COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says.
COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says.
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DOI：
10.3389/fimmu.2021.669010
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发表时间：
2021
影响因子：
7.3
通讯作者：
Li X
中科院分区：
文献类型：
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作者：
Chen G;Li X;Sun M;Zhou Y;Yin M;Zhao B;Li X
COVID-19 mRNA疫苗的预防性接种是此类疫苗在人类世界的首次大规模应用。截至2020年12月，美国接种了超过180万剂COVID-19疫苗，约0. 2%的人向疫苗不良事件报告系统（VAERS）提交了AE报告。本研究旨在评价免疫接种后AE（AEFI），并根据VAERS数据库中的信息分析潜在相关性。我们检索了VAERS数据库中记录的2020年12月COVID-19疫苗接种后的AEFI。在数据映射后，我们总结了报告病例的人口统计学和临床特征。使用Fisher精确检验比较具有过敏反应的AE组之间关于神经系统疾病和死亡的临床特征。2020年12月，VAERS报告了3，908起COVID-19疫苗AEFI。大多数（79.68%）发生在首次接种疫苗后。在报告的病例中，我们发现全身性疾病（48.80%）、神经系统疾病（46.39%）和胃肠道疾病（25.54%）是最常见的AEFI。有过敏反应者的过敏史发生率为64.91%，高于无过敏反应者的49.62%（OR = 1.88，P <0.017）。报告严重神经系统AEFI的受试者中有焦虑或抑郁病史的比例高于报告其他AEFI的受试者（18.37% vs.7.85%，OR = 2.64，P <0.017）。报告死亡的病例年龄明显较大（79.36 ± 10.41岁vs.42.64 ± 12.55岁，P <0.01，95%CI 29.30-44.15），更可能患有高血压（50.00% vs. 11.42%，OR = 7.76，P <0.01）和神经系统疾病（50.00% vs. 5.36%，OR = 17.65，P <0.01）。AEFI的门诊和急诊就诊率分别为11.92%和22.42%，2.53%的病例需要住院治疗。COVID-19 mRNA疫苗的AEFI通常为非重度局部或全身反应。既往过敏史是速发过敏反应的风险因素，而焦虑史可能与重度神经系统AE相关。这些疫苗接种者需要进一步的评估和监测。
The prophylactic vaccination of COVID-19 mRNA vaccines is the first large-scale application of this kind in the human world. Over 1.8 million doses of the COVID-19 vaccine had been administered in the US until December 2020, and around 0.2% submitted AE reports to the Vaccine Adverse Event Reporting System (VAERS). This study aimed to evaluate the AEs following immunization (AEFIs) and analyze the potential associations based on the information from the VAERS database. We searched the VAERS database recorded AEFIs after COVID-19 vaccines in December 2020. After data mapping, we summarized demographic and clinical features of reported cases. Fisher exact test was used to comparing the clinical characteristics among AE groups with an anaphylactic response, concerning neurological disorders and death. VAERS reported 3,908 AEFIs of COVID-19 vaccines in December 2020. Most (79.68%) were reported after the first dose of the vaccine. Among the reported cases, we found that general disorders (48.80%), nervous system disorders (46.39%), and gastrointestinal disorders (25.54%) were the most common AEFIs. The allergy history was more frequent in vaccine recipients with anaphylactic reactions than those without (64.91% vs. 49.62%, OR = 1.88, P <0.017). History of anxiety or depression was more common in subjects reporting severe neurological AEFIs than those reporting other AEFIs (18.37% vs. 7.85%, OR = 2.64, P <0.017). Cases reporting death were significantly older (79.36 ± 10.41-year-old vs. 42.64 ± 12.55-year-old, P <0.01, 95% CI 29.30–44.15) and more likely experienced hypertension (50.00% vs. 11.42%, OR = 7.76, P <0.01) and neurological disorders (50.00% vs. 5.36%, OR = 17.65, P <0.01) than other vaccine recipients. The outpatient and emergency room visit rates were 11.92 and 22.42% for AEFIs, and 2.53% of cases needed hospitalization. AEFIs of COVID-19 mRNA vaccines were generally non-severe local or systemic reactions. A prior allergy history is the risk factor for anaphylaxis, while a history of anxiety may link with severe neurological AEs. Such vaccine recipients need further evaluation and monitor.
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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
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：
10.15585/mmwr.mm7002e1
发表时间：
2021-01-15
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
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作者：
CDC COVID-19 Response Team;Food and Drug Administration
通讯作者：
Food and Drug Administration
影响因子：
7.8
作者：
Vartak A;Sucheck SJ
通讯作者：
Sucheck SJ
影响因子：
--
作者：
Nellis JC;Ishii M;Byrne PJ;Boahene KDO;Dey JK;Ishii LE
通讯作者：
Ishii LE