Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile.

Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile.
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DOI:
10.1056/nejmoa2107715
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发表时间:
2021-09-02
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
Araos R
Araos R
中科院分区:
其他
文献类型:
--
作者:
Jara A;Undurraga EA;González C;Paredes F;Fontecilla T;Jara G;Pizarro A;Acevedo J;Leo K;Leon F;Sans C;Leighton P;Suárez P;García-Escorza H;Araos R

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许多国家正在开展预防2019年冠状病毒病的大规模疫苗接种运动(新冠肺炎);迫切需要对疫苗效力进行评估,以支持决策。智利从2021年2月2日开始在全国范围内开展使用SARS-CoV-2灭活疫苗(CoronaVac)的大规模疫苗接种活动。我们使用了一个预期的国家队列,包括隶属于国家公共卫生保健系统的16岁或16岁以上的参与者,以评估SARS-CoV-2灭活疫苗在预防新冠肺炎和相关住院、进入重症监护病房(ICU)和死亡方面的有效性。我们使用扩展的COX比例风险模型来估计风险比,考虑到疫苗接种状态的时变性。我们估计了与部分免疫(≥在接受第一剂疫苗后14天和在接受第二剂疫苗之前)和完全免疫(≥在收到第二剂疫苗后14天)相关的风险比率的变化。疫苗有效性的评估是根据个人人口统计和临床特征进行调整的。这项研究于2021年2月2日至5月1日进行,队列包括约1020万人。在充分接种疫苗的人群中,预防新冠肺炎的调整疫苗有效率为65.9%(95%可信区间,65.2~66.6),预防住院的调整疫苗有效率为87.5%(95%CI,86.7~88.2),预防重症监护病房的调整疫苗有效率为90.3%(95%CI,89.1~91.4),预防新冠肺炎相关死亡的调整疫苗有效率为86.3%(95%CI,84.5~87.9)。我们的结果表明,SARS-CoV-2灭活疫苗有效地预防了新冠肺炎,包括严重疾病和死亡,这一发现与疫苗第二阶段试验的结果一致。(由Agencia Nacional de Investigación y Desarroll和其他人资助。)
Mass vaccination campaigns to prevent coronavirus disease 2019 (Covid-19) are occurring in many countries; estimates of vaccine effectiveness are urgently needed to support decision making. A countrywide mass vaccination campaign with the use of an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (CoronaVac) was conducted in Chile starting on February 2, 2021. We used a prospective national cohort, including participants 16 years of age or older who were affiliated with the public national health care system, to assess the effectiveness of the inactivated SARS-CoV-2 vaccine with regard to preventing Covid-19 and related hospitalization, admission to the intensive care unit (ICU), and death. We estimated hazard ratios using the extension of the Cox proportional-hazards model, accounting for time-varying vaccination status. We estimated the change in the hazard ratio associated with partial immunization (≥14 days after receipt of the first dose and before receipt of the second dose) and full immunization (≥14 days after receipt of the second dose). Vaccine effectiveness was estimated with adjustment for individual demographic and clinical characteristics. The study was conducted from February 2 through May 1, 2021, and the cohort included approximately 10.2 million persons. Among persons who were fully immunized, the adjusted vaccine effectiveness was 65.9% (95% confidence interval [CI], 65.2 to 66.6) for the prevention of Covid-19 and 87.5% (95% CI, 86.7 to 88.2) for the prevention of hospitalization, 90.3% (95% CI, 89.1 to 91.4) for the prevention of ICU admission, and 86.3% (95% CI, 84.5 to 87.9) for the prevention of Covid-19–related death. Our results suggest that the inactivated SARS-CoV-2 vaccine effectively prevented Covid-19, including severe disease and death, a finding that is consistent with results of phase 2 trials of the vaccine. (Funded by Agencia Nacional de Investigación y Desarrollo and others.)