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

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, Kathleen Neuzil, Lawrence Corey, Frances Priddy, Joanne E. Tomassini, Mollie Brown, Bethany Girard, Dina Stolman, Veronica Urdaneta, Xiaowei Wang, Weiping Deng, Honghong Zhou, Avika Dixit, Rituparna Das and Jacqueline M. Miller
Additional contact information
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.

Nature Communications, 2024, vol. 15, issue 1, 1-13

Abstract: 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.

Date: 2024
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DOI: 10.1038/s41467-024-50376-z

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