新疫苗纳入国家免疫规划的评价维度及指标分析

目的 对新疫苗纳入国家免疫规划涉及的决策要素相关的文献进行系统梳理。方法 通过8个中英文文献数据库检索国内外相关文献,归纳各国进行免疫决策时的评价维度及核心指标等。结果 纳入41篇文献,内容以案例研究为主,实证研究较少。各文献基本遵循疾病、疫苗、卫生系统的评价框架,但有不同程度的延伸。疾病死亡率、疫苗安全性及有效性、成本效果评价等为高频评价指标。本研究梳理出基于“疾病-疫苗-能力-效益评价”的4维度13个要素43个指标的评价体系。结论 国内外关于疫苗决策的研究处于发展阶段,我国应增强疫苗纳入免疫规划的评价框架的可操作性及广度,注重本土的流行病学、卫生经济学数据收集,进一步发挥国家免疫规划技术工作组在疫苗循证决策中的作用。     

中国2012年国家免疫规划疫苗常规免疫报告接种率分析

目的分析2012年中国（未包括香港、澳门特别行政区和台湾地区,下同）国家免疫规划（NationalImmunizationProgram,NIP）疫苗常规免疫接种率监测报告,提出改进建议。方法通过描述性分析结合比值（Ratio,R值）评价,对2012年全国省（自治区、直辖市,下同）、县（区、市、旗、兵团师,下同）、乡（镇、街道、社区、兵团团场,下同）NIP疫苗常规免疫接种率监测报告接种率、报告数据质量进行分析评价。结果2012年全国常规免疫接种率监测报告县、乡报告率分别为97．87％和97．57％。2012年全国报告接种NIP疫苗共计387683777剂,全国22剂NIP疫苗报告接种率均≥99％,乙型肝炎疫苗首剂（TheFirstDoseofHepatitisBVaccine,HepB．）及时报告接种率95．74％。全国90．4％的县、79-3％的乡所有剂次NIP疫苗报告接种率〉90％,HepB．及时接种率≥90％的县、乡分别占87．0％、73．2％。报告接种率〈90％的县、乡主要分布于西藏、青海、内蒙古、新疆等西部地区。全国NIP疫苗以县为单位各剂平均报告接种率,除HepB．及时接种率、A＋C群脑膜炎球菌多糖疫苗第2剂、白喉．破伤风联合疫苗外,其余均≥98％。全国NIP疫苗22剂报告接种率以乡为单位总和平均为96．59％。中部地区最高（98．40％）,西部地区最低（94．26％）。全国33．8％的县白喉．破伤风一百日咳联合疫苗（Diphtheria．TetanusandPertussisCombinedVaccine;DTP）的脱漏率〉5％,8．99％的县DTP脱漏率≥10％,主要分布在中、西部地区。尺值评价结果显示,对应儿童不同年龄段疫苗剂次,可信度有所变化,其中36-48月龄段数据似可信度最高,其次为12月龄和18～24月龄段,儿童6岁段报告数据似可信度最低。结论全国NIP疫苗常规免疫接种率监测报告完整性和报告接种率均处于较高水平。全国省、县、乡报告接种率水平总体趋于一致,且处于较高水平,但地域差异依然存在,报告接种率较低的县、乡主要分布在西部地区。当前监测数据报告质量有待改善,直接识别低接种率地区能力较弱,需结合各地疾病监测、疫苗使用情况和接种率调查结果,综合评价各地接种率水平。     

基于疫苗全程电子追溯体系的河南省国家免疫规划疫苗损耗分析

目的：通过疫苗电子追溯体系精准测算河南省国家免疫规划疫苗的损耗情况,为进一步实现精细化疫苗管理、合理降低疫苗损耗提供科学依据。方法：利用河南省免疫规划信息管理系统省级平台及疫苗电子追溯系统收集2021年河南省预防接种门诊疫苗接种数据和使用数据。利用国家全民健康保障系统收集河南省预防接种门诊服务周期、服务半径等数据。结果：2021年河南省单剂次包装疫苗的损耗系数在1.01～1.06之间,最大为乙肝疫苗;多人份疫苗损耗系数在1.45～1.92之间,最大为卡介苗。2021年河南省不同市（县） 11种国家免疫规划疫苗的损耗系数存在一定差别。多数国家免疫规划疫苗的损耗系数在不同服务周期、不同服务半径、不同服务人口、不同门诊工作人员数量的接种门诊间存在一定差别。结论：除乙肝疫苗外,河南省其他国家免疫规划疫苗损耗系数均小于国家标准,说明河南省疫苗损耗管理相对较好,达到了国家工作要求。多人份疫苗和个别单人份疫苗损耗较大,应合理安排门诊周期,将接种日当天的接种人口密度控制在合理范围内,以提高疫苗利用效率。     

外来儿童国家免疫规划疫苗预防接种现状研究

目的 为建立中小城市外来人员的传染病预防控制的模式提供依据。方法问卷调查荆州城区本地居民和外来人员0～6岁儿童预防接种情况。结果调查0～6岁儿童193名，100％本地儿童有预防接种证．88．9％外地儿童有预防接种证（P〈0．05）；5种疫苗全程合格接种率本地儿童为94．0％，外地儿童为83．80％（P〉0．05）。127例麻疹病例以托幼儿童、散居儿童、学生为主，占总病例数的90．26％．麻疹疫苗接种1针次占14．00％，接种2针次及以上者占8．00％，未接种占30．00％，接种史不详者占48. 00％。结论外来人员儿童国家免疫规划疫苗预防的总体接种率低于城市本地儿童，外来人员儿童计免服务应纳入政府管理．     

湖北省部分免疫规划疫苗免疫成功率监测分析

目的了解湖北省免疫规划疫苗接种后免疫效果,为制定湖北省免疫规划策略提供科学依据。方法选取湖北省3个县(市)开展免疫规划疫苗免疫成功率监测,分别监测目标人群百白破(DTaP)、麻风(MR)、麻腮风(MMR)、乙脑(JEV-L)、脊灰(OPV)5种疫苗针对疾病的疫苗免疫效果。结果 DTaP中百日咳、白喉、破伤风免疫成功率为38.00%、100%、100%,免疫前后,百日咳抗体阳性率差异无统计学意义(χ~2=3.048,P0.05),白喉和破伤风抗体阳性率差异均有统计学意义(白喉:χ~2=100.00,P0.01;破伤风:χ~2=88.679,P0.01);MR中麻疹、风疹免疫成功率为100%、98.00%,免疫前后,麻疹和风疹抗体阳性率差异均有统计学意义(麻疹:χ~2=92.308,P0.01;风疹:χ~2=6.737,P0.05);MMR中麻疹、流腮、风疹免疫成功率均为100%,免疫前后,麻疹抗体阳性率差异有统计学意义(χ~2=8.701,P0.05),流腮和风疹抗体阳性率差异均无统计学意义(χ~2=0.000,P0.05);JEV-L中乙脑免疫成功率为76.00%,免疫前后,乙脑抗体阳性率差异有统计学意义(χ~2=57.545,P0.01);OPV中脊灰免疫成功率为96.00%,免疫后,脊灰Ⅰ型中和抗体阳性率和Ⅲ型中和抗体阳性率均无统计学意义(χ~2=0.000,P0.05)。结论 5种疫苗免疫成功率总体良好,但有必要优化百日咳菌苗和乙脑疫苗免疫程序,提升疫苗抗体免疫成功率,才能降低相关疾病的发病风险。     

世界卫生组织194个成员国肺炎球菌疫苗纳入国家免疫规划现况分析

目的 分析世界卫生组织（World Health Organization,WHO） 194个成员国的肺炎球菌疫苗（pneumococcal vaccine,PV）纳入国家免疫规划（National Immunization Program,NIP）现况,为优化调整我国PV免疫策略提供科学依据。方法 收集WHO六大区域内194个成员国的PV免疫程序、疫苗类型及目标人群接种率等公开数据,进行描述性分析。结果 在194个WHO成员国中,有163个国家至少将1种PV纳入儿童、成人或高危人群的NIP,其中156个国家将PV纳入儿童NIP,40个国家纳入高危人群NIP,28个国家纳入成人NIP。全球主要使用的3种PV中,10价肺炎球菌结合疫苗（pneumococcal conjugate vaccine,PCV）已纳入39个国家的NIP,13价PCV已纳入133个国家的NIP,23价肺炎球菌多糖疫苗（pneumococcal polysaccharide vaccine,PPV）已纳入44个国家的NIP。针对儿童PCV免疫程序,147个国家采用的是3剂次免疫程序,17个国家使用4剂次免疫程序,另...     

中国免疫规划用疫苗十年发展状况及趋势分析

免疫规划用疫苗在中国传染病预防控制方面起到举足轻重的作用。我国自2007年实施扩大免疫规划以来, 免疫规划用疫苗共计15种, 可以预防15种疾病。本文从品种、数量、生产企业、质量标准、监管体系5个方面详细分析了近十年中国免疫规划疫苗的发展状况。研究结果显示, 2011—2020年中国免疫规划用疫苗平均剂量约为5.7亿剂次/年;免疫规划用疫苗行业整体发展平稳, 每类疫苗生产企业在1～5家之间且主要依靠国内生产;疫苗质量标准不断提高且与国际标准基本一致;疫苗监管体系不断完善, 覆盖了研发、生产、流通全流程监管。     

疫苗纳入国家免疫规划论证的优先性研究

疫苗研发上市使越来越多的疾病可通过疫苗接种来预防。在多种非免疫规划疫苗可选择的情况下,新疫苗纳入国家免疫规划(National Immunization Program, NIP)论证的优先顺序,需要科学合理的机制来确定。本研究使用改良德尔菲法(Modified Delphi technique, MDT)开展疫苗纳入NIP论证的优先性研究。2021年1-5月,我们进行文献综述并参考世界卫生组织关于疫苗纳入NIP考虑因素,梳理出备选指标框架,邀请39名专家开展两轮德尔菲法专家咨询,并建立一套评价指标体系。在第三轮专家咨询中,30名专家应用建立的指标体系对5种候选疫苗进行评分,确定疫苗纳入NIP论证的优先顺序。三轮咨询专家积极系数分别为100%(39/39)、97.44%(38/39)和100%(30/30),专家权威系数均>0.70,说明专家咨询结果可靠;各级指标重要性评分和5种候选疫苗评分的一致性检验均具有显著性(P<0.001),说明不同专家的评分水平具有一致性。5种候选疫苗纳入NIP论证的顺序评分(范围从1分到10分)依次为水痘减毒活疫苗(6.91分)、脑膜炎球菌多糖...     

2006年各国纳入免疫规划疫苗概况

目的利用描述性分析方法,对各国使用的免疫规划疫苗情况进行分析,截止2006年192个国家共有53种疫苗纳入了免疫规划,中国具备生产能力的有28种。中国与其它国家相比,纳入免疫规划的疫苗种类少,且比较陈旧。因此,更新和扩大中国免疫规划使用的疫苗成为当务之急。     

灵川县儿童免疫规划疫苗及时接种率及干预效果分析

目的分析桂林市灵川县儿童免疫规划疫苗及时接种情况,分析其影响因素并及时采取有效措施。方法采用随机整群抽样的方法,抽取灵川县县城及12个乡镇的儿童进行免疫规划疫苗及时接种情况调查,并开展电话催约、村医上门发通知催约、缩短接种服务周期、疫苗知识讲座和宣传等的联合干预措施。评价干预前后疫苗及时接种率情况的变化。结果采取干预措施后,BCG(86.00%vs 92.06%,χ~2=22.754,P0.001)、HepB(89.96%vs 95.32%,χ~2=24.328,P0.001)、OPV(89.15%vs 94.44%,χ~2=20.872,P0.001)、DPT(81.01%vs93.68%,χ~2=78.494,P0.001)、MR(87.68%vs 93.09%,χ~2=16.123,P0.001)、MenA(57.70%vs 89.61%,χ~2=257.271,P0.001)的及时接种率均高于干预前,且差异均有统计学意义;未及时接种原因主要是因为家长忘记时间(73.80%,369名),孩子生病(11.80%,59名)和有事情耽搁(11.20%,56名)。结论我县儿童免疫规划疫苗及时接种情况不甚理想,主动开展如电话催约、村医上门发通知催约、缩短接种服务周期、疫苗知识讲座和宣传等的联合干预措施可有效提高我县儿童免疫规划疫苗及时接种率。     

Incorporation of health economic evaluation into immunization policy-making in Canada: Barriers and facilitators

IntroductionDespite the WHO recommendation that economic evidence be considered in national vaccine recommendations, this element of decision-making has been lacking or not done routinely in Canada. This study aimed to investigate barriers and facilitators to using economic evaluations in public health immunization programs decision-making across Canadian jurisdictions.MethodsThis mixed methods study consisted of a cross-sectional survey and semi-structured interviews of national, provincial and territorial public health level key informants, and of members of the national immunization research network in Canada. Barriers were categorized according to accessibility (e.g. access to human resources to conduct the evaluation) and acceptability (e.g. political resistance to using the evaluation).ResultsOf 63 survey participants, 12 were federal, provincial or territorial key informants (response rate 12/31, 39%) and 51 were members from the research network (response rate 51/214, 24%). Eleven stakeholders gave semi-structured interviews. All respondents support increased use of economic evaluation and of it becoming a routine part of immunization policy-making. However, 70% of the survey respondents identified limited resources (human and financial) to perform economic evaluations, and 39% reported lack of expertise to interpret economic evidence. Vaccine effectiveness and the burden of disease were seen as more important than cost-effectiveness by survey respondents and interviewees. Potential facilitators were for economic evaluations to either be conducted at the national level, or through a collaboration between provinces and territories with capacity to address shared needs so that evaluations occurred in a co-ordinated but distributed way.Recommendations:Barriers to incorporation of economic evaluation in immunization policy-making in Canada include lacking human and financial resources to conduct them and understanding of economic evidence. National, provincial and territorial public health actors reported that facilitators to incorporating economic evidence include developing increased capacity to conduct and use economic evaluations and establishing inter-jurisdictional systems to share the work of conducting economic evaluation and/or by national leadership.     

无锡市含腮腺炎成分疫苗纳入国家扩大免疫规划对流行性腮腺炎发病影响

目的 分析2004-2020年无锡市流腮的流行特征,为进一步制订流腮的防控策略提供参考依据.方法 2004-2020年流腮发病情况来源于中国疾病预防控制信息系统,人口学资料来源于无锡市统计年鉴.采用描述流行病学方法对无锡市2004-2007年[麻疹-流行性腮腺炎-风疹联合减毒活疫苗(MMR疫苗)纳入扩大国家免疫规划(E...     

WHO Guide for standardisation of economic evaluations of immunization programmes

Traditional EPI vaccines are considered to be among the most efficient uses of scarce health care resources. Today, there are many under-used and new vaccines available. In the short- to medium-term, these vaccines will not cost the few cents per dose the traditional vaccines do, but will be ‘multi-dollar’ vaccines. Decision-makers will need information, among other things, on their relative cost-effectiveness. A number of reviews have indicated that there is scope for improving the transparency, completeness and comparability of economic evaluations of vaccination programmes. Thus, there is a need to improve the quality of economic evaluations of vaccination programmes. Adherence to general guidelines would increase the quality, interpretability and transferability of future analyses. However, there is reason to believe that there might also be a need for more specific advice for vaccination programmes. For example, there are inconsistencies in the methods used to estimate the future benefits of vaccination programmes and the relative efficiency of these programmes can be sensitive to some of the more controversial aspects of general guidelines, such as the inclusion of indirect costs and the discounting of health outcomes. This guide has been developed in order to meet the needs of decision-makers for relevant, reliable and consistent economic information. They aim to provide clear and concise, practical and high quality guidance for those who conduct economic evaluations.     

Use of economic evaluation guidelines: 2 years' experience in Canada

Considerable effort has been expended in recent years in the development of methodology guidelines for economic evaluation of pharmaceutical products, driven in part by the desire to improve the rigour and quality of economic evaluations and to help decision making. Canada was one of the first countries to develop such guidelines and to encourage their use. This paper examines the extent to which the economic evaluations that were submitted to the Canadian Coordinating Office for Health Technology Assessment in the last two years adhered to Canadian guidelines. The analytic technique employed by twelve studies as well as the comparator used, the perspective taken, the outcome measure selected, the cost items that were taken into consideration and the extent of sensitivity analyses that were performed are reviewed in this paper. It can be concluded that although studies have been of variable quality, the majority of them were well presented, complete and transparent, due in part to the guidelines. Except for the perspective of the analysis, guidelines were, in many respects, adhered to and did not restrict investigators to specific methodologies or specific techniques. They were also instrumental in ensuring a minimum set of standards. © 1998 John Wiley & Sons, Ltd.     

Economic impact of the introduction of an acellular pertussis vaccine in Canada: A 6-year analysis

Background

Between July 1997 and April 1998, Canadian public health agencies switched from the whole cell vaccine to the acellular vaccine for pertussis immunization. The acellular vaccine provided better efficacy and fewer adverse events than the whole cell vaccine did.

Objective

To determine the economic impact of replacing the whole cell vaccine with an acellular vaccine in Canada.

Methods

A decision analytic model was developed comparing costs and outcomes of pertussis vaccination for Canadian children born in the years 1991–2004. Effectiveness was measured as number of avoided pertussis cases as well as the number of avoided hospital admissions. Incremental costs per avoided pertussis case and per avoided hospital admission were calculated for Ministry of Health (MoH) and societal (SOC) perspectives. Various one-way sensitivity analyses as well as a Monte Carlo simulation were performed by varying key model parameters.

Results

The switch in immunization programs resulted in an incremental cost to the MoH of CAD $108 per pertussis case avoided (CAD $0.96 per child-year). From the SOC perspective, there was a savings of CAD $184 per pertussis case avoided (CAD $0.13 per child-year). The one-way sensitivity analyses provided incremental cost-effective ratios (ICERs) ranging from an incremental cost of CAD $1034 per avoided pertussis case from the MoH perspective to a saving of CAD $1583 per avoided case from the SOC perspective. The Monte Carlo simulation confirmed the robustness of these results.

Conclusions

Pertussis vaccination with AcE was cost-saving from the societal perspective and cost-effective from the Ministry of Health perspective.     

Systematic review of economic evaluation analyses of available vaccines in Spain from 1990 to 2012

Objective

The objective of this survey was to describe the evolution of economic evaluation studies on vaccines available in Spain.

Methods

We conducted a systematic review of the economic evaluations published by Spanish researchers in major bibliographic databases available online from 1990 to 2012. For all references identified, we limited them to full economic evaluation carried out in Spanish vaccine programs. The following variables were analyzed: type of study, year of publication, vaccine evaluated, the herd immunity and the main methodological aspects proposed by international guidelines. The type of vaccines studied were Hepatitis A and B, Rotavirus, Influenza, Varicella, Tetanus, Measles, Human papillomavirus, Streptococcus pneumoniae infection and Neisseria meningitides serogroup C infection.

Results

A total of 34 references was included in the study. The number of economic evaluations has been increasing over the years by 86%. For many of the vaccines there were no economic evaluations, while others such as the vaccine against S. pneumoniae infection took up most of the studies. The non-vaccinated comparison was the most used strategy. The cost-effectiveness model was selected in 60% of cases. The most common health outcome was “cost per case prevented” and in 82% of the studies did not consider herd immunity. The results showed a cost-effectiveness ratio which was below breakeven.

Conclusions

It is clear that the existence of a huge gap in this kind of work compared to other countries. Although the quality of the work discussed here was significant, we found many areas which could be improved. The reviewed literature exposed the great benefit of vaccination for society by analysing the health outcomes achieved for decades since its implementation. However, the evidence on the efficiency and effectiveness vaccination is not very high, and there are few studies about economic evaluation.     

Inclusion of intersectionality in studies of immunization uptake in Canada: A scoping review

IntroductionIntersectionality refers to the interconnectedness of various social locations creating unique experiences for individuals and groups, in the context of systems of privilege and oppression. As part of immunization coverage research, intersectionality allows healthcare professionals and policymakers to become aware of the constellation of characteristics contributing to low vaccine uptake. The objective of this study was to examine the application of intersectionality theory or concepts, and the appropriate use of sex and gender terminology, in Canadian immunization coverage research.Materials and methodsThe eligibility criteria for this scoping review included English or French language studies on immunization coverage among Canadians of all ages. Six research databases were searched without date restrictions. We searched provincial and federal websites, as well as the Proquest Dissertations and Theses Global database for grey literature.ResultsOf 4725 studies identified in the search, 78 were included in the review. Of these, 20 studies included intersectionality concepts, specifically intersections of individual-level characteristics influencing vaccine uptake. However, no studies explicitly used an intersectionality framework to guide their research. Of the 19 studies that mentioned “gender”, 18 had misused this term, conflating it with “sex”.ConclusionsBased on our findings, there is an evident lack of intersectionality framework utilization in immunization coverage research in Canada, as well as misuse of the terms “gender” and “sex”. Rather than only focusing on discrete characteristics, research should explore the interaction between numerous characteristics to better understand the barriers to immunization uptake in Canada.     

Development and release of a national immunization app for Canada (ImmunizeCA)

Digital technology has created an opportunity to reenvision the traditional immunization paper record. We describe our experience developing a government endorsed mobile immunization record in Canada. The smartphone app, ImmunizeCA is designed to assist individuals in managing their own health information. It allows individuals to store their and their family's immunization records on their smartphone. The app, which is populated by data provided by the user, contains all 13 provincial and territorial schedules, immunization information and outbreak alerts on vaccine preventable diseases. Our experience suggests mobile apps can serve as a mechanism to empower users, increase participation in the process of immunization, potentially improve immunization rates and address jurisdictional obstacles. Key measures of success will include long term uptake, acceptability as an official record, enabling data flow permitting integration with immunization information systems and the ability to rapidly iterate to address changes to both immunization practice and mobile technology.