nference, Cambridge, MA 02142, USA.
Mayo Clinic, Rochester, MN 55902, USA.
Med. 2021 Aug 13;2(8):979-992.e8. doi: 10.1016/j.medj.2021.06.007. Epub 2021 Jun 29.
Two US Food and Drug Administration (FDA)-authorized coronavirus disease 2019 (COVID-19) mRNA vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna), have demonstrated high efficacy in large phase 3 randomized clinical trials. It is important to assess their effectiveness in a real-world setting.
This is a retrospective analysis of 136,532 individuals in the Mayo Clinic health system (Arizona, Florida, Iowa, Minnesota, and Wisconsin) with PCR testing data between December 1, 2020 and April 20, 2021. We compared clinical outcomes for a vaccinated cohort of 68,266 individuals who received at least one dose of either vaccine (n = 51,795; n = 16,471) and an unvaccinated control cohort of 68,266 individuals propensity matched based on relevant demographic, clinical, and geographic features. We estimated real-world vaccine effectiveness by comparing incidence rates of positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR testing and COVID-19-associated hospitalization and intensive care unit (ICU) admission starting 7 days after the second vaccine dose.
The real-world vaccine effectiveness of preventing SARS-CoV-2 infection was 86.1% (95% confidence interval [CI]: 82.4%-89.1%) for BNT162b2 and 93.3% (95% CI: 85.7%-97.4%) for mRNA-1273. BNT162b2 and mRNA-1273 were 88.8% (95% CI: 75.5%-95.7%) and 86.0% (95% CI: 71.6%-93.9%) effective in preventing COVID-19-associated hospitalization. Both vaccines were 100% effective (95% CI: 51.4%-100%; 95% CI: 43.3%-100%) in preventing COVID-19-associated ICU admission.
BNT162b2 and mRNA-1273 are effective in a real-world setting and are associated with reduced rates of SARS-CoV-2 infection and decreased burden of COVID-19 on the healthcare system.
This study was funded by nference.
两款获得美国食品药品监督管理局（FDA）授权的 2019 年冠状病毒病（COVID-19）mRNA 疫苗，BNT162b2（辉瑞/生物技术公司）和 mRNA-1273（Moderna），在大型 3 期随机临床试验中显示出了很高的疗效。在真实环境中评估它们的效果很重要。
这是对梅奥诊所医疗系统（亚利桑那州、佛罗里达州、爱荷华州、明尼苏达州和威斯康星州）的 136532 个人进行的一项回顾性分析，他们的 PCR 检测数据介于 2020 年 12 月 1 日至 2021 年 4 月 20 日之间。我们比较了接种疫苗组（n=51795 人；n=16471 人）和未接种疫苗对照组（n=68266 人）的临床结果，接种疫苗组至少接受了一剂两种疫苗中的一种，对照组基于相关的人口统计学、临床和地理特征进行了倾向性匹配。我们通过比较第二剂疫苗接种后 7 天开始的 SARS-CoV-2 阳性 PCR 检测以及 COVID-19 相关住院和重症监护病房（ICU）入院的发生率，来估计真实世界的疫苗有效性。
BNT162b2 预防 SARS-CoV-2 感染的真实世界疫苗有效性为 86.1%（95%置信区间[CI]：82.4%-89.1%），mRNA-1273 为 93.3%（95% CI：85.7%-97.4%）。BNT162b2 和 mRNA-1273 预防 COVID-19 相关住院的有效性分别为 88.8%（95% CI：75.5%-95.7%）和 86.0%（95% CI：71.6%-93.9%）。两种疫苗在预防 COVID-19 相关 ICU 入院方面的有效性均为 100%（95% CI：51.4%-100%；95% CI：43.3%-100%）。
BNT162b2 和 mRNA-1273 在真实环境中是有效的，与降低 SARS-CoV-2 感染率和减轻 COVID-19 对医疗系统的负担有关。
本研究由 nference 资助。
