Adverse Events Reported From COVID-19 Vaccine Trials: A Systematic Review.
Adverse Events Reported From COVID-19 Vaccine Trials: A Systematic Review.
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DOI：
10.1007/s12291-021-00968-z
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Misra S
中科院分区：
文献类型：
--
作者：
Kaur RJ;Dutta S;Bhardwaj P;Charan J;Dhingra S;Mitra P;Singh K;Yadav D;Sharma P;Misra S
COVID-19感染于二零一九年十二月起源于中国武汉，并立即在全球范围内损害人类健康。公共卫生紧急情况需要紧急努力开发和测试疫苗的有效性和安全性，以应对COVID-19大流行。COVID-19疫苗在常规临床试验阶段完成前已获得紧急使用批准。然而，并无对疫苗试验报告的安全性数据进行全面审查，而该等数据为政策提供重要信息，以提高COVID-19疫苗的使用率及减轻因COVID-19疫苗副作用而产生的风险规避。本研究旨在系统地回顾和综合已发表的COVID-19疫苗试验的安全性数据证据。本研究遵循PRISMA指南。我们检索了三个主要的电子数据库（PubMed、Embase和Google Scholar），以查找2019年12月至2020年期间发表的研究。合格的研究设计是随机试验和干预前后的评估。按照目标人群、环境、结局和总体结果分层报告纳入研究的描述性结果。从PubMed、Embase、WHO数据库和Google Scholar筛选的标题和摘要中，本综述确定了11项研究。报告的大多数反应为轻度至中度，少数为重度。所有反应均在3-4天内消退。通常报告的局部不良事件为注射部位疼痛、肿胀和发红。全身反应包括发热、疲乏、肌痛和头痛。一些试验还报告了实验室紊乱，如血红蛋白降低、胆红素升高、SGOT和SGPT改变。这些变化均无临床表现，且具有自限性。很少有临床试验报告了严重的不良事件，但它们与疫苗接种无关。这项系统性综述表明，COVID-19疫苗是安全的，没有严重的不良事件。然而，长期的上市后监测数据，特别是在高风险脆弱人群（老年人和合并症患者、孕妇和儿童）中的数据，是确保COVID-19疫苗安全性的必要条件。
COVID-19 infection originated in Wuhan, China in December 2019 and crippled human health globally in no time. The public health emergency required urgent efforts to develop and test the efficacy and safety of vaccines to combat the COVID-19 pandemic. The emergency use approval has been granted to COVID-19 vaccines before the completion of conventional phases of clinical trials. However, there is no comprehensive review of safety data reported from the vaccine trials, which is critical information to inform the policies in order to improve uptake of COVID-19 vaccines and mitigate the risk aversion perceived due to the COVID-vaccine side effects. This study aims to systematically review and synthesize the evidence on the safety data from the published COVID-19 vaccine trials. This study followed PRISMA guidelines. We searched three major electronic databases (PubMed, Embase, and Google Scholar) for published studies between Dec 2019 and 2020. Eligible study designs were randomized trials and pre-and post-intervention evaluations. Descriptive findings of included studies were reported stratified by target population, setting, outcomes, and overall results. From PubMed, Embase, WHO database, and Google Scholar screened titles and abstracts, 11 studies were identified in this review. Most of the reactions reported were mild to moderate whereas a few with severe intensity. All reactions resolved within 3–4 days. The commonly reported local adverse events were pain at the site of injection, swelling, and redness. The systemic reactions included fever, fatigue, myalgia, and headache. Some trials also reported laboratory derangements like decreased hemoglobin, increased bilirubin, altered SGOT and SGPT. None of these alterations were clinically manifested and were self-limiting. Few clinical trials reported serious adverse events, but they were unrelated to vaccination. This systematic review indicates that COVID-19 vaccines can be safe with no serious adverse events. However, long-term post-marketing surveillance data, particularly in high-risk vulnerable populations (elderly and those with co-morbidities, pregnant women, and children) is warranted to ensure the safety of COVID-19 vaccines.
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DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
影响因子：
15.8
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
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：
158.5
作者：
Keech, Cheryl;Albert, Gary;Glenn, Gregory M.
通讯作者：
Glenn, Gregory M.
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