成都市2018年预防接种门诊疫苗储存冷链设备容积评价

目的评价成都市预防接种门诊疫苗储存冷链设备容积。方法对成都市2018年所有预防接种门诊的疫苗冷链设备开展调查,计算门诊疫苗储存的冷链容积需要量(VCN)和2个月疫苗储存量的冷链容积匹配度(MVC)。结果成都市2018年436家预防接种门诊的总VCN为3434.22m^3,平均VCN为7.88m^3/门诊/年。疫苗储存冷藏容积共990443L,平均2272L/门诊。全市预防接种门诊平均MVC(2个月)为2.02,其中MVC>1.20、1.01-1.20、≤1.00的门诊分别占55.74%、8.03%、36.23%;门诊平均疫苗可储备天数为87d,其中≤30d、31-60d、>120d的门诊分别占16.28%、27.98%、23.39%。结论成都市2018年预防接种门诊疫苗储存冷链设备容积分布不均衡,容积不足和过剩的门诊比例较大。     

新冠疫苗规模接种下疫苗冷链运输工作的思考

目的 在保证常规疫苗日常储运的同时,大规模的新冠疫苗配送给疫苗冷链运输带来了重大的挑战及机遇.本文就疫苗生产企业配送的运营模式和疾病预防控制(疾控)机构冷链设备、管理人员等方面分析当前国内疫苗冷链运输工作状况,从企业采用自营或与第三方合作、疾控机构对设备进行升级优化、人才培养及整合现有运力资源等方面提出解决思路,希望促...     

云南省部分接种点麻疹疫苗效力及冷链运转效果评价

采用跟踪和特殊目的的监测方式和抽样方法,首次对云南省不同气候、不同地区、不同层次(省、地、县、乡、村接种点)进行麻疹疫苗效价测定.结果显示:81个麻疹疫苗样品中,76.54%达到出厂合格滴度(≥3.5 logTCID50/1 ml),各层次疫苗滴度均值均在3.5以上,无显著性差异(P＞0.05);1个地区地级、乡级、村接种点达到出厂合格滴度的仅为0和50%,疫苗滴度均值均在3.5以下,有显著性差异(P＜0.05).提示:调查地区冷链运转基本正常,但个别地区冷链和疫苗管理工作需进一步改进.     

免疫规划制品数据库在冷链容积需要量测算中的应用

目的探索利用免疫规划制品数据库（Immunization Products Database,IPD）测算免疫规划冷链容积需要量的方法。方法利用IPD中每种产品的每剂次体积乘以该产品接种剂次数,并考虑库存预留和空间预留因素,计算出实际需要的冷链容积。结果根据冷链容积需要量公式,计算出上海市某县级疾病预防控制中心（CDC）某年的冷链容积需要量为23．6m^3,该县级CDC的冷库容积能满足需求。结论通过IPD的产品每剂次体积和基于IPD的产品编码收集的接种剂次数,可以对免疫规划冷链容积需要量进行精确测算,为配置冷链提供依据。     

江苏省疫苗冷链设备和监测系统建设现状与评价

目的 评价江苏省疫苗冷链设备的配置和监测系统运用情况.方法 自制调查表进行网络直报,并结合江苏省预防接种综合服务管理信息系统中的资料,对全省配置的冷链设备和监测系统建设现状进行分析.结果 调查全省125个疾控机构和2232个接种门诊,共建有低温疫苗冷库8座、普通冷库250座,苏南、苏中、苏北冷库拥有率分别为3.77、1.12、0.94座/家;共有疫苗冷藏车150辆,苏南、苏中、苏北分别为1.52、0.96、1.01辆/家;配备疫苗冷藏车150辆、低温冰箱1710台、普通冰箱6694台,冷链设备与监测系统对接率100.00％,实现疫苗存储运输过程中每个环节每个过程的溯源.发现存在冷链设备配置不足、疫苗运输过程不完备、基层人员培训不足和缺少应急预案和演练等问题.结论 江苏省疫苗冷链设备和监测系统基本保障了疫苗的质量安全,但仍存在不足,需在硬件投入、运输标准化、基层人员培训和应急演练等方面进行改进,提高全省免疫规划整体水平.     

呼和浩特市2008年冷链设备容积调查

目的了解目前呼和浩特市、旗县区、乡镇各级疾病预防控制机构冷链设备容积现状,给今后装备冷链设备提供科学依据。方法随机抽查一个县的一个乡,调查其实际冷链设备情况,同时根据报表资料及领苗情况记录,查看运转一次的疫苗数量,从而进一步计算各级疾控机构冷链设备所需的容积。结果各旗县区冷链设备的容积普遍不能满足工作需要,仅仅武川县由于接种二类疫苗少,尚能够满足需要。结论基层冷链设备容积普遍不足,需要进一步地完善。     

上海市青浦区社区预防接种门诊冷链容积评估

目的对上海市青浦区社区预防接种门诊冷链容积进行评估,为冷链合理配置提供参考。方法通过上海市疾病预防控制中心开发的免疫规划制品数据库(immunization products database,IPD)、青浦区2013年接种率监测数据库和社区预防接种门诊冷链设备数据库获得基础数据,计算各接种门诊冷链实际配备与需要量比值。结果青浦区各社区预防接种门诊冷链容积需要量以徐泾接种门诊最大(2 246.26 L),金泽分门诊最小(135.8 L)。实际容积配备量最大的为盈浦接种门诊(3 936 L)、最小为西岑接种门诊(1 102L)。配备容积相对充足的金泽(11.12)、商榻(7.80)、西岑(6.56),相对紧张的是徐泾(1.15)、白鹤(1.26)、赵巷(1.57)。青浦区各社区接种门诊2013年共使用47种疫苗,其中一类疫苗14种,二类疫苗33种;使用的14个一类疫苗产品中仅有3个产品每剂次体积100 cm3,而33个二类疫苗产品中有17个产品每剂次体积100 cm3;2013年青浦区一类疫苗、二类疫苗接种39余万剂次,一类疫苗和二类疫苗接种剂次比为1.54:1。结论青浦区社区预防接种门诊冷链容积总体容量是充足的,但在各社区接种门诊间应进行相应的优化配置,满足合理需要同时,杜绝资源浪费。     

吉林省1989～1996年口服脊髓灰质炎疫苗、麻疹疫苗效力及冷链运转效果评价

对吉林省１９８９～１９９６年口服脊髓灰质炎（脊灰）疫苗（ＯＰＶ）和麻疹疫苗（ＭＶ）经运输、贮存后的效价，以及冷链运转效果进行了评价。检测结果表明，１９９０～１９９６年共检测省卫生防疫站冷库ＯＰＶ３５批，达到出厂合格滴度（５７０ｌｏｇＣＣＩＤ５０／人份）的２５批，占７１４３％；１９８９～１９９６年，检测省卫生防疫站冷库ＭＶ４９批，都达到合格滴度（３５ｌｏｇＣＣＩＤ５０／１ｍｌ）。从各级采样点检测的结果，与省卫生防疫站冷库相比较，无论是ＯＰＶ还是ＭＶ，差异均无显著性（Ｐ＞００５）。由链头（省卫生防疫站冷库）至链尾（接种点），两种疫苗均保持较高的效价，提示我省自１９８９年以来冷链运转良好，而且ＭＶ稳定性较好，优于ＯＰＶ。由于冷链的正常运转，使我省计划免疫工作质量有很大提高。ＯＰＶ、ＭＶ的接种率、免疫成功率均达９６％以上，发病率明显下降。     

疫苗冷链网络实时监测系统应用1年后效果评价

目的分析和评价北京市顺义区疫苗冷链网络实时监测系统运行状况,以提高监督管理水平。方法收集物联网技术引入疫苗冷链管理后的数据采用Microsoft Excel 2010软件,对资料进行统计分析。结果共监测33家接种单位136台疫苗冷链设备,监测到报警53 779次;94.33%的告警时间持续在30 min以内,告警时间持续2 h以上的仅占1.11%;98%以上的告警温度小于1℃;54.71%的告警发生在非正常上班时间;共发送告警和告警恢复短信19 219条;药剂科冰箱报警率高于其他冰箱。结论该系统对全区疫苗冷链设备做到了实时监测,及时发现了告警并发送短信,特别是对非上班时间的监测,有效地减少了疫苗冷链事故的发生,是疫苗安全的有效保障之一。     

宁波市1988～2003年疫苗效力及冷链运转效果评价

为了解我市运输贮存时间内疫苗效力,在1988～2003年的3～6月对疫苗进行效价测定.     

Vaccine provision: Delivering sustained & widespread use

The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency). The ultimate aim is to make sure that an immunogenic product matching the required specifications reaches the recipient.The process from concept to licensure takes 10–30 years. Vaccine licensure is based on a file submitted to regulatory agencies which contains the comprehensive compilation of chemistry, manufacturing information, assay procedures, preclinical and clinical trial results, and proposals for post-licensure effectiveness and safety data collection. Expedited development and licensure pathways may be sought in emergency settings: e.g., the 2009 H1N1 influenza pandemic, the 2014 West African Ebola outbreak and meningococcal serogroup B meningitis outbreaks in the United States and New Zealand.Vaccines vary in the complexity of their manufacturing process. Influenza vaccines are particularly challenging to produce and delays in manufacturing may occur, leading to vaccine shortages during the influenza season. Shortages can be difficult to resolve due to long manufacturing lead times and stringent, but variable, local regulations.New technologies are driving the development of new vaccines with simplified manufacturing requirements and with quality specifications that can be confirmed with fewer tests. These technologies could have far-reaching effects on supply, cost of goods, and on response timing to a medical need until product availability.     

Improving cold chain systems: Challenges and solutions

While a number of new vaccines have been rolled out across the developing world (with more vaccines in the pipeline), cold chain systems are struggling to efficiently support national immunization programs in ensuring the availability of safe and potent vaccines. This article reflects on the Clinton Health Access Initiative, Inc. (CHAI) experience working since 2010 with national immunization programs and partners to improve vaccines cold chains in 10 countries—Ethiopia, Nigeria, Kenya, Malawi, Tanzania, Uganda, Cameroon, Mozambique, Lesotho and India – to identify the root causes and solutions for three common issues limiting cold chain performance. Key recommendations include:

• (1)To address cold chain capacity:
  • •developing an accurate picture of cold chain capacity gaps based on current and future needs;
  • •resource mobilization, and;
  • •effective monitoring during implementation.
• (2)To encourage upgrade of cold chain with latest technology suitable in country:
  • •in-country piloting of new equipment;
  • •utilization of tools to better understand equipment trade-offs, and;
  • •guide equipment selection and regular engagement with suppliers.
• (3)To control temperature excursions and equipment breakdowns
  • •introduction of temperature monitoring and control (TMC) devices and practices;
  • •improve competence and availability of existing and future technicians, and;
  • •ensure availability of spare parts.

Collectively, the solutions detailed in this article chart a path to substantially improving the performance of the cold chain. Combined with an enabling global and in-country environment, it is possible to eliminate cold chain issues as a substantial barrier to effective and full immunization coverage over the next few years.     

应用冷链监测卡开展全国冷链系统评审的结果与分析

１９９２年１２月～１９９３年１２月，卫生部疾病控制司应用冷链监测卡，对全国省（自治区、直辖市，下同）、地区（市、州、盟，下同）、县（区、市、旗，下同）级冷链系统进行了评审，对脊髓灰质炎（脊灰）疫苗（ＯＰＶ）从生物制品研究所（生研所）出厂到省级、地区级和县级卫生防疫站的运输与贮存情况进行了监测，发现了省、地区、县级冷链系统的薄弱环节，为今后冷链设备的装备与更新提供了依据。全国共下发３０４３张冷链监测卡，截至１９９４年５月止，共收到２５个省的１７１０张卡，返回率为６０３４％。运输环节中从生研所到省运输期间监测卡的变色率最高，高于省到地区及地区到县。贮存环节中，省级的变色率低于地区，地区低于县     

运用信息化手段建设疫苗冷链监测系统

根据疫苗冷链环节存在的事故隐患,本文提出了运用信息化手段建设疫苗冷链监测系统来完善疫苗流通监管的设想,并从必要性和可行性两方面进行了分析。     

流行性感冒病毒裂解疫苗安全性与免疫原性研究

目的评价流行性感冒（流感）病毒裂解疫苗的安全性和免疫原性。方法按随机抽样原则,采用单一中心、开放式、接种l剂流感病毒裂解疫苗免疫的方法,开展临床试验。结果观察对象接种1剂后局部反应发生率为0．6％：发热反应发生率4．52％,且以轻度发热为主。血清学检测结果表明,接种疫苗后,流感病毒甲1、甲3、乙（亚）型的血凝抑制（Haemagglutination Inhibition,HAI）抗体总阳转（≥1：40）率分别为95．0％、87．1％、88．1％;HAI抗体几何平均滴度（Geometric Mean Titer,GMT）增长倍数分别为33．28倍、7．76倍、26．04倍;抗体保护率分别为100．0％、99．7％、98．4％。三个型别之间抗体阳转率、GMT增长倍数、保护率的差异有显著的统计学意义。结论国产流感病毒裂解疫苗应用于≥3岁人群是安全的,免疫效果显著。     

Integration of vaccine supply chains with other health commodity supply chains: A framework for decision making

One of the primary objectives of National Immunization Programs is to strengthen and optimize immunization supply chains so that vaccines are delivered to the end recipients effectively, efficiently and sustainably. As a result of larger investments in global health and a wider portfolio of vaccines, global agencies are recognizing the need for vaccine supply chains to operate at their most optimal levels. Integration with other supply chains is often presented as a strategy to improve efficiency. However, it remains unclear if the proposed benefits from integration of vaccine supply chains with other supply chains will outweigh the costs. This paper provides a framework for deciding where such integration offers the most significant benefits. It also cautions about the pitfalls of integration as a one size fits all strategy. It also highlights the need for systematic collection of cost and efficiency data in order to understand the value of integration and other such initiatives.     

《疫苗管理法》下疫苗生产环节的法律问题探索

疫苗生产安全事故给疫苗接种带来了严重的信任危机,为此,《疫苗管理法》对疫苗生产安全作出新的规定。从疫苗生产环节入手,将《疫苗管理法》中有关生产环节的规定与《药品管理法》《药品管理法实施条例》《药品生产质量管理规范》《药品生产监督管理办法》中关于生产环节的规定予以比较,并分析新法的进步性,提出完善《疫苗管理法》关于生产环节的建议:进一步完备疫苗生产准入制度细则,完善疫苗上市许可持有人制度,明晰支持疫苗产业发展的法律规定,明确疫苗生产监管责任。     

Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries

IntroductionThis study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain.MethodsSemi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels.ResultsChallenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines.ConclusionParticipating immunization stakeholders recognized the benefits of vaccine products with improved stability characteristics and of labeling vaccines for controlled-temperature chain use as a means to help address cold-chain issues in their immunization programs.