A comprehensive analysis of the efficacy and safety of COVID-19 vaccines.
A comprehensive analysis of the efficacy and safety of COVID-19 vaccines.
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COVID-19疫苗的有效性和安全性的全面分析
DOI：
10.1016/j.ymthe.2021.08.001
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发表时间：
2021-09-01
期刊：
影响因子：
--
通讯作者：
Shen H
中科院分区：
文献类型：
--
作者：
Cai C;Peng Y;Shen E;Huang Q;Chen Y;Liu P;Guo C;Feng Z;Gao L;Zhang X;Gao Y;Liu Y;Han Y;Zeng S;Shen H
2019冠状病毒病（COVID-19）的病例和死亡人数持续增加。许多人担心COVID-19疫苗的有效性和安全性。我们对已发表的COVID-19疫苗试验和疫苗不良事件报告系统的真实数据进行了全面分析。在全球范围内，我们的研究发现，所有疫苗的效力均超过70%，其中rna疫苗的效力最高，为94.29%；此外，黑人或非裔美国人、年轻人和男性可能体验到更大的疫苗效力。疫苗相关药物不良反应（adr）的范围非常广泛，最常见的adr是疼痛、疲劳和头痛。大多数不良反应是可容忍的，严重程度主要为1级或2级。已经确定了一些严重的不良反应（血栓栓塞事件，每百万剂量21-75例；心肌炎/心包炎，每百万剂量2-3例）。总之，疫苗是一种强大的工具，可用于控制COVID-19大流行，具有高疗效和可耐受的不良反应。此外，与疫苗相关的不良反应范围很广，大多数反应在一周内出现，尽管有些反应可能会延迟。因此，需要及时发现和处理疫苗接种后的不良反应。新冠肺炎病例和死亡人数持续增加。Cai等人首次全面分析了现有COVID-19疫苗的疗效以及与COVID-19疫苗相关的不良反应发生率、范围、时间、临床特征，可为公众提供参考。
The numbers of cases and deaths from coronavirus disease 2019 (COVID-19) are continuously increasing. Many people are concerned about the efficacy and safety of the COVID-19 vaccines. We performed a comprehensive analysis of the published trials of COVID-19 vaccines and the real-world data from the Vaccine Adverse Event Reporting System. Globally, our research found that the efficacy of all vaccines exceeded 70%, and RNA-based vaccines had the highest efficacy of 94.29%; moreover, Black or African American people, young people, and males may experience greater vaccine efficacy. The spectrum of vaccine-related adverse drug reactions (ADRs) is extremely broad, and the most frequent ADRs are pain, fatigue, and headache. Most ADRs are tolerable and are mainly grade 1 or 2 in severity. Some severe ADRs have been identified (thromboembolic events, 21–75 cases per million doses; myocarditis/pericarditis, 2–3 cases per million doses). In summary, vaccines are a powerful tool that can be used to control the COVID-19 pandemic, with high efficacy and tolerable ADRs. In addition, the spectrum of ADRs associated with the vaccines is broad, and most of the reactions appear within a week, although some may be delayed. Therefore, ADRs after vaccination need to be identified and addressed in a timely manner. The numbers of cases and deaths from COVID-19 are continuously increasing. Cai et al. are the first to comprehensively analyze the efficacy of the existing COVID-19 vaccines and the incidence, spectrum, timing, and clinical features of adverse reactions associated with the COVID-19 vaccines, which can provide reference for general public.
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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：
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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
DOI：
10.1136/bmj.i2716
发表时间：
2016-06-14
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Aune D;Keum N;Giovannucci E;Fadnes LT;Boffetta P;Greenwood DC;Tonstad S;Vatten LJ;Riboli E;Norat T
通讯作者：
Norat T
影响因子：
158.5
作者：
Keech, Cheryl;Albert, Gary;Glenn, Gregory M.
通讯作者：
Glenn, Gregory M.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
DOI：
10.1056/nejmoa2101544
发表时间：
2021-06-10
期刊：
The New England journal of medicine
影响因子：
--
作者：
Sadoff J;Gray G;Vandebosch A;Cárdenas V;Shukarev G;Grinsztejn B;Goepfert PA;Truyers C;Fennema H;Spiessens B;Offergeld K;Scheper G;Taylor KL;Robb ML;Treanor J;Barouch DH;Stoddard J;Ryser MF;Marovich MA;Neuzil KM;Corey L;Cauwenberghs N;Tanner T;Hardt K;Ruiz-Guiñazú J;Le Gars M;Schuitemaker H;Van Hoof J;Struyf F;Douoguih M;ENSEMBLE Study Group
通讯作者：
ENSEMBLE Study Group