Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study,The Lancet

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Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study
The Lancet ( IF 168.9 ) Pub Date : 2021-10-29 , DOI: 10.1016/s0140-6736(21)02249-2
Noam Barda ₁ , Noa Dagan ₁ , Cyrille Cohen ₂ , Miguel A Hernán ₃ , Marc Lipsitch ₄ , Isaac S Kohane ₅ , Ben Y Reis ₆ , Ran D Balicer ₇

Affiliation

Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv, Israel; Software and Information Systems Engineering, Ben Gurion University of the Negev, Be'er Sheva, Israel; Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA; The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute, Boston, MA, USA.
The Goodman Faculty of Life Sciences, Bar-Ilan University, Ramat Gan, Israel.
Department of Epidemiology, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; CAUSALab, Harvard T H Chan School of Public Health, Boston, MA, USA.
Department of Epidemiology, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Center for Communicable Disease Dynamics, Harvard T H Chan School of Public Health, Boston, MA, USA.
Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA; The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute, Boston, MA, USA; Predictive Medicine Group, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv, Israel; School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel; The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute, Boston, MA, USA.

Background

Many countries are experiencing a resurgence of COVID-19, driven predominantly by the delta (B.1.617.2) variant of SARS-CoV-2. In response, these countries are considering the administration of a third dose of mRNA COVID-19 vaccine as a booster dose to address potential waning immunity over time and reduced effectiveness against the delta variant. We aimed to use the data repositories of Israel's largest health-care organisation to evaluate the effectiveness of a third dose of the BNT162b2 mRNA vaccine for preventing severe COVID-19 outcomes.

Methods

Using data from Clalit Health Services, which provides mandatory health-care coverage for over half of the Israeli population, individuals receiving a third vaccine dose between July 30, 2020, and Sept 23, 2021, were matched (1:1) to demographically and clinically similar controls who did not receive a third dose. Eligible participants had received the second vaccine dose at least 5 months before the recruitment date, had no previous documented SARS-CoV-2 infection, and had no contact with the health-care system in the 3 days before recruitment. Individuals who are health-care workers, live in long-term care facilities, or are medically confined to their homes were excluded. Primary outcomes were COVID-19-related admission to hospital, severe disease, and COVID-19-related death. The third dose effectiveness for each outcome was estimated as 1 – risk ratio using the Kaplan-Meier estimator.

Findings

1 158 269 individuals were eligible to be included in the third dose group. Following matching, the third dose and control groups each included 728 321 individuals. Participants had a median age of 52 years (IQR 37–68) and 51% were female. The median follow-up time was 13 days (IQR 6–21) in both groups. Vaccine effectiveness evaluated at least 7 days after receipt of the third dose, compared with receiving only two doses at least 5 months ago, was estimated to be 93% (231 events for two doses vs 29 events for three doses; 95% CI 88–97) for admission to hospital, 92% (157 vs 17 events; 82–97) for severe disease, and 81% (44 vs seven events; 59–97) for COVID-19-related death.

Interpretation

Our findings suggest that a third dose of the BNT162b2 mRNA vaccine is effective in protecting individuals against severe COVID-19-related outcomes, compared with receiving only two doses at least 5 months ago.

Funding

The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

中文翻译：

第三剂 BNT162b2 mRNA COVID-19 疫苗在以色列预防严重后果的有效性：一项观察性研究

背景

许多国家正在经历 COVID-19 的死灰复燃，这主要是由 SARS-CoV-2 的 delta (B.1.617.2) 变体驱动的。作为回应，这些国家正在考虑使用第三剂 mRNA COVID-19 疫苗作为加强剂，以解决随着时间的推移潜在的免疫力减弱和对 delta 变体的有效性降低的问题。我们旨在使用以色列最大的医疗保健组织的数据存储库来评估第三剂 BNT162b2 mRNA 疫苗预防严重 COVID-19 结果的有效性。

方法

Clalit Health Services 为超过半数的以色列人口提供强制性医疗保险，该机构使用来自该机构的数据，将在 2020 年 7 月 30 日至 2021 年 9 月 23 日期间接种第三剂疫苗的个人与人口统计学和没有接受第三次剂量的临床相似对照。符合条件的参与者在招募日期前至少 5 个月接受了第二剂疫苗，之前没有 SARS-CoV-2 感染记录，并且在招募前 3 天内没有接触过医疗保健系统。卫生保健工作者、住在长期护理机构或在医疗上被限制在家中的个人被排除在外。主要结局是与 COVID-19 相关的入院、严重疾病和与 COVID-19 相关的死亡。

发现

1 158 269 人有资格被纳入第三剂量组。匹配后，第三剂量组和对照组各包括 728 321 人。参与者的中位年龄为 52 岁 (IQR 37–68)，51% 为女性。两组的中位随访时间均为 13 天（IQR 6-21）。与至少 5 个月前仅接受两剂相比，在接受第三剂后至少 7 天评估的疫苗有效性估计为 93%（两剂 231 起事件对比三剂 29 起事件；95% CI 88– 97) 入院，92%（157对17 事件；82-97）为严重疾病，81%（44对7 事件；59-97）与 COVID-19 相关的死亡。