欧盟预防用疫苗药物警戒特殊要求及启示

目的:通过对欧盟预防用疫苗药物警戒特殊要求的介绍,为完善和发展我国疫苗不良反应报告和监测体系提供借鉴和参考。方法:对欧盟药品管理局官方网站有关药物警戒以及预防用疫苗特殊要求的文献资料进行分析研究。结果与结论:欧盟预防用疫苗药物警戒工作在风险管理系统、定期安全性更新报告、上市后安全性研究、信号管理、批次召回或封存等方面值得借鉴和参考,对于我国开展疫苗药物警戒的重要意义、风险管理、病例定义标准化以及安全性沟通等方面提出了思考和启示。     

布赖顿协作组:满足对标准化AEFI病例定义的需要

临床试验和监测系统资料的可比性对进一步促进免疫接种安全性的发展甚为必要.资料可比性要求有标准化免疫接种后不良反应(AEFI)病例定义和病例确定、记录和资料报告准则.由发达国家和发展中国家的专家志愿者组成的国际协作工作组,进行系统的文献复习以提出50～100个AEFI定义.由免疫接种安全性相关组织组成的咨询组,在评论期后最终确定病例定义,并通过万维网(www)和其他方式发布,供全球免费使用.文献回顾结果表明,资料的收集和报告差异很大,故应制订供临床试验和监测系统使用的标准化病例定义和准则.由于安全性测定方法的不同导致科学信息大量丢失.为此,建立了必要的国际网络,目前该网络由300名来自病人保健、公共卫生、科学、制药、管理和专业机构人员组成,以制订和评价标准化AEFI病例定义和准则.评估研究、全球实施、正在进行的定义制订和日益扩大的网络对协作成功至关重要.     

2011-2012年华泾镇预防接种不良反应监测分析

目的：了解华泾镇2011—2012年预防接种后不良反应发生情况。方法：根据WHO对AEFI的定义与分类,收集华泾镇2011-2012年AEFI监测和接种率监测数据,进行描述统计。结果：共报告AEFI65例,发生率为141．70／10万。一般反应57例,占AEFI总病例数的87．69％;异常反应8例,占12．31％。19种疫苗中有13种出现不良反应,其中百白破疫苗的报告发生率最高,为493．33／10万,其次为肺炎疫苗,为369．78／10万。结论：2011-2012年华泾镇AEFI监测系统运转良好,今后需进一步探讨AEFI主动监测模式,提高疫苗安全性监测的敏感性。     

黄热病疫苗的安全性

17D黄热病疫苗在数百万接种者中具有极好的安全性记录 ,但近年来在美国、澳大利亚等地相继报道了多起与黄热病疫苗相关的嗜内脏性和神经毒力的不良反应病例 ,为此 ,美国疾病预防和控制中心 (CDC)等机构相继提议 ,应对该疫苗加强安全性监测和修订生产用毒株的安全性检测指标。     

全球疫苗安全性展望

"免疫安全性"仍是一大问题.1999年世界卫生组织(WHO)疫苗和生物制品部启动了免疫安全优先计划,以建立确保国家免疫计划内所有免疫接种安全性的综合系统.本文阐述了树立疫苗安全性形象的问题和关键因素以及售后监测的重要性和局限性;介绍了WHO的一些支持行动,包括设立全球疫苗安全性咨询委员会,以提供对疫苗安全问题的科学评估.     

布赖顿协作组：满足对标准化AEFI病例定义的需要

临床试验和监测系统资料的可比性对进一步促进免疫接种安全性的发展甚为必要。资料可比性要求有标准化免疫接种后不良反应(AEFI)病例定义和病例确定、记录和资料报告准则。由发达国家和发展中国家的专家志愿者组成的国际协作工作组，进行系统的文献复习以提出50～100个AEFI定义。由免疫接种安全性相关组织组成的咨询组，在评论期后最终确定病例定义，并通过万维网(www)和其他方式发布，供全球免费使用。文献回顾结果表明，资料的收集和报告差异很大，故应制订供临床试验和监测系统使用的标准化病例定义和准则。由于安全性测定方法的不同导致科学信息大量丢失。为此，建立了必要的国际网络，目前该网络由300名来自病人保健、公共卫生、科学、制药、管理和专业机构人员组成，以制订和评价标准化AEFI病例定义和准则。评估研究、全球实施、正在进行的定义制订和日益扩大的网络对协作成功至关重要。     

抚顺市2011年疑似预防接种异常反应监测分析

目的 分析抚顺市2011年疑似预防接种异常反应(AEFI)的发生特征,评价疫苗的安全性,为建立预防接种安全监测体系提供依据.方法 采用描述性方法对病例资料进行统计分析.结果 2011年全市共报告AEFI病例127例,其中一般反应124例,占97.64％;异常反应2例,占1.57％;偶合症1例,占0.79％.报告发生反应的疫苗17种,AEFI发生率为13.33/10万,以无细胞百白破报告发生率最高98.08/10万.结论 病例报告有待于提高,定期开展专项培训、AEFI监测督导,对AEFI监测进展和存在问题进行分析,并及时向下级单位反馈.提高监测系统敏感性,增强公众对预防接种的信心,保证预防接种的安全实施.     

黄热病疫苗的安全性

17D黄热病疫苗在数百万接种者中具有极好的安全性记录，但近年来在美国、澳大利亚等地相继报道了多起与黄热病疫苗相关的嗜内脏性和神经毒力的不良反应病例，为此，美国疾病预防和控制中心(CDC)等机构相继提议，应对该疫苗加强安全性监测和修订生产用毒株的安全性检测指标。     

疫苗产品全生命周期外源因子安全性风险评估及质量控制探讨

目的 探讨对疫苗生产过程及上市后产品进行外源因子安全性风险评估的方法及其质量控制的要求与原则.方法 根据生物制品病毒安全性相关法规及指导原则,参考近年来监测到的外源因子对疫苗产品带来的安全性风险,分析疫苗生产过程中外源因子风险及上市后疫苗产品病毒安全性追溯和风险防控措施.结果 对疫苗产品及其全生命周期外源因子风险性评价...     

我国疫苗风险管理模式探讨

药品风险管理是围绕药品安全性问题开展的,通过上市前研究或上市后不良反应监测,完成药品风险评估、风险控制、风险审核和风险沟通的系统过程.疫苗作为一种特殊的药品,其风险管理尤为重要.本文分析了我国疫苗不良反应监测的现状及存在的问题,并参考国际先进经验,对我国疫苗风险管理模式进行了探讨.     

Improving global monitoring of vaccine safety: a survey of national centres participating in the WHO Programme for International Drug Monitoring.

BACKGROUND: The WHO Programme for International Drug Monitoring (PIDM) was established in 1968 following the thalidomide disaster. The PIDM has had considerable success in analyzing drug-related adverse event reports, but more limited progress has been made in analyzing vaccine-related reports. In June 2005, the Global Advisory Committee on Vaccine Safety, acknowledging these limitations, called for a global consultation to address the need for improved monitoring and analysis of vaccine-related adverse event reports on an international level. OBJECTIVE: In preparation for this consultation and as part of a larger study designed to evaluate the PIDM, a survey of the National Pharmacovigilance Centres of all 76 countries participating in the PIDM at the time the survey was conducted. RESULTS: Thirty-six countries (47%) responded. Of the 36 responding countries, 16 (44%) reported having a separate surveillance system for adverse events following immunizations (AEFIs) and 30 (83%) reported forwarding AEFI reports to the PIDM. Seven of the 36 countries (19%) indicated that one or more population subgroups are systematically excluded from their country's AEFI surveillance system. Five of the seven countries exclude reports concerning recipients of travellers' vaccines; three exclude recipients of vaccines administered by private physicians outside the national immunization programme and supply scheme; and five exclude reports from the military sector. Only half of the respondents knew of the Brighton Collaboration, a major international initiative aimed at the standardization of AEFI definitions. CONCLUSION: The survey identified critical elements that should be addressed quickly to improve global vaccine safety monitoring. Communication between national adverse drug reaction and AEFI surveillance authorities, ability to pay for advancing technology in developing countries, and proper use of services and terminologies are issues of concern.     

Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulin

A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants specific educational efforts to prevent further repetitions. It also has more general implications for medical product safety surveillance. First, this problem's original detection depended on the Pregnancy Registry's open-ended collection of information about pregnancy exposures. It could have escaped recognition through surveillance limited to pre specified potential risks. This need for unrestricted reporting and human vigilance to sift through case stories has particular relevance for efforts to re-think methods to monitor gestational drug exposures. In addition, the problem's persistence despite initial publicity suggests that diligent surveillance may require continued follow-up of identified safety issues. Periodic reassessments of selected preventable problems might strengthen efforts to minimize product risks.     

Hypotonic-hyporesponsive episodes following pertussis vaccination: a cause for concern?

Vaccine safety has become a major community concern and of particular importance for parents, vaccine recipients and vaccine providers. A hypotonic-hyporesponsive episode (HHE) is a sudden and unexpected episode of loss of tone, unresponsiveness and colour change which uncommonly affects infants and children after vaccination. Although any vaccine may be associated with this adverse event, HHE usually follows administration of a pertussis containing vaccine. There has been renewed interest in this adverse event in the light of community concerns regarding vaccine safety. The focus of this interest has been to formulate an acceptable case definition, to document possible risk factors and to better define the outcome of HHE. In addition, studies have documented the outcome of revaccination of children who have had an HHE. Although much remains to be learnt about HHE it would appear that there are no long-term sequelae and that children who have had an HHE can be revaccinated. Parents should be provided with the available information such that they can make an assessment of the risks and benefits of pertussis vaccination. The benefits of pertussis vaccination still outweigh the risk and universal childhood pertussis vaccination should continue to be advocated.     

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.     

Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention

ABSTRACT

Introduction: Annual influenza vaccine safety monitoring is an important component of the influenza vaccination program in the United States to ensure that vaccines are safe, which is important for maintaining public trust in the national vaccination program. This is specially the case for influenza vaccines since the antigen composition of the viruses of which the vaccine is made often changes from one season to the next, based on the circulating strain of influenza virus.

Areas covered: This review describes the two surveillance systems used by the Centers for Disease Control and Prevention (CDC) to monitor the safety of influenza vaccines: 1) the Vaccine Adverse Event Reporting System (VAERS); and 2) the Vaccine Safety datalink (VSD).

Expert opinion: VAERS and VSD are used routinely to monitor the safety of influenza vaccines in the United States, and over the years they have demonstrated their value in monitoring vaccine safety since their implementation in 1990. Both systems, although different, complemented each other well to study febrile seizures in young children following influenza vaccination during the 2010–2011 influenza season. Other examples of potential safety concerns after influenza vaccines are also presented and discussed.     

Restoring confidence in vaccines by explaining vaccine safety monitoring: is a targeted approach needed?

Public trust in childhood vaccines is crucial to achieving adequate immunisation coverage to ensure population-level immunity. However, in the UK, immunisation uptake has been adversely affected by vaccine safety scares, such as those surrounding whooping cough and measles, mumps and rubella (MMR). It is our belief that greater public awareness of safety surveillance schemes may play a key role in improving trust in vaccine safety. Many parents of vaccination-age children are unaware of the procedures in place for postmarketing surveillance of vaccines. Thus, we propose specific steps for generating such awareness, such as assisting parents to report suspected adverse reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card scheme, providing information about adverse reaction reporting with vaccination information packs, and displaying posters and leaflets to convey the message that patient concerns and experiences are taken seriously by the MHRA and to generate further awareness about the scheme. In addition, healthcare staff should be encouraged to report suspected adverse reactions relating to vaccine products. Unresolved issues about the scientific usefulness of data reported by parents and the potential for these steps to increase parental concern and expectations require further investigation.     

安徽省2009年麻疹疫苗强化免疫疑似预防接种异常反应监测分析

目的了解安徽省2009年麻疹疫苗强化免疫活动（supplementaryimmunizationactivity,SIA）中,疑似预防接种异常反应（adverseeventsfollowingimmunization,AEFI）的发生特征,探讨麻疹疫苗的安全性。方法采用描述性流行病学方法,对AEFI监测系统中的相关数据进行统计分析。结果安徽省2009年麻疹疫苗SIA共报告AEFI41例,AEFI报告发生率3．86／100万剂。78．05％AEFI发生于接种后1d以内,82．93％AEFI发生于接种第1剂麻疹疫苗后。临床损害以发热、过敏性皮疹等为主。结论安徽省2009年SIA的麻疹疫苗安全性良好。接种麻疹疫苗后≤1d是AEFI的监测重点。     

Monitoring the safety of vaccines: assessing the risks.

The safety of vaccines, particularly the most widely used vaccines to which most children are exposed as infants and toddlers, has always been an extremely high priority for vaccine manufacturers and government agencies. Products intended for healthy people must be held to a high standard of safety assurance. In addition to the intense safety assessments conducted prior to licensure, post-marketing surveillance programmes are essential to identify and study possible risks that occur too rarely to have been identified in pre-licensure studies or that occur in populations not studied in pre-licensure studies. Studying rare risks of vaccines is more complex than for therapeutic products because the exposure is virtually universal for many vaccines, ensuring occurrence simply by chance of many adverse outcomes in temporal association with vaccination. In the US the Vaccine Safety Datalink (VSD), a consortium of managed care organisations, has been established to study more rigourously possible vaccine-associated risks. These risks may be identified through reports to the Vaccine Adverse Event Reporting System (VAERS), the nationwide passive surveillance programme, as well as other sources. The combination of passive surveillance and more structured case-control or cohort studies possible in the VSD has helped to both identify new vaccine risks and to provide reassuring evidence of lack of risk in other situations where concerns have been raised.