BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
复制标题
DOI：
10.1056/nejmoa2101765
复制
发表时间：
2021-04-15
期刊：
影响因子：
--
通讯作者：
Balicer RD
中科院分区：
文献类型：
--
作者：
Dagan N;Barda N;Kepten E;Miron O;Perchik S;Katz MA;Hernán MA;Lipsitch M;Reis B;Balicer RD
随着针对 2019 年冠状病毒病 (Covid-19) 的大规模疫苗接种活动在全球范围内展开，需要评估疫苗有效性，以了解非控制环境下不同人群的一系列结果。在这项研究中，来自以色列最大的医疗保健组织的数据被用来评估 BNT162b2 mRNA 疫苗的有效性。根据人口统计学和临床特征，将2020年12月20日至2021年2月1日期间新接种疫苗的所有人员与未接种疫苗的对照者以1:1的比例进行匹配。研究结果包括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、与 Covid-19 相关的住院治疗、重症和死亡。我们使用 Kaplan-Meier 估计量将每种结果的疫苗有效性估计为一减去风险比。每个研究组包括 596,618 人。第一次接种后第 14 至 20 天以及第二次接种后 7 天或更多天时的研究结果的估计疫苗有效性如下：对于有记录的感染，为 46%（95% 置信区间 [CI]，40 至 51）和 92%（95% CI，88 至 95）；对于有症状的 Covid-19，为 57%（95% CI，50 至 63）和 94%（95% CI，87 至 98）；住院治疗的比例为 74%（95% CI，56 至 86）和 87%（95% CI，55 至 100）；对于严重疾病，分别为 62%（95% CI，39 至 80）和 92%（95% CI，75 至 100）。首次给药后第 14 至 20 天，预防 Covid-19 死亡的估计有效性为 72%（95% CI，19 至 100）。在特定亚群中评估记录的感染和有症状的 Covid-19 的估计有效性在各个年龄组中是一致的，而对于患有多种共存疾病的人来说，其有效性可能略低。这项在全国范围内进行大规模疫苗接种的研究表明，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的结果一致。
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.