 , Estelle S Harris  24 , Nathan I Shapiro  25 , Jamie Felzer  26 , Yuwei Zhu  27 , Carlos G Grijalva  27 , Natasha Halasa  27 , James D Chappell  27 , Kelsey N Womack  27 , Jillian P Rhoads  27 , Adrienne Baughman  27 , Sydney A Swan  27 , Cassandra A Johnson  27 , Todd W Rice  27 , Jonathan D Casey  27 , Paul W Blair  27 , Jin H Han  27 , Sascha Ellington  1 , Nathaniel M Lewis  1 , Natalie Thornburg  1 , Clinton R Paden  1 , Lydia J Atherton  1 , Wesley H Self  27 , Fatimah S Dawood  1 , Jennifer DeCuir  1
Affiliations

Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccination Against SARS-CoV-2 Omicron XBB and BA.2.86/JN.1 Lineage Hospitalization and a Comparison of Clinical Severity - IVY Network, 26 Hospitals, October 18, 2023-March 9, 2024

Kevin C Ma et al. medRxiv. .

Update in

Abstract

Background: Assessing COVID-19 vaccine effectiveness (VE) and severity of SARS-CoV-2 variants can inform public health risk assessments and decisions about vaccine composition. BA.2.86 and its descendants, including JN.1 (referred to collectively as "JN lineages"), emerged in late 2023 and exhibited substantial genomic divergence from co-circulating XBB lineages.

Methods: We analyzed patients hospitalized with COVID-19-like illness at 26 hospitals in 20 U.S. states admitted October 18, 2023-March 9, 2024. Using a test-negative, case-control design, we estimated the effectiveness of an updated 2023-2024 (Monovalent XBB.1.5) COVID-19 vaccine dose against sequence-confirmed XBB and JN lineage hospitalization using logistic regression. Odds of severe outcomes, including intensive care unit (ICU) admission and invasive mechanical ventilation (IMV) or death, were compared for JN versus XBB lineage hospitalizations using logistic regression.

Results: 585 case-patients with XBB lineages, 397 case-patients with JN lineages, and 4,580 control-patients were included. VE in the first 7-89 days after receipt of an updated dose was 54.2% (95% CI = 36.1%-67.1%) against XBB lineage hospitalization and 32.7% (95% CI = 1.9%-53.8%) against JN lineage hospitalization. Odds of ICU admission (adjusted odds ratio [aOR] 0.80; 95% CI = 0.46-1.38) and IMV or death (aOR 0.69; 95% CI = 0.34-1.40) were not significantly different among JN compared to XBB lineage hospitalizations.

Conclusions: Updated 2023-2024 COVID-19 vaccination provided protection against both XBB and JN lineage hospitalization, but protection against the latter may be attenuated by immune escape. Clinical severity of JN lineage hospitalizations was not higher relative to XBB lineage hospitalizations.

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Conflict of interest statement

Potential conflicts of interest. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. James D. Chappell. MD, PhD reports grant support by Merck, outside the submitted work. Manjusha Gaglani, MBBS reports grants from CDC, CDC-Abt and CDC-Westat sponsored studies, serving as the Emeritus Chair of TPS IDI Committee (Co-Chair from Sept 2016 - August 2022) and ex TPS Texas RSV Taskforce Chair (May 2021- August 2022), outside the submitted work. Robert L Gottlieb, MD, PhD reports grants or contracts to his institution from AstraZeneca, Eli Lilly, Gilead, Johnson & Johnson, Pfizer, Regeneron, and Roivant Sciences (Kinevant Sciences), participation on advisory boards and/or consulting fees from AbbVie, AstraZeneca, Eli Lilly, Gilead Sciences, GSK Pharmaceuticals, and Roche, payment or honoraria for lectures/speaker from Gilead Sciences, and Pfizer (the latter unrelated to infectious diseases), travel support from Gilead Sciences, de minimis investment in AbCellera, and a gift-in-kind to his institution from Gilead Sciences to facilitate an unrelated academic-sponsored clinical trial (NCT03383419), outside the submitted work. Carlos G. Grijalva, MD MPH reports research support from CDC, NIH, AHRQ, Syneos Health and FDA, and has served in a Scientific Advisory Board for Merck, outside the submitted work. Natasha Halasa reports current funding from Merck and served on an advisory board for CSL-Seqirus, outside the submitted work. Adam S. Lauring, MD, PhD reports funding from NIAID, CDC, MDHHS, Burroughs Wellcome Fund, and consulting fees from Roche, outside the submitted work. Ithan D. Peltan reports funding from the National Institute of General Medical Studies (R35GM151147), grants from NIH and Janssen Pharmaceuticals, and funding to his institution from Regeneron and Bluejay Diagnostics, outside the submitted work. Mayur Ramesh MD reports participating as an unbranded speaker for AstraZeneca, and serving on an advisory board for Pfizer and Moderna, outside the submitted work. Ivana A. Vaughn reports grant funding from CDC via University of Michigan for US Flu VE Network, as well as eMaxHealth, outside the submitted work. Michelle Ng Gong reports funding from NIH and serving on a scientific advisory panel for Regeneron, Radiometer, Novartis, Philips Healthcare, and serving on the DSMB for clinical trials for NIH and nutrition, outside the submitted work. Catherine L. Hough, MD MSc reports funding from NIH, outside the submitted work. No other potential conflicts of interest were disclosed.

Figures

Figure 1.
Figure 1.. Number of COVID-19 case-patients by hospital admission week and SARS-CoV-2 lineage — IVY Network, 26 Hospitals, October 18, 2023–March 9, 2024.
Identification of a SARS-CoV-2 lineage was determined by viral whole-genome sequencing. For analytic purposes, SARS-CoV-2 lineage categories “BA.2.86 or BA.2.86.1,” “JN.1 or descendants,” and “Other JN lineages” were grouped and collectively referred to as “JN lineages.” * Dates are for the end of the admission week.
Figure 2.
Figure 2.. Effectiveness of updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination against COVID-19–associated hospitalization from XBB and JN lineage infection — IVY Network, 26 Hospitals, October 18, 2023–March 9, 2024.
Vaccine effectiveness was calculated as (1 – adjusted odds ratio) × 100% with odds ratios calculated using multivariable logistic regression adjusting for age, sex, race/ethnicity, HHS region, admission date in biweekly intervals, and Charlson comorbidity index. a Based on timing of recommendations to receive updated 2023–2024 COVID-19 vaccines and JN lineage emergence, limited numbers of individuals with XBB infection were 90–179 days from their updated dose, precluding estimation of VE within this stratum. b Some 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. Abbreviations: IQR = interquartile range; CI = confidence interval; HHS = U.S. Department of Health and Human Services
Figure 3.
Figure 3.. Adjusted odds ratios of severe in-hospital outcomes among adults hospitalized with COVID-19 (JN versus XBB lineage hospitalization) — IVY Network, 26 Hospitals, October 18, 2023–March 9, 2024.
Multivariable logistic regression was used to estimate the odds of each outcome among patients with JN versus XBB lineage infection adjusting for age, sex, race/ethnicity, HHS region, admission date in biweekly intervals, Charlson comorbidity index, and COVID-19 vaccination status. a Supplemental oxygen therapy was defined as supplemental oxygen at any flow rate and by any device for those not on chronic oxygen therapy, or with escalation of oxygen therapy for patients receiving chronic oxygen therapy. b Advanced respiratory support was defined as new receipt of high-flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation. Abbreviations: CI = confidence interval; ICU = intensive care unit; IMV = invasive mechanical ventilation
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