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

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.

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Publication Details

Journal
Nature Communications
Published
2024-08-29
DOI
https://doi.org/10.1038/s41467-024-50376-z
Citations
34
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
13.23

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article

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

Weiping Deng, Bethany Girard, Haiyu Zhou, Susanne Doblecki‐Lewis et al.
34 citations
Nature Communications
SARS-CoV-2 and COVID-19 Research
13.23
article

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

Weiping Deng, Bethany Girard, Haiyu Zhou, Susanne Doblecki‐Lewis, Avika Dixit, Hana M. El Sahly, Cynthia Strout, Verónica Urdaneta, Joanne E. Tomassini, Frances Priddy, Kathleen M. Neuzil, Dean A. Follmann, Jacqueline M. Miller, Lawrence Corey, Evan J. Anderson, Lindsey Robert Baden, Dina Stolman, Gregory Hachigian, Xiaowei Wang, Rituparna Das, Jennifer A. Whitaker, Mollie Brown, J. Scott Overcash, Brandon Essink
article en
34 citations

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.

Nature CommunicationsVol. 15(1)
University of Maryland, Baltimore (US), Brigham and Women's Hospital (US), University of Miami (US), Emory University (US), Baylor College of Medicine (US), Fred Hutch Cancer Center (US), Benchmark Research (United States) (US), Moderna Therapeutics (United States) (US), National Institute of Allergy and Infectious Diseases (US), Velocity Clinical Research (United States) (US), Meridian Clinical Research (US)
U.S. Department of Health and Human Services, Massachusetts General Hospital, Vanderbilt University, University of Pennsylvania, Emory University, Tufts Medical Center, North Carolina State University, Johns Hopkins University, Vanderbilt University Medical Center, Moderna, Inyuvesi Yakwazulu-Natali, Universidade de São Paulo, Faculdade de Medicina da Universidade de São Paulo, Perelman School of Medicine, University of Pennsylvania, Johns Hopkins Bloomberg School of Public Health, Biomedical Advanced Research and Development Authority, Medical Research Council, National Institute of Allergy and Infectious Diseases
Good health and well-being
Openalex Percentile: Top 1%
SARS-CoV-2 and COVID-19 Research
13.23
DOIOpen Access PDFOpenAlex
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