From the Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv (N.D., N.B., E.K., O.M., S.P., M.A.K., R.D.B.), and the School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva (O.M., M.A.K., R.D.B.) - both in Israel; University of Michigan School of Public Health, Ann Arbor (M.A.K.); and the Department of Biomedical Informatics (N.D., N.B.), Harvard Medical School (B.R.), the Departments of Epidemiology and Biostatistics (M.A.H.), and the Center for Communicable Disease Dynamics, Departments of Epidemiology and of Immunology and Infectious Diseases (M.L.), Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology (M.A.H.), and the Predictive Medicine Group, Computational Health Informatics Program, Boston Children's Hospital (B.R.) - all in Boston.
N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24.
As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine.
All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19-related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan-Meier estimator.
Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions.
This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19-related outcomes, a finding consistent with that of the randomized trial.
随着全球范围内针对 2019 年冠状病毒病（COVID-19）的大规模疫苗接种运动的开展，需要在非对照环境中针对不同人群的一系列结果来评估疫苗的有效性。在这项研究中，使用了以色列最大的医疗保健组织的数据来评估 BNT162b2 mRNA 疫苗的有效性。
在 2020 年 12 月 20 日至 2021 年 2 月 1 日期间，所有新接种疫苗的人都根据人口统计学和临床特征与未接种疫苗的对照者按 1:1 比例进行匹配。研究结果包括有记录的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染、有症状的 COVID-19、COVID-19 相关住院、重症和死亡。我们使用 Kaplan-Meier 估计法，将每个结果的风险比减去 1 来估计疫苗的有效性。
每个研究组都包括 596618 人。在第一次接种后 14 至 20 天和第二次接种后 7 天或更长时间，对研究结果的疫苗有效性估计如下：有记录的感染，46%（95%置信区间[CI]，40 至 51）和 92%（95%CI，88 至 95）；有症状的 COVID-19，57%（95%CI，50 至 63）和 94%（95%CI，87 至 98）；住院治疗，74%（95%CI，56 至 86）和 87%（95%CI，55 至 100）；重症疾病，62%（95%CI，39 至 80）和 92%（95%CI，75 至 100）。在第一次接种后 14 至 20 天，预防 COVID-19 死亡的估计有效性为 72%（95%CI，19 至 100）。在有记录的感染和有症状的 COVID-19 评估的特定亚人群中，有效性在年龄组之间是一致的，在患有多种共存疾病的人群中，有效性可能略低。
这项在全国性大规模疫苗接种环境中进行的研究表明，BNT162b2 mRNA 疫苗对广泛的 COVID-19 相关结果有效，这一发现与随机试验一致。
Zotero 插件