Tozzi Alberto E
Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161 Rome, Italy.
Vaccine. 2004 May 7;22(15-16):2091-5. doi: 10.1016/j.vaccine.2004.01.013.
Surveillance of adverse events in the field represents an essential part of vaccination strategies. Safety studies conducted before vaccine licensure have often not enough power to detect rare or long-term adverse events. Furthermore, adverse events may be caused by incorrect procedures of storage or administration. Conducting surveillance of adverse events in the field is necessary for detecting unexpected increases in incidence of adverse events, for continuing education of health personnel involved in vaccine programs, for providing appropriate information to the public, and for supporting interventions to prevent further adverse events. Signals generated by surveillance systems may stimulate to conduct formal studies to assess causality.
对现场不良事件的监测是疫苗接种策略的重要组成部分。疫苗获得许可前进行的安全性研究往往没有足够的能力检测罕见或长期不良事件。此外,不良事件可能由不正确的储存或接种程序引起。对现场不良事件进行监测对于发现不良事件发生率的意外增加、对参与疫苗项目的卫生人员进行继续教育、向公众提供适当信息以及支持预防进一步不良事件的干预措施而言是必要的。监测系统产生的信号可能促使开展正式研究以评估因果关系。