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辉瑞-BioNTech 疫苗加强针在各年龄段对预防新冠病毒的保护作用

Protection against Covid-19 by BNT162b2 Booster across Age Groups.

机构信息

From the Department of Plant and Environmental Sciences, Weizmann Institute of Science, Rehovot (Y.M.B.-O., R.M.), Technion-Israel Institute of Technology, Haifa (Y.G.), the Department of Statistics and Data Science, Hebrew University of Jerusalem (M.M.), and Israel Ministry of Health (O.B., S.A.-P., N.A.), Jerusalem, the Biostatistical and Biomathematical Unit, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat Gan (L.F., A.H.), and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (L.F., A.H.) - all in Israel.

出版信息

N Engl J Med. 2021 Dec 23;385(26):2421-2430. doi: 10.1056/NEJMoa2115926. Epub 2021 Dec 8.

Abstract

BACKGROUND

After promising initial results from the administration of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) to persons 60 years of age or older, the booster campaign in Israel was gradually expanded to persons in younger age groups who had received a second dose at least 5 months earlier.

METHODS

We extracted data for the period from July 30 to October 10, 2021, from the Israel Ministry of Health database regarding 4,696,865 persons 16 years of age or older who had received two doses of BNT162b2 at least 5 months earlier. In the primary analysis, we compared the rates of confirmed coronavirus disease 2019 (Covid-19), severe illness, and death among those who had received a booster dose at least 12 days earlier (booster group) with the rates among those who had not received a booster (nonbooster group). In a secondary analysis, we compared the rates in the booster group with the rates among those who had received a booster 3 to 7 days earlier (early postbooster group). We used Poisson regression models to estimate rate ratios after adjusting for possible confounding factors.

RESULTS

The rate of confirmed infection was lower in the booster group than in the nonbooster group by a factor of approximately 10 (range across five age groups, 9.0 to 17.2) and was lower in the booster group than in the early postbooster group by a factor of 4.9 to 10.8. The adjusted rate difference ranged from 57.0 to 89.5 infections per 100,000 person-days in the primary analysis and from 34.4 to 38.3 in the secondary analysis. The rates of severe illness in the primary and secondary analyses were lower in the booster group by a factor of 17.9 (95% confidence interval [CI], 15.1 to 21.2) and 6.5 (95% CI, 5.1 to 8.2), respectively, among those 60 years of age or older and by a factor of 21.7 (95% CI, 10.6 to 44.2) and 3.7 (95% CI, 1.3 to 10.2) among those 40 to 59 years of age. The adjusted rate difference in the primary and secondary analyses was 5.4 and 1.9 cases of severe illness per 100,000 person-days among those 60 years of age or older and 0.6 and 0.1 among those 40 to 59 years of age. Among those 60 years of age or older, mortality was lower by a factor of 14.7 (95% CI, 10.0 to 21.4) in the primary analysis and 4.9 (95% CI, 3.1 to 7.9) in the secondary analysis. The adjusted rate difference in the primary and secondary analyses was 2.1 and 0.8 deaths per 100,000 person-days.

CONCLUSIONS

Across the age groups studied, rates of confirmed Covid-19 and severe illness were substantially lower among participants who received a booster dose of the BNT162b2 vaccine than among those who did not.

摘要

背景

在辉瑞-生物科技公司(Pfizer-BioNTech)信使 RNA 疫苗(BNT162b2)的第三剂(加强针)给药初步结果令人振奋后,以色列的加强针接种活动逐渐扩大到至少在 5 个月前接种过第二剂的较年轻年龄组人群。

方法

我们从以色列卫生部数据库中提取了 2021 年 7 月 30 日至 10 月 10 日期间的数据,涉及至少 5 个月前接种过两剂 BNT162b2 的 16 岁及以上的 4696865 人。在主要分析中,我们比较了至少 12 天前接受加强针接种者(加强针组)与未接受加强针接种者(未加强针组)的确诊 2019 冠状病毒病(Covid-19)、重症和死亡的发生率。在二次分析中,我们比较了加强针组与 3 至 7 天前接受加强针接种者(早期加强针后组)的发生率。我们使用泊松回归模型,在调整了可能的混杂因素后,估计了比率比。

结果

在调整了潜在混杂因素后,与未加强针组相比,加强针组确诊感染的发生率低约 10 倍(5 个年龄组的范围为 9.0 至 17.2),与早期加强针后组相比,低约 4.9 至 10.8 倍。主要分析中,调整后的发病率差异为每 100000 人日 57.0 至 89.5 例,次要分析中为 34.4 至 38.3 例。在主要和次要分析中,60 岁及以上人群中,重症发生率分别降低了 17.9 倍(95%置信区间[CI],15.1 至 21.2)和 6.5 倍(95%CI,5.1 至 8.2),40 至 59 岁人群中分别降低了 21.7 倍(95%CI,10.6 至 44.2)和 3.7 倍(95%CI,1.3 至 10.2)。主要和次要分析中,60 岁及以上人群的调整发病率差异为每 100000 人日 5.4 至 1.9 例重症,40 至 59 岁人群为 0.6 至 0.1 例。在 60 岁及以上人群中,死亡率在主要分析中降低了 14.7 倍(95%CI,10.0 至 21.4),在次要分析中降低了 4.9 倍(95%CI,3.1 至 7.9)。主要和次要分析中,调整后的发病率差异分别为每 100000 人日 2.1 和 0.8 例死亡。

结论

在研究的年龄组中,与未接种加强针的人群相比,接种 BNT162b2 疫苗加强针的人群中确诊的 Covid-19 和重症的发生率明显降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/075a/8728796/bfec48eaeb1c/NEJMoa2115926_f1.jpg

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