中欧预防控制口蹄疫2011年培训4.ppt

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 program）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?）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 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 quality 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 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 production,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 trials,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 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 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 Production and Storage in India）2.不丹疫苗的不丹疫苗的审批注册（批注册（Vaccine Registration in Bhutan）3.不丹的疫苗运不丹的疫苗运输（Transport of vaccine to Bhutan）4.国家疫苗中心疫苗的接受、国家疫苗中心疫苗的接受、储备和派送和派送（Receival,storage and dispatch at National Vaccine Centre）5.从国家疫苗中心到地方的派送（从国家疫苗中心到地方的派送（Transport from NCAH to Districts）6.地方疫苗地方疫苗储备（Storage at Districts）7.乡镇运运输（Transport to villages）8.乡镇储备（Storage at villages)9.田田间疫苗的疫苗的实施和管理施和管理(Handling and administration of vaccines in the field)12表表1 在不丹影响疫苗在不丹影响疫苗质量和效量和效力力的途径和因素的途径和因素 Table 1-Pathway and factors affecting vaccine quality and efficacy in Bhutan途径（途径（Pathway）影响影响FMD疫苗效价的因素（疫苗效价的因素（Factors affecting the efficacy of vaccines for FMD）在印度疫苗的生在印度疫苗的生产和和储备（Vaccine Production and Storage in India）符合符合GMP和和OIE标标准（准（Compliance with GMP and OIE Standards）质质量和匹配量和匹配评评价的依据（价的依据（Evidence of evaluation of quality and matching）生生产过产过程中和生程中和生产产后疫苗后疫苗质质量的量的评评价依据价依据（Evidence of evaluation of vaccine quality during and after production）存存储储条件条件Storage conditions(Temperature 2-8 C)）疫苗来源疫苗来源Source of vaccines(Direct or indirect supply)13Table 1-Pathway and factors affecting vaccine quality and efficacy during production,registration,transport,storage,distribution and use of FMD vaccines in Bhutan从疫苗供应商获取评价资料Obtain Evaluation Data from Vaccine Supplier 14疫苗注册Vaccination Registration不丹的疫苗注册不丹的疫苗注册Vaccine Registration in Bhutan符合符合GMP和和OIE要求的最低要求的最低质质量、安全、效价量、安全、效价和和纯纯度度标标准（准（Compliance with minimum standards(GMP and OIE)for quality,safety,potency and purity）确保疫苗株匹配田确保疫苗株匹配田间间流行株（流行株（Ensure vaccine strains have a reasonable match with field strains）疫苗疫苗类类型（油苗或水苗）符合用途（型（油苗或水苗）符合用途（Type of vaccine(oil or aqueous)is fit for purpose）需要符合生物安全需要符合生物安全标标准和杜准和杜绝绝与其它病原微生与其它病原微生物物污污染（染（Require compliance with standards for biosecurity and to prevent contamination with other pathogens）决策是基于公司提供的决策是基于公司提供的证证据和其它来源据和其它来源 Decisions to be based on evidence provided by company and other sources）15疫苗运输到不丹Transport of vaccine to Bhutan疫苗运输到不丹Transport of vaccine to Bhutan运输方法（空运或陆运）Method of transport(air or road)运输条件（集装箱类型、温度控制和定时）Conditions for transport(type of container,temperature control and timing)直接或间接运输（卸载风险）Direct or indirect transport(risk of offloading)16标准疫苗使用中的效力评价Evaluate Vaccine Efficacy using Vaccines received核对实验（Controlled experiment）使用非免疫动物（Using unvaccinated animals）免疫21-28天后血清学检测（Serological testing after 21-28 days）17国家疫苗中心疫苗的接受、存储和派发Receival,storage and dispatch at National Vaccine Centre国家疫苗中心疫苗的接受、国家疫苗中心疫苗的接受、存存储和派和派发（Receival,storage and dispatch at National Vaccine Centre）从机从机场场运运输输条件条件(冷藏冷藏车车、集装箱和控温、集装箱和控温)Conditions for transport from airport(refrigerated vehicles,containers and temperature control)存存储储条件条件Storage conditions(temperature maintained between 2-8 C)记录记录（Record keeping）疫苗效力疫苗效力评评价（价（Evaluation of efficacy and potency of vaccines）18往地区中心的运输和存储Transport to and storage at District Centres从国家疫苗中心到从国家疫苗中心到Dzongkhags和和RLDCs的运的运输（Transport from NCAH to Dzongkhags and RLDCs）运运输输条件（条件（车辆车辆和控温）和控温）Conditions of transport(vehicles and temperature control)延延误误的的风险风险或或时间时间偏差（偏差（Risk of delays or deviation from schedule）在在Dzongkhags/RLDCs 的的存存储（Storage at Dzongkhags/RLDCs）存存储储条件（温度和条件（温度和记录记录）Storage conditions(temperature and record keeping)19运输至地方/村庄Transport to Geog/village level运输至地方/村庄Transport to Geog/village level运输条件（Conditions of transport）Distance and timing including walking to remote villages地方/村庄的存储Storage at Geog/villages存储条件（温度、电力供应和所有设备）Storage conditions(temperature,power availability and equipment used)20田间疫苗的实施和管理Handling and administration of vaccines in the field田间疫苗的实施和管理（Handling and administration of vaccines in the field）条件（温度和设备）Conditions(temperature,equipment)有效地管理方法（Effective administration method）家畜业主的协助（Cooperation by livestock owners）免疫接种动物的比例（Proportion of animals vaccinated）工作人员的培训（Training of field staff）21田间免疫后的评价Evaluation after Field Use田间运用后试点村庄/动物确定（Identify and sample villages/animals after routine application in the field）免疫后21-28天血清学检测（Test 21-28 days after vaccination）LPBE和滴度检测（Tests LPBE and titre）覆盖和保护水平（Coverage and level of protection）22在中国疫苗使用的评价Evaluation of Vaccine Usage in China意见Comment讨论Discussion23