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Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.
Pajon, Rolando; Paila, Yamuna D; Girard, Bethany; Dixon, Groves; Kacena, Katherine; Baden, Lindsey R; El Sahly, Hana M; Essink, Brandon; Mullane, Kathleen M; Frank, Ian; Denhan, Douglas; Kerwin, Edward; Zhao, Xiaoping; Ding, Baoyu; Deng, Weiping; Tomassini, Joanne E; Zhou, Honghong; Leav, Brett; Schödel, Florian.
  • Pajon R; Moderna, Inc., Cambridge, MA, USA. rolando.pajon@modernatx.com.
  • Paila YD; Moderna, Inc., Cambridge, MA, USA.
  • Girard B; Moderna, Inc., Cambridge, MA, USA.
  • Dixon G; Moderna, Inc., Cambridge, MA, USA.
  • Kacena K; Moderna, Inc., Cambridge, MA, USA.
  • Baden LR; Brigham and Women's Hospital, Boston, MA, USA.
  • El Sahly HM; Baylor College of Medicine, Houston, TX, USA.
  • Essink B; Meridian Clinical Research, Omaha, NE, USA.
  • Mullane KM; University of Chicago, Chicago, IL, USA.
  • Frank I; University of Pennsylvania, Philadelphia, PA, USA.
  • Denhan D; Clinical Trials of Texas, San Antonio, TX, USA.
  • Kerwin E; Criscor Clinical Research Institute, Medford, OR, USA.
  • Zhao X; Moderna, Inc., Cambridge, MA, USA.
  • Ding B; Moderna, Inc., Cambridge, MA, USA.
  • Deng W; Moderna, Inc., Cambridge, MA, USA.
  • Tomassini JE; Moderna, Inc., Cambridge, MA, USA.
  • Zhou H; Moderna, Inc., Cambridge, MA, USA.
  • Leav B; Moderna, Inc., Cambridge, MA, USA.
  • Schödel F; Moderna, Inc., Cambridge, MA, USA.
Nat Med ; 28(4): 823-830, 2022 04.
Article in English | MEDLINE | ID: covidwho-1684093
ABSTRACT
The mRNA-1273 vaccine for coronavirus disease 2019 (COVID-19) demonstrated 93.2% efficacy in reduction of symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in the blinded portion of the Phase 3 Coronavirus Efficacy (COVE) trial. While mRNA-1273 demonstrated high efficacy in prevention of COVID-19, including severe disease, its effect on the viral dynamics of SARS-CoV-2 infections is not understood. Here, in exploratory analyses, we assessed the impact of mRNA-1273 vaccination in the ongoing COVE trial (number NCT04470427) on SARS-CoV-2 copy number and shedding, burden of disease and infection, and viral variants. Viral variants were sequenced in all COVID-19 and adjudicated COVID-19 cases (n = 832), from July 2020 in the blinded part A of the study to May 2021 of the open-label part B of the study, in which participants in the placebo arm started to receive the mRNA-1273 vaccine after US Food and Drug Administration emergency use authorization of mRNA-1273 in December 2020. mRNA-1273 vaccination significantly reduced SARS-CoV-2 viral copy number (95% confidence interval) by 100-fold on the day of diagnosis compared with placebo (4.1 (3.4-4.8) versus 6.2 (6.0-6.4) log10 copies per ml). Median times to undetectable viral copies were 4 days for mRNA-1273 and 7 days for placebo. Vaccination also substantially reduced the burden of disease and infection scores. Vaccine efficacies (95% confidence interval) against SARS-CoV-2 variants circulating in the United States during the trial assessed in this post hoc analysis were 82.4% (40.4-94.8%) for variants Epsilon and Gamma and 81.2% (36.1-94.5%) for Epsilon. The detection of other, non-SARS-CoV-2, respiratory viruses during the trial was similar between groups. While additional study is needed, these data show that in SARS-CoV-2-infected individuals, vaccination reduced both the viral copy number and duration of detectable viral RNA, which may be markers for the risk of virus transmission.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans Country/Region as subject: North America Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2022 Document Type: Article Affiliation country: S41591-022-01679-5

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans Country/Region as subject: North America Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2022 Document Type: Article Affiliation country: S41591-022-01679-5