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Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases

Author

Listed:
  • Lindsey R. Baden

    (Brigham and Women’s Hospital)

  • Hana M. El Sahly

    (Baylor College of Medicine)

  • Brandon Essink

    (Meridian Clinical Research Omaha)

  • Dean Follmann

    (National Institute of Allergy and Infectious Disease)

  • Gregory Hachigian

    (Benchmark Research)

  • Cynthia Strout

    (Coastal Carolina Research Center)

  • J. Scott Overcash

    (Velocity Clinical Research)

  • Susanne Doblecki-Lewis

    (University of Miami)

  • Jennifer A. Whitaker

    (Baylor College of Medicine)

  • Evan J. Anderson

    (Emory University School of Medicine)

  • Kathleen Neuzil

    (University of Maryland)

  • Lawrence Corey

    (Fred Hutchinson Cancer Research Center)

  • Frances Priddy

    (Inc.)

  • Joanne E. Tomassini

    (Inc.)

  • Mollie Brown

    (Inc.)

  • Bethany Girard

    (Inc.)

  • Dina Stolman

    (Inc.)

  • Veronica Urdaneta

    (Inc.)

  • Xiaowei Wang

    (Inc.)

  • Weiping Deng

    (Inc.)

  • Honghong Zhou

    (Inc.)

  • Avika Dixit

    (Inc.)

  • Rituparna Das

    (Inc.)

  • Jacqueline M. Miller

    (Inc.)

Abstract

Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 − 25.8] vs 46.4 [40.6 − 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% − 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

Suggested Citation

  • Lindsey R. Baden & Hana M. El Sahly & Brandon Essink & Dean Follmann & Gregory Hachigian & Cynthia Strout & J. Scott Overcash & Susanne Doblecki-Lewis & Jennifer A. Whitaker & Evan J. Anderson & Kathl, 2024. "Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases," Nature Communications, Nature, vol. 15(1), pages 1-13, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-50376-z
    DOI: 10.1038/s41467-024-50376-z
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    References listed on IDEAS

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    1. Spyros Chalkias & Charles Harper & Keith Vrbicky & Stephen R. Walsh & Brandon Essink & Adam Brosz & Nichole McGhee & Joanne E. Tomassini & Xing Chen & Ying Chang & Andrea Sutherland & David C. Montefi, 2023. "Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19," Nature Communications, Nature, vol. 14(1), pages 1-7, December.
    2. Julia Stowe & Nick Andrews & Freja Kirsebom & Mary Ramsay & Jamie Lopez Bernal, 2022. "Effectiveness of COVID-19 vaccines against Omicron and Delta hospitalisation, a test negative case-control study," Nature Communications, Nature, vol. 13(1), pages 1-8, December.
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