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BNT162b2 疫苗加强针与新冠病毒导致的死亡率。

BNT162b2 Vaccine Booster and Mortality Due to Covid-19.

机构信息

From the Community Medical Services Division, Clalit Health Services, Tel Aviv (R.A., A.H., A.P., D.N., S.Y.), the Maximizing Health Outcomes Research Lab, Sapir College, Sderot (R.A.), and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beersheba (R.S., M.F.) - all in Israel.

出版信息

N Engl J Med. 2021 Dec 23;385(26):2413-2420. doi: 10.1056/NEJMoa2115624. Epub 2021 Dec 8.

Abstract

BACKGROUND

The emergence of the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 and the reduced effectiveness over time of the BNT162b2 vaccine (Pfizer-BioNTech) led to a resurgence of coronavirus disease 2019 (Covid-19) cases in populations that had been vaccinated early. On July 30, 2021, the Israeli Ministry of Health approved the use of a third dose of BNT162b2 (booster) to cope with this resurgence. Evidence regarding the effectiveness of the booster in lowering mortality due to Covid-19 is still needed.

METHODS

We obtained data for all members of Clalit Health Services who were 50 years of age or older at the start of the study and had received two doses of BNT162b2 at least 5 months earlier. The mortality due to Covid-19 among participants who received the booster during the study period (booster group) was compared with that among participants who did not receive the booster (nonbooster group). A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of booster status with death due to Covid-19, with adjustment for sociodemographic factors and coexisting conditions.

RESULTS

A total of 843,208 participants met the eligibility criteria, of whom 758,118 (90%) received the booster during the 54-day study period. Death due to Covid-19 occurred in 65 participants in the booster group (0.16 per 100,000 persons per day) and in 137 participants in the nonbooster group (2.98 per 100,000 persons per day). The adjusted hazard ratio for death due to Covid-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% confidence interval, 0.07 to 0.14; P<0.001).

CONCLUSIONS

Participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 than participants who did not receive a booster.

摘要

背景

严重急性呼吸综合征冠状病毒 2 型的 B.1.617.2(德尔塔)变体的出现,以及辉瑞-生物技术公司的 BNT162b2 疫苗随着时间推移效力降低,导致早期接种疫苗的人群中 2019 年冠状病毒病(Covid-19)病例再次出现。2021 年 7 月 30 日,以色列卫生部批准使用第三剂 BNT162b2(加强针)来应对这种反弹。仍需要证据来证明加强针在降低因 Covid-19 导致的死亡率方面的有效性。

方法

我们获得了研究开始时年龄在 50 岁及以上且至少在 5 个月前接受了两剂 BNT162b2 的 Clalit 卫生服务所有成员的数据。在研究期间接受加强针的参与者(加强针组)因 Covid-19 导致的死亡率与未接受加强针的参与者(非加强针组)进行了比较。使用具有时间依赖性协变量的 Cox 比例风险回归模型,调整了社会人口统计学因素和并存疾病后,估计了加强针状况与因 Covid-19 导致的死亡之间的关联。

结果

共有 843208 名参与者符合入选标准,其中 758118 名(90%)在 54 天的研究期间接受了加强针。在加强针组中,有 65 名参与者(每 100000 人每天 0.16 人)因 Covid-19 死亡,而非加强针组中有 137 名参与者(每 100000 人每天 2.98 人)。与非加强针组相比,加强针组因 Covid-19 死亡的调整后风险比为 0.10(95%置信区间,0.07 至 0.14;P<0.001)。

结论

在第二剂 BNT162b2 至少 5 个月后接受加强针的参与者因 Covid-19 导致的死亡率比未接受加强针的参与者低 90%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4dd4/8728797/3d97b70a7d0b/NEJMoa2115624_f1.jpg

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