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Initial Analysis of Viral Dynamics and Circulating Viral Variants During the mRNA-1273 Phase 3 COVE Trial
Rolando Pajon; Yamuna Paila; Bethany Girard; Groves Dixon; Katherine Kacena; Lindsey R Baden; Hana M El Sahly; Brandon Essink; Kathleen M Mullane; Ian Frank; Douglas Denham; Edward Kerwin; Xiaoping Zhao; Baoyu Ding; Weiping Deng; Joanne Tomassini; Honghong Zhou; Brett Leav; Florian Schodel.
Affiliation
  • Rolando Pajon; Moderna, Inc.
  • Yamuna Paila; Moderna, Inc.
  • Bethany Girard; Moderna, Inc.
  • Groves Dixon; Moderna, Inc.
  • Katherine Kacena; Moderna, Inc.
  • Lindsey R Baden; Brigham and Womens Hospital
  • Hana M El Sahly; Baylor College of Medicine
  • Brandon Essink; Meridian Clinical Research
  • Kathleen M Mullane; University of Chicago
  • Ian Frank; University of Pennsylvania
  • Douglas Denham; Clinical Trials of Texas
  • Edward Kerwin; Criscor Clinical Research Institute
  • Xiaoping Zhao; Moderna, Inc.
  • Baoyu Ding; Moderna, Inc.
  • Weiping Deng; Moderna, Inc.
  • Joanne Tomassini; Moderna, Inc.
  • Honghong Zhou; Moderna, Inc.
  • Brett Leav; Moderna, Inc.
  • Florian Schodel; Moderna, Inc.
Preprint in English | medRxiv | ID: ppmedrxiv-21264252
ABSTRACT
This analysis assessed the impact of mRNA-1273 vaccination on the viral dynamics of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the ongoing Coronavirus Efficacy (COVE) trial. mRNA-1273 vaccination significantly reduced SARS-CoV-2 viral copy number (95% confidence interval [CI]) by 100-fold on the day of diagnosis (4.1 [3.4-4.8] versus placebo (6.2 [6.0-6.4] log10 copies/ml). Median times to undetectable viral copies were 4 days for mRNA-1273 and 7 for placebo. Vaccination also reduced the burden of disease and infection scores. Vaccine efficacies (95% CI) during the trial against SARS-CoV-2 variants circulating in the US were 82.4% (40.4%-94.8%) for Epsilon and Gamma, and 81.2% (36.1%-94.5%) for the Epsilon variants. The detection of other respiratory viruses during the trial was similar between groups. In those who became SARS-CoV-2 infected, the reduction of viral load after mRNA-1273 vaccination is potentially correlated to the risk of transmission, which has not been assessed in this study.
License
cc_by_nc_nd
Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental_studies / Prognostic study / Rct Language: English Year: 2021 Document type: Preprint
Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental_studies / Prognostic study / Rct Language: English Year: 2021 Document type: Preprint
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