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Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention.
Expert Review of Vaccines ( IF 6.2 ) Pub Date : 2019-10-19 , DOI: 10.1080/14760584.2019.1676154 Pedro L Moro 1 , Penina Haber 1 , Michael M McNeil 1
Expert Review of Vaccines ( IF 6.2 ) Pub Date : 2019-10-19 , DOI: 10.1080/14760584.2019.1676154 Pedro L Moro 1 , Penina Haber 1 , Michael M McNeil 1
Affiliation
Introduction: Vaccination is one of the most successful and cost-effective public health interventions. Although vaccines undergo extensive safety and efficacy evaluations prior to licensure, vaccine safety assessment post-licensure is essential for detecting rare and longer-term adverse events (AEs) and maintaining public confidence in vaccines and recommended immunization programs. Despite the proven effect of vaccines to save lives and prevent disease and overwhelming evidence of vaccines' safety and societal benefit, like any drug, no vaccine can be considered as completely safe and completely effective. New vaccines continue to be introduced and require rapid safety assessment post-licensure through pharmacovigilance reports as well as epidemiologic studies to investigate any potential safety signals.Areas covered: We discuss selected challenges for conducting pharmacovigilance and epidemiologic studies of AEs after vaccination in the United States using the post-licensure safety surveillance infrastructure of the Centers for Disease Control and Prevention (CDC).Expert opinion: The availability of specific post-licensure surveillance systems to monitor and study AEs after vaccination, such as the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment Project, each with its unique set of strengths and limitations, provide a harmonized and supportive approach to meet several of these barriers.
中文翻译:
评估许可后疫苗安全性的挑战:疾病控制与预防中心的观察结果。
简介:疫苗接种是最成功,最具成本效益的公共卫生干预措施之一。尽管疫苗在获得许可之前经过了广泛的安全性和功效评估,但许可后的疫苗安全性评估对于检测罕见和长期不良事件(AE)以及保持公众对疫苗和推荐的免疫程序的信心至关重要。尽管已证明疫苗具有挽救生命和预防疾病的作用,并且已证明疫苗的安全性和社会效益像任何药物一样具有压倒性优势,但是没有一种疫苗可以被视为完全安全和完全有效。新疫苗将继续被引入,并需要通过药物警戒性报告以及流行病学研究对许可后的安全性进行快速评估,以调查任何潜在的安全性信号。
更新日期:2019-11-01
中文翻译:
评估许可后疫苗安全性的挑战:疾病控制与预防中心的观察结果。
简介:疫苗接种是最成功,最具成本效益的公共卫生干预措施之一。尽管疫苗在获得许可之前经过了广泛的安全性和功效评估,但许可后的疫苗安全性评估对于检测罕见和长期不良事件(AE)以及保持公众对疫苗和推荐的免疫程序的信心至关重要。尽管已证明疫苗具有挽救生命和预防疾病的作用,并且已证明疫苗的安全性和社会效益像任何药物一样具有压倒性优势,但是没有一种疫苗可以被视为完全安全和完全有效。新疫苗将继续被引入,并需要通过药物警戒性报告以及流行病学研究对许可后的安全性进行快速评估,以调查任何潜在的安全性信号。