中欧预防控制口蹄疫2011年培训4.ppt
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1、口蹄疫疫苗的使用和口蹄疫疫苗的使用和评价价Uses and Evaluation of Vaccines for FMD 口蹄疫防控培口蹄疫防控培训Training to improve control and prevention of Foot and Mouth Disease(FMD)Lanzhou,China 8-12 August 2011Directorate-General for Health and Consumers of the European Commission(DG SANCO)1报告内容报告内容(Scope of Presentation)口蹄疫疫苗使用(口蹄
2、疫疫苗使用(Using vaccines for FMD)在不丹疫苗在不丹疫苗评估范例(估范例(Example of Evaluation of Vaccines in Bhutan)讨论中国疫苗的使用(中国疫苗的使用(Discussion on vaccine usage in China)2口蹄疫疫苗的使用(Uses of FMD Vaccines)目的?(目的?(What is the purpose?)设计免疫程序需要的流行病学信息(设计免疫程序需要的流行病学信息(Need epidemiological information to design vaccination progra
3、m)靶标高风险区(靶标高风险区(Targeting to high risk areas)措施选择,如监测措施选择,如监测/限制动物移动(限制动物移动(Is there an alternative?eg Surveillance/movement control)疫苗选择(疫苗选择(Choice of vaccine?)质量、生物安全和抗原匹配(质量、生物安全和抗原匹配(Quality,biosecurity and matching)疫苗覆盖和频率水平(疫苗覆盖和频率水平(Level of coverage and frequency停用疫苗时间(停用疫苗时间(When to stop?)
4、3免疫目的(免疫目的(Purposes for Vaccination)预防和控制(Prevention and control)区域化(Zoning)贸易(Trade)疫苗和监测(Vaccines and surveillance)OIE法典(OIE codes)4影响口蹄疫疫苗质量的因素Factors affecting the quality of FMD vaccines生产口蹄疫疫苗是昂贵和复杂的(FMD vaccines are expensive and complex to produce)出厂到使用之间的容忍度是很窄的(Narrow margins of tolerance
5、for inappropriate storage and use.)容易形成毒株和亚毒株的特异性(Tend to be strain or sub-strain specific and)短的免疫期(Short duration of immunity)需要关注质量、安全性、保护效力、纯度和使用条件(Need to focus on quality,safety,potency,purity,and the conditions of use)有限效力的常见的暗示(Frequent suggestions of limited efficacy)5需要完成的质量、安全性、保护效力、纯度相关最
6、低标准(Need to comply with minimum standards for quality,safety,potency and purity.)依据GMP和OIE标准的疫苗生产(Produced according to good management practice(GMP)and the OIE Standards)可接受的抗原匹配性(Acceptable matching)6维持田间疫苗质量(Maintaining the Quality of Vaccine under Field Conditions)在许多国家保持疫苗质量需要在严刻的条件(Maintain qu
7、ality only to Provincial/District Level in many countries)许多限制:温控、不完全免疫、管理差、缺乏培训等(Limitations due to temperature control,incomplete vaccination,poor administration,lack of training etc.)冷冻影响(Effects of freezing)高温影响(Effects of high temperature)佐剂差别(Difference between adjuvants)好疫苗或许需要短期温度变化的耐温性(For
8、good vaccines may be some tolerance for short term variation in temperature)慢慢冷冻和接近体温条件将使疫苗无效(Slow freezing and at temperatures near body temperature,vaccine will become ineffective)7在疫苗生产、运送和使用期间影响疫苗质量、安全性和效力的分析范例Example of an analysis of the factors affecting vaccine quality and efficacy during pr
9、oduction,distribution and use of FMD vaccines 在田间经常遇见的疫苗效力问题Frequently questions about the efficacy of vaccine in the field8评估疫苗项目Project to Evaluate FMD Vaccines9目标:在不丹评估口蹄疫免疫的项目(Aim:Project to evaluate FMD vaccination in Bhutan)在生产、攻毒和血清学评价(Evaluation of FMD vaccines during manufacture,challenge t
10、rials,serological evaluation(OIE))疫苗资料,包括质量数据、疫苗毒株、交叉匹配结果(Source of Vaccine(including quality data,vaccine strain,cross matching results)储存、转运和免疫操作(Storage,transport and handling of vaccines at all levels)方案和培训(Protocols and training)评估疫苗效力项目的例子Example of a project to evaluate vaccine efficacy例1-路径分
11、析-转运、储存和使用(Component 1-Analysis of the pathway for transport,storage and use of FMD vaccine)例2-评价使用国家疫苗中心疫苗的保护和交叉保护水平(Component 2-Evaluation of the level of protection and coverage of FMD vaccines received at the National Vaccine Centre.)例3-评价三个田间区域常规疫苗的保护和交叉保护水平(Component 3-Evaluation of the level
12、of protection and coverage using FMD vaccines following routine vaccination at three field locations)10不丹事例分析Example in Bhutan分析整个路径-生产、供应、储存、分派和田间使用(Analysis of the whole pathway of production,supply,storage,distribution and use of FMD vaccines in the field.)上述每一步能够影响疫苗质量和效力的因素(The factors that can
13、 affect vaccine quality and efficacy at each stage described.)储存温度的使用(Use of temperature loggers)鉴定的最相关和集中核心要点(Identify points of greatest concern and for targeted intervention)11疫苗生产、储备、运输和使用过程中的要点Critical points in the Vaccine Production,Storage,Distribution and Use1.在印度疫苗的生在印度疫苗的生产和和储备(Vaccine Pr
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