Assessment of Effectiveness of 1 Dose of BNT162b2 Vaccine for SARS-CoV-2 Infection 13 to 24 Days After Immunization.
Assessment of Effectiveness of 1 Dose of BNT162b2 Vaccine for SARS-CoV-2 Infection 13 to 24 Days After Immunization.
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DOI：
10.1001/jamanetworkopen.2021.15985
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发表时间：
2021-06-01
影响因子：
13.8
通讯作者：
Muhsen K
中科院分区：
文献类型：
--
作者：
Chodick G;Tene L;Patalon T;Gazit S;Ben Tov A;Cohen D;Muhsen K
在现实世界中，1剂BNT162b2新冠肺炎疫苗是否与预防感染SARS-CoV-2和有症状的新冠肺炎有关？在这项对503名接受1剂BNT162b2疫苗的 875人的比较有效性研究中，第一剂疫苗与接种后13至24天的SARS-CoV-2感染风险比接种后1至12天的风险降低了约51%。第一次注射对有症状的新冠肺炎有54%的有效率。这项研究的结果与第三阶段随机临床试验中报告的1剂疫苗的疗效一致。这项有效性比较研究考察了在现实世界中接种1剂BNT162b2新冠肺炎疫苗的有效性。在III期随机临床试验中，BNT162b2疫苗对新冠肺炎显示出高效性。需要在现实世界环境中进行疫苗效力评估。评估BNT162b2疫苗在真实世界环境中免疫13至24天后首针预防SARS-CoV-2感染的短期效果。这项有效性比较研究使用了来自以色列260万个国家强制医疗保健系统的数据。参与者包括所有在2020年12月19日至2021年1月15日期间接种1剂BNT162b2疫苗的16岁及以上的个人。对2021年3月的数据进行了分析。接种1剂BNT162b2疫苗。收集从第一次接种疫苗后1天到2021年1月17日的病史、SARS-CoV-2聚合酶链式反应阳性和新冠肺炎症状的信息。使用Kaplan-Meier生存分析和广义线性模型比较第13-24天和第1-12天的日感染率和累积感染率。分析了503名 875人(平均年龄59.7[14.7]岁；263名 228[52.4%]女性)的数据，其中351名 897有第13至24天的随访数据。第1至12天SARS-CoV-2累计感染率为2484人(0.57%)，第13至24天为614人(0.27%)。第1~12天SARS-CoV2感染的加权平均日发病率为43.41(12.07)个/10万 ，第13~24天为21.08(6.16)个/10万 ，相对危险度降低51.4%(95%CI，16.3%~71.8%)。从第一次服药后第18天起，发病率明显下降。60岁以上(44.5%；95%CI，4.1%-67.9%)、60岁以下(50.2%；95%CI，14.1%-71.2%)、女性(50.0%；95%CI，13.5%-71.0%)和男性(52.1%；95%CI，17.3%-72.2%)有类似的RRR。在亚群中(例如，极端正统犹太人：RRR，53.5%[95%CI，19.2%-73.2%])和各种合并症患者(例如，心血管疾病：RRR，47.2%[95%CI，7.8%-69.8%])的结果相似。疫苗对症状性新冠肺炎的有效率为54.4%(95%CI，21.4%~73.6%)。在这项单剂BNT162b2疫苗的比较有效性研究中，结果与III期随机临床试验的结果相当。
Is 1 dose of the BNT162b2 COVID-19 mRNA vaccine associated with protection against infection with SARS-CoV-2 and symptomatic COVID-19 in real-world settings? In this comparative effectiveness study of 503 875 individuals who received 1 dose of the BNT162b2 vaccine, the first dose of the vaccine was associated with an approximately 51% reduction in the risk of SARS-CoV-2 infections at 13 to 24 days after immunization compared with 1 to 12 days after vaccination. The first dose was associated with 54% effectiveness against symptomatic COVID-19. The results of this study agree with vaccine efficacy as reported in the phase III randomized clinical trial after 1 dose. This comparative effectiveness study examines the effectiveness associated with 1 dose of the BNT162b2 COVID-19 vaccine in a real-world setting. The BNT162b2 vaccine showed high efficacy against COVID-19 in a phase III randomized clinical trial. A vaccine effectiveness evaluation in a real-world setting is needed. To assess the short-term effectiveness of the first dose of the BNT162b2-vaccine against SARS-CoV-2 infection 13 to 24 days after immunization in a real-world setting. This comparative effectiveness study used data from a 2.6 million-member state-mandated health care system in Israel. Participants included all individuals aged 16 years and older who received 1 dose of the BNT162b2 vaccine between December 19, 2020, and January 15, 2021. Data were analyzed in March 2021. Receipt of 1 dose of the BNT162b2 vaccine. Information was collected regarding medical history and positive SARS-CoV-2 polymerase chain reaction test and COVID-19 symptoms from 1 day after first vaccine to January 17, 2021. Daily and cumulative infection rates in days 13 to 24 were compared with days 1 to 12 after the first dose using Kaplan-Meier survival analysis and generalized linear models. Data for 503 875 individuals (mean [SD] age, 59.7 [14.7] years; 263 228 [52.4%] women) were analyzed, of whom 351 897 had follow-up data for days 13 to 24. The cumulative incidence of SARS-CoV-2 infection was 2484 individuals (0.57%) during days 1 through 12 and 614 individuals (0.27%) in days 13 through 24. The weighted mean (SE) daily incidence of SARS-CoV-2 infection in days 1 through 12 was 43.41 (12.07) infections per 100 000 population and 21.08 (6.16) infections per 100 000 population in days 13 through 24, a relative risk reduction (RRR) of 51.4% (95% CI, 16.3%-71.8%). The decrease in incidence was evident from day 18 after the first dose. Similar RRRs were calculated in individuals aged 60 years or older (44.5%; 95% CI, 4.1%-67.9%), those younger than 60 years (50.2%; 95% CI, 14.1%-71.2%), women (50.0%; 95% CI, 13.5%-71.0%), and men (52.1%; 95% CI, 17.3%-72.2%). Findings were similar in subpopulations (eg, ultraorthodox Jewish: RRR, 53.5% [95% CI, 19.2%-73.2%]) and patients with various comorbidities (eg, cardiovascular diseases: RRR, 47.2% [95% CI, 7.8%-69.8%]). Vaccine effectiveness against symptomatic COVID-19 was 54.4% (95% CI, 21.4%-73.6%). In this comparative effectiveness study of a single dose of the BNT162b2 vaccine, results were comparable to that of the phase III randomized clinical trial.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
5.5
作者：
Jackson, Michael L.;Phillips, C. Hallie;Jackson, Lisa A.
通讯作者：
Jackson, Lisa A.
影响因子：
3.5
作者：
Shalev, Varda;Chodick, Gabriel;Heymann, Anthony D.
通讯作者：
Heymann, Anthony D.
DOI：
10.1016/s0140-6736(21)00085-4
发表时间：
2021-01-30
期刊：
Lancet (London, England)
影响因子：
--
作者：
Cavaleri M;Enzmann H;Straus S;Cooke E
通讯作者：
Cooke E
影响因子：
13.6
作者：
Chodick, G;Heymann, AD;Kookia, E
通讯作者：
Kookia, E