https://orcid.org/0000-0002-0816-7345
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ABSTRACT
Emerging SARS-CoV-2 sublineages continue to cause serious COVID-19 disease, but most individuals have not received any COVID-19 vaccine for >1 year. Assessment of long-term effectiveness of bivalent COVID-19 vaccines against circulating sublineages is important to inform the potential need for vaccination with updated vaccines. In this test-negative study at Kaiser Permanente Southern California, sequencing-confirmed BA.4/BA.5- or XBB-related SARS-CoV-2-positive cases (September 1, 2022 to June 30, 2023), were matched 1:3 to SARS-CoV-2-negative controls. We assessed mRNA-1273 bivalent relative (rVE) and absolute vaccine effectiveness (VE) compared to ≥2 or 0 doses of original monovalent vaccine, respectively. The rVE analysis included 20,966 cases and 62,898 controls. rVE (95%CI) against BA.4/BA.5 at 14–60 days and 121–180 days was 52.7% (46.9–57.8%) and 35.5% (−2.8–59.5%) for infection, and 59.3% (49.7–67.0%) and 33.2% (−28.2–68.0%) for Emergency Department/Urgent Care (ED/UC) encounters. For BA.4/BA.5-related hospitalizations, rVE was 71.3% (44.9–85.1%) and 52.0% (−1.2–77.3%) at 14–60 days and 61–120 days, respectively. rVE against XBB at 14–60 days and 121–180 days was 48.8% (33.4–60.7%) and −3.9% (−18.1–11.3%) for infection, 70.7% (52.4–82.0%) and 15.7% (−6.0–33.2%) for ED/UC encounters, and 87.9% (43.8–97.4%) and 57.1% (17.0–77.8%) for hospitalization. VE and subgroup analyses (age, immunocompromised status, previous SARS-CoV-2 infection) results were similar to rVE analyses. rVE of mRNA-1273 bivalent vaccine against BA.4/BA.5 and XBB infections, ED/UC encounters, and hospitalizations waned over time. Periodic revaccination with vaccines targeting emerging variants may be important in reducing COVID-19 morbidity and mortality.
Acknowledgments
The authors would like to acknowledge the following Kaiser Permanente Southern California staff: Maria Navarro, Elsa Olvera, Joy Gelfond, Jonathan Arguello, Diana Romero, Joanna Truong, Samuel Payan, Sierra Lewis, Brittany Brown, and Hiba Atif for their contributions in manual chart reviews of the electronic health records; and Elmer Ayala, Samantha Bayulot, Candice Beissel, Jared Davis, Sarbjit Kaur-Chand, Kourtney Kottmann, Samantha Quinones, Jose Rodriguez, Charanjot (Joe) Singh, Katy Taylor, Joanna Truong, and Vanessa Pan for technical and laboratory support in processing SARS-CoV-2 specimens. The authors would like to acknowledge HelixOpCo, LLC, for their WGS of SARS-CoV-2 specimens. The authors would also like to acknowledge the contributions by Moderna, Inc. staff: Christine Yu and Yamuna Paila. Editorial assistance was provided by Rachel Schultz, MA, ELS, of MEDiSTRAVA in accordance with Good Publication Practice (GPP3) guidelines, funded by Moderna, Inc., and under the direction of the authors. The authors thank the patients of Kaiser Permanente for their partnership with us to improve their health. Their information, collected through our electronic health record systems, leads to findings that help us improve care for our members and can be shared with the larger community.
Disclosure statement
BKA, LQ, LSS, SQ, JET, GSL, JHK, YL, RB, JS, SKC, HST, MA, and HFT are employees of Kaiser Permanente Southern California (KPSC), contracted by Moderna, Inc. to conduct this study. KJB is an adjunct investigator at (KPSC). AF was an employee of (KPSC); currently an employee of SimulStat. MAM, EJA, CKZ, and TS are employees of and shareholders in Moderna, Inc. CAT was an employee of and a shareholder in Moderna Inc at the time of protocol development; currently an employee of AstraZeneca. BKA received funding from GlaxoSmithKline, Dynavax, Genentech, and Moderna unrelated to this manuscript. LQ received funding from GlaxoSmithKline, Dynavax, and Moderna unrelated to this manuscript. LSS received funding from GlaxoSmithKline, Dynavax, and Moderna unrelated to this manuscript. KJB received funding from GlaxoSmithKline, Dynavax, and Pfizer unrelated to this manuscript. SQ received funding from Dynavax unrelated to this manuscript. JET received funding from Pfizer and Moderna unrelated to this manuscript. GSL, JHK, and HFT received funding from GlaxoSmithKline and Moderna unrelated to this manuscript. HFT served on advisory boards for Janssen and Pfizer. AF received funding from Pfizer, GlaxoSmithKline, Gilead, and Moderna unrelated to this manuscript. YL received funding from GlaxoSmithKline, Pfizer, and Moderna unrelated to this manuscript. RB received funding from GlaxoSmithKline unrelated to this manuscript. JS received funding from Pfizer, Sanofi, and Intercept unrelated to this manuscript. SKC received funding from Pfizer, Bayer AG, and Pancreatic Cancer Action Network unrelated to this manuscript. HST received funding from GlaxoSmithKline, Pfizer, ALK, and Wellcome unrelated to this manuscript. MA received funding from Pfizer unrelated to this manuscript.
Author contributions
BKA, KJB, LQ, LSS, JHK, AF, MAM, CAT, and HFT conceived and designed the study. BKA, KJB, LQ, LSS, SQ, JET, GSL, JHK, AF, YL, RB, JS, SKC, HST, MA, MAM, EJA, CKZ, TS, CAT, and HFT were involved in acquisition, analysis, or interpretation of data. BKA and KJB developed the first draft of the manuscript. LQ, LSS, SQ, JET, GSL, JHK, AF, YL, RB, JS, SKC, HST, MA, MAM, EJA, CKZ, TS, CAT, and HFT were involved in the critical revision of the manuscript for important intellectual content. LQ, YL, JET, and SQ performed statistical analysis. CAT and HFT obtained funding for the study. GSL, LSS, and MAM provided administrative, technical, or material support. MAM, CAT, and HFT provided project supervision. All authors contributed to the writing of the manuscript and approved the final version for publication.
Data sharing statement
Individual-level data reported in this study involving human research participants are not publicly shared due to potentially identifying or sensitive patient information. Upon request to corresponding author [BKA], and subject to review and approval of an analysis proposal, KPSC may provide the deidentified aggregate-level data that support the findings of this study within 6 months. Anonymized data (deidentified data including participant data as applicable) that support the findings of this study may be made available from the investigative team in the following conditions: (1) agreement to collaborate with the study team on all publications, (2) provision of external funding for administrative and investigator time necessary for this collaboration, (3) demonstration that the external investigative team is qualified and has documented evidence of training for human subjects protections, and (4) agreement to abide by the terms outlined in data use agreements between institutions.
Supplementary material
Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2024.2335052
Correction Statement
This article has been corrected with minor changes. These changes do not impact the academic content of the article.