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辉瑞-生物科技疫苗对 SARS-CoV-2 感染的有效性:来自以色列一项大型观察性研究的结果。

Pfizer-BioNTech vaccine effectiveness against Sars-Cov-2 infection: Findings from a large observational study in Israel.

机构信息

Dept. Health Evaluation & Research, Division of Data & Digital Health, Maccabi HealthCare Services, Rehov HaMered 27, Tel Aviv 68125, Israel.

Dept. Health Evaluation & Research, Division of Data & Digital Health, Maccabi HealthCare Services, Rehov HaMered 27, Tel Aviv 68125, Israel.

出版信息

Prev Med. 2022 Feb;155:106947. doi: 10.1016/j.ypmed.2021.106947. Epub 2021 Dec 30.

Abstract

Development of an effective vaccine against Covid-19 is crucial to reducing infection. mRNA BNT162b2, developed and manufactured by Pfizer-BioNTech, was one of the first FDA-approved vaccinations reporting high efficacy (95%) and minimal side effects. Evaluating effectiveness of BNT162b2 in a general population has been made possible after the implementation of a nation-wide vaccination program in Israel. This retrospective cohort study was carried out in Maccabi HealthCare services, Israel among 1.6 million members aged 16 and over. The population was divided into those who were at least seven days post- second vaccination and those who had not been vaccinated. Number of days till the end of the study or Covid-19 infection, Covid-19-related hospitalization and mortality was calculated for each participant between 18.1.2021 to 25.4.2021. Participants who had reached day eight after second vaccination during the study period could contribute days to both groups. Vaccine efficacy (VE) was calculated using a conditional Poisson model, controlling for age group, gender, hypertension, diabetes and obesity, fitted within clusters defined by geographical statistical area and calendar week. BNT162b2 was found effective for the total population group for infection, hospitalization and mortality, with adjusted VE of 93·0% (CI:92·6-93·4%), 93·4% (CI:91·9-94·7%) and 91·1% (CI:86·5-94·1%) respectively. VE for infection was lower for participants aged 75 and over, and for those with hypertension, diabetes and obesity. This study strengthens the evidence that the Pfizer-BioNTech vaccination is effective in preventing infection, hospitalization and mortality.

摘要

开发针对新冠病毒的有效疫苗对于减少感染至关重要。辉瑞-生物科技公司开发和生产的 mRNA BNT162b2 是首批获得美国食品和药物管理局批准的疫苗之一,其有效性(95%)和副作用极小。在以色列实施全国性疫苗接种计划后,评估 BNT162b2 在普通人群中的有效性成为可能。这项回顾性队列研究在以色列的 Maccabi 医疗保健服务中进行,研究对象为 16 岁及以上的 160 万成员。人群分为至少接种第二剂疫苗 7 天的人群和未接种疫苗的人群。从 2021 年 1 月 18 日至 2021 年 4 月 25 日,为每位参与者计算了研究结束或感染新冠病毒、因新冠病毒相关住院和死亡的天数。在研究期间,已经接种第二剂疫苗 8 天的参与者可以为两组提供天数。使用条件泊松模型计算疫苗效力(VE),模型控制了年龄组、性别、高血压、糖尿病和肥胖等因素,并在地理统计区域和日历周定义的聚类中进行拟合。对于感染、住院和死亡,BNT162b2 对总人口均有效,调整后的 VE 分别为 93.0%(92.6-93.4%)、93.4%(91.9-94.7%)和 91.1%(86.5-94.1%)。对于 75 岁及以上的参与者以及高血压、糖尿病和肥胖的参与者,感染的 VE 较低。这项研究加强了辉瑞-生物科技疫苗在预防感染、住院和死亡方面有效的证据。

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