Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: A systematic review.
Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: A systematic review.
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DOI：
10.1016/j.lanepe.2021.100253
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发表时间：
2022-01
期刊：
影响因子：
--
通讯作者：
Brown WA
中科院分区：
文献类型：
--
作者：
Amanzio M;Mitsikostas DD;Giovannelli F;Bartoli M;Cipriani GE;Brown WA
为了在临床试验中进行安全性评估，报告了接受评估的药物的不良事件(AEs)，并与安慰剂组的AEs进行了比较。对于与SARS-CoV-2疫苗临床试验相关的不良反应的性质以及这些不良反应在多大程度上可以追溯到NOCEBO效应，人们知之甚少，在这种情况下，与治疗相关的负面预期有利于它们的发生。在我们的系统综述中，我们比较了西方药品监管机构批准的SARS-CoV-2疫苗活性组和安慰剂组的AEs征集率。我们实施了一个搜索策略，通过PubMed数据库识别SARS-CoV-2疫苗的试验III研究。我们采用PRISMA声明进行研究选择和数据收集，并确定了三项试验：两项基于信使核糖核酸的试验(38403名参与者)和一项腺病毒类型的试验(6736名参与者)。相对风险显示，与安慰剂组相比，疫苗组报告的不良反应发生率更高。两组中最常见的不良反应是乏力、头痛、局部疼痛、AS注射部位反应和肌痛。特别是，在第一剂安慰剂接受者中，BNT162b2组和mRNA-1273组报告的疲劳率分别为29%和27%，而Ad26.COV2.S参与者的疲劳率为21%。据报道，在两个信使核糖核酸组中有27%的人出现头痛，在Ad26.COV2.S受体中有24%的人出现头痛。在信使核糖核酸(BNT162b2和信使核糖核酸-1273)组和Ad26.COV2.S参与者中，分别有10%和14%的人报告肌痛。在mRNA组(分别为BNT162b2和mRNA-1273)和Ad26.COV2.S受体中，局部疼痛的发生率分别为12%和17%。这些不良反应在年轻人群和第一剂接受信使核糖核酸疫苗的安慰剂接受者中更为常见。我们的结果与厌食症效应的预期理论是一致的，并提示新冠肺炎疫苗相关的不良反应可能与厌食症效应有关。Fondazione CRT-Cassa di Risparmio di Torino，IT(赠款编号66346,2019年“Gaia-Mente”)。
For safety assessment in clinical trials, adverse events (AEs) are reported for the drug under evaluation and compared with AEs in the placebo group. Little is known about the nature of the AEs associated with clinical trials of SARS-CoV-2 vaccines and the extent to which these can be traced to nocebo effects, where negative treatment-related expectations favor their occurrence. In our systematic review, we compared the rates of solicited AEs in the active and placebo groups of SARS-CoV-2 vaccines approved by the Western pharmaceutical regulatory agencies. We implemented a search strategy to identify trial-III studies of SARS-CoV-2 vaccines through the PubMed database. We adopted the PRISMA Statement to perform the study selection and the data collection and identified three trial: two mRNA-based (38403 participants) and one adenovirus type (6736 participants). Relative risks showed that the occurrence of AEs reported in the vaccine groups was higher compared with the placebo groups. The most frequently AEs in both groups were fatigue, headache, local pain, as injection site reactions, and myalgia. In particular, for first doses in placebo recipients, fatigue was reported in 29% and 27% in BNT162b2 and mRNA-1273 groups, respectively, and in 21% of Ad26.COV2.S participants. Headache was reported in 27% in both mRNA groups and in 24% of Ad26.COV2.S recipients. Myalgia was reported in 10% and 14% in mRNA groups (BNT162b2 and mRNA-1273, respectively) and in 13% of Ad26.COV2.S participants. Local pain was reported in 12% and 17% in mRNA groups (BNT162b2 and mRNA-1273, respectively), and in 17% of Ad26.COV2.S recipients. These AEs are more common in the younger population and in the first dose of placebo recipients of the mRNA vaccines. Our results are in agreement with the expectancy theory of nocebo effects and suggest that the AEs associated with COVID-19 vaccines may be related to the nocebo effect. Fondazione CRT - Cassa di Risparmio di Torino, IT (grant number 66346, “GAIA-MENTE” 2019).
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影响因子：
158.5
作者：
JEWETT, DL;FEIN, G;GREENBERG, MH
通讯作者：
GREENBERG, MH
影响因子：
3.3
作者：
LUPARELLO, T;LYONS, HA;MCFADDEN, ER
通讯作者：
MCFADDEN, ER
影响因子：
5.5
作者：
Okais, Claire;Gay, Constance;Soubeyrand, Benoit
通讯作者：
Soubeyrand, Benoit
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
影响因子：
168.9
作者：
Gupta, Ajay;Thompson, David;Sever, Peter
通讯作者：
Sever, Peter