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 10 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.
【초록키워드】 COVID-19, coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, Efficacy, coronavirus, vaccination, Trial, Open-label, mRNA-1273, SARS-COV-2 infection, variant, SARS-CoV-2 variant, vaccine efficacy, Infection, Diagnosis, risk, virus transmission, drug, Emergency use authorization, variants, respiratory viruses, SARS-CoV-2 variants, mRNA, symptomatic, Epsilon, Gamma, Viral variants, shedding, viral dynamics, Placebo, Viral RNA, United States, disease, SARS-CoV-2 infections, marker, food, Analysis, severe disease, phase, copy number, reduction, mRNA-1273 vaccine, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, 95% confidence interval, These data, COVID-19 case, infected individuals, participant, Exploratory analyses, circulating, SARS-CoV-2-infected individuals, while, prevention of COVID-19, SARS-CoV-2 viral, log, sequenced, blinded, significantly, respiratory virus, the United State, detectable, reduced, demonstrated, groups, receive, Coronavirus Efficacy, COVE trial, undetectable, 【제목키워드】 Analysis, phase, circulating viral variant, COVE trial,