Article ; Online: Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.
2022 Volume 28, Issue 4, Page(s) 823–830
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) ...
| 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) log |
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| MeSH term(s) | 2019-nCoV Vaccine mRNA-1273 ; COVID-19/epidemiology ; COVID-19/prevention & control ; Humans ; SARS-CoV-2/genetics ; United States | ||||||||||
| Chemical Substances | 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) | ||||||||||
| Language | English | ||||||||||
| Publishing date | 2022-02-10 | ||||||||||
| Publishing country | United States | ||||||||||
| Document type | Clinical Trial, Phase III ; Journal Article | ||||||||||
| ZDB-ID | 1220066-9 | ||||||||||
| ISSN | 1546-170X ; 1078-8956 | ||||||||||
| ISSN (online) | 1546-170X | ||||||||||
| ISSN | 1078-8956 | ||||||||||
| DOI | 10.1038/s41591-022-01679-5 | ||||||||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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