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保证SARS-CoV-2疫苗的安全性
Maintaining Safety with SARS-CoV-2 Vaccines


Mariana C. Castells ... 呼吸系统疾病 • 2021.02.18
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迄今预防SARS-CoV-2感染的mRNA疫苗研发工作可谓成功,而且在仍开展的3期临床试验期间未发生严重问题1。疫苗组出现疼痛、发红、肿胀等轻微局部副作用的比例高于安慰剂组。发热、疲乏、头痛、肌肉和关节疼痛等全身症状的发生率也是疫苗组略高于安慰剂组,而且大多数症状出现在接种疫苗后24~48小时1。辉瑞-BioNTech联合开发及莫德纳(Moderna)开发的mRNA疫苗均在1~3期临床试验中排除了对疫苗任一成分有过敏史的潜在参与者。在辉瑞-BioNTech的疫苗研究还排除了对任何疫苗有严重过敏史的参与者(完整排除标准请参见这两项试验的研究方案,研究方案与本文全文可在NEJM.org获取)1,2。在这两项试验中,安慰剂(正常生理盐水)和疫苗组中过敏性不良事件的发生率相同1





作者信息

Mariana C. Castells, M.D., Ph.D., and Elizabeth J. Phillips, M.D.
From Brigham and Women’s Hospital, Boston (M.C.C.); and the Department of Medicine, Vanderbilt University Medical Center, Nashville (E.J.P.).

 

参考文献

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