BNT162b2 Messenger RNA COVID-19 Vaccine Effectiveness in Patients With Inflammatory Bowel Disease: Preliminary Real-World Data During Mass Vaccination Campaign.
BNT162b2 Messenger RNA COVID-19 Vaccine Effectiveness in Patients With Inflammatory Bowel Disease: Preliminary Real-World Data During Mass Vaccination Campaign.
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DOI：
10.1053/j.gastro.2021.06.076
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发表时间：
2021-11
期刊：
影响因子：
29.4
通讯作者：
Collaborators of the Maccabi Institute for Research & Innovation COVID-19 Task Force
中科院分区：
文献类型：
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作者：
Ben-Tov A;Banon T;Chodick G;Kariv R;Assa A;Gazit S;Collaborators of the Maccabi Institute for Research & Innovation COVID-19 Task Force
纽约）在一项III期安慰剂对照随机临床试验1和真实世界数据分析中证明了95%的预防COVID-19的有效性。2，3接受免疫调节剂治疗的炎症性肠病（IBD）患者被认为是部分免疫抑制，因此，国际炎症性肠病研究组织（IOIBD）建议IBD患者应接种COVID-19疫苗，接受免疫调节治疗的患者不应推迟接种疫苗。4由于患有免疫疾病（包括IBD）的患者被排除在COVID-19疫苗临床试验之外，因此描述积累的真实世界数据非常重要。在以色列，IBD患者在该运动中优先获得早期疫苗接种，截至2021年6月23日，这是全球范围内最广泛的（总人口的63.6%至少接种了2剂疫苗，59.5%的人口完全接种疫苗）。6本研究是对IBD患者群体接种疫苗效果的初步报告。这项回顾性队列研究使用Maccabi Healthcare Services（MHS）中央计算机数据库的数据进行。MHS是以色列第二大国家授权的医疗保健提供者，覆盖超过250万成员（占人口的25%），是以色列人口的代表性样本。为了评估疫苗的有效性，这项研究包括来自MHS IBD登记处的16岁接受BNT 162 b2 mRNA COVID-19疫苗接种的个体和在2020年12月19日至2021年3月10日期间接种疫苗的匹配患者（1：3）。根据性别、出生年份、共存合并症和首次接种月份进行个体匹配。根据MHS IBD登记研究，基于医生诊断和分发的药物定义IBD状态。7该分析排除了在首次接种BNT 162 b2疫苗前任何时间有阳性聚合酶链反应（PCR）结果或诊断为COVID-19的患者。所有合格的患者都需要在第二次疫苗接种日期（称为“索引日期”）后进行至少30天的随访，以观察研究结果。回顾性随访从索引日期持续至2021年4月11日（详情见补充文本）。MHS伦理委员会批准了研究方案。该研究包括12，231名IBD患者和36，254名匹配患者。总体而言，50.0%为女性，两组的平均年龄为47±17岁。随访的中位数为71天（四分位距，52-80天），疫苗接种间隔的中位数为21天
New York, NY) has demonstrated 95% efficacy in preventing COVID-19 in a phase III placebo-controlled randomized clinical trial1 and in real-world data analyses. 2, 3 Patients with inflammatory bowel disease (IBD) treated with immune-modifying agents are considered partially immunosuppressed, and thus, the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) recommends that patients with IBD should be vaccinated against COVID-19 and that vaccination should not be deferred in patients receiving immune-modifying therapies. 4 Because patients with immune conditions (including IBD) were excluded from the COVID-19 vaccine clinical trials, it is important to describe accumulating real-world data. 5 In Israel, patients with IBD were given priority for early vaccination in the campaign, which is, as of June 23, 2021, the most extensive worldwide (63.6% of the total population received at least 2 doses, and 59.5% of the population was fully vaccinated). 6This study is a preliminary report of the effect of mass vaccination in patients with IBD. This retrospective cohort study was conducted using data from the Maccabi Healthcare Services (MHS) central computerized database. MHS is the second largest statemandated health care provider in Israel, covering> 2.5 million members (25% of the population) and is a representative sample of the Israeli population. To evaluate vaccine effectiveness, this study included individuals from the MHS IBD registry aged 16 years who received the BNT162b2 mRNA COVID-19 vaccine and matched patients (1: 3) who were vaccinated between December 19, 2020 and March 10, 2021. Individual matching was performed based on sex, birth year, coexisting comorbidities, and month of the first vaccination dose. IBD status was defined according to the MHS IBD registry based on physician diagnosis and dispensed medications. 7 The analysis excluded patients with a history of a positive polymerase chain reaction (PCR) result or a diagnosis of COVID-19 any time before thefirst BNT162b2 vaccination. All eligible patients were required to have a minimum of 30 days of follow-up after the second vaccine dose date, referred to as the “index date,” to observe study outcomes. Retrospective follow-up lasted from the index date until April 11, 2021 (details are provided in the Supplementary Text). The MHS Ethics Committee approved the study protocol. The study included 12,231 patients with IBD and 36,254 matched patients. Overall, 50.0% were women, and the mean age was 47±17 years in both groups. Follow-up was a median of 71 days (interquartile range, 52–80 days), and the interval between vaccines was a median of 21 days
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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：
29.4
作者：
Wong SY;Dixon R;Martinez Pazos V;Gnjatic S;Colombel JF;Cadwell K;ICARUS-IBD Working Group
通讯作者：
ICARUS-IBD Working Group
影响因子：
24.5
作者：
Siegel CA;Melmed GY;McGovern DP;Rai V;Krammer F;Rubin DT;Abreu MT;Dubinsky MC;International Organization for the Study of Inflammatory Bowel Disease (IOIBD);International Organization for the Study of Inflammatory Bowel Diseases (IOIBD)
通讯作者：
International Organization for the Study of Inflammatory Bowel Diseases (IOIBD)
影响因子：
82.9
作者：
Kim, Jerome H.;Marks, Florian;Clemens, John D.
通讯作者：
Clemens, John D.
DOI：
10.1056/nejmoa2101765
发表时间：
2021-04-15
期刊：
The New England journal of medicine
影响因子：
--
作者：
Dagan N;Barda N;Kepten E;Miron O;Perchik S;Katz MA;Hernán MA;Lipsitch M;Reis B;Balicer RD
通讯作者：
Balicer RD