National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E05, Atlanta, GA 30333, USA.
Curr Opin Pediatr. 2010 Feb;22(1):88-93. doi: 10.1097/MOP.0b013e3283350425.
An understanding of vaccine safety is important for all immunization providers, who have responsibilities to identify, report, and prevent adverse events.
New analytic methods can provide more rapid information on adverse events compared with traditional observational studies. Some adverse events following vaccination are preventable. Syncope is increasingly recognized postvaccination and may be associated with severe injury or death. Both human and system factors should be addressed to prevent vaccine administration errors. Ongoing basic science and clinical research is critical to improved understanding of vaccine safety. A recent study suggests that many cases of encephalopathy following whole-cell pertussis vaccine were due to severe myoclonic epilepsy of infancy, a severe seizure disorder associated with mutations of the sodium channel gene SCN1A.
Vaccine safety requires prelicensure evaluation, postlicensure surveillance and investigation, addressing preventable adverse events, reconsideration of vaccine policy as understanding of risks and benefits changes, and ongoing research to better understand the response to vaccination and the pathogenesis of adverse events.
了解疫苗安全性对于所有免疫接种提供者都很重要，他们有责任识别、报告和预防不良事件。
与传统的观察性研究相比，新的分析方法可以提供更快速的不良事件信息。一些疫苗接种后的不良事件是可以预防的。接种疫苗后晕厥越来越常见，可能与严重伤害或死亡有关。应解决人为和系统因素，以预防疫苗接种错误。正在进行的基础科学和临床研究对于提高对疫苗安全性的认识至关重要。最近的一项研究表明，全细胞百日咳疫苗接种后许多脑病病例是由于婴儿严重肌阵挛性癫痫引起的，这是一种与钠通道基因 SCN1A 突变相关的严重癫痫发作疾病。
疫苗安全性需要在许可前进行评估、许可后进行监测和调查，以解决可预防的不良事件，随着对风险和收益的理解的变化，重新考虑疫苗政策，并进行持续研究以更好地了解接种疫苗后的反应和不良事件的发病机制。
