基于德尔菲法及层次分析法构建免疫规划疫苗遴选评估框架

目的 构建非免疫规划疫苗纳入深圳市免疫规划的评估框架。方法 通过文献分析，初步形成指标框架；于2022年3—7月采用2轮德尔菲专家咨询法对15名专家进行问卷调查(，以)修改完善指标，确定指标体系；采用层次分析法确定指标权重。结果 2轮专家咨询的专家积极系数C_aj专家权威系数(Cr)均值为0.84；第一轮、第二轮专家咨询所有指标综合评分的协调系数(W)分别在0.199～0.465、0.253～0.442之间(P均<0.05)；最终确定了由4个一级指标、13个二级指标和34个三级指标形成的指标体系，分别从疾病评价(疾病负担、经济负担、防控优先性)、疫苗评价(疫苗安全性、疫苗效果、疫苗属性)、能力评价(决策过程、资金、供应、人力、监测)和效益评价(经济效益、社会效益)等4个维度进行评价，其中所有三级指标的组合权重系数在0.003～0.279。结论 本研究构建的深圳市免疫规划疫苗遴选评估框架具有创新性与可靠性，可为深圳市免疫规划疫苗遴选提供参考。     

b型流感嗜血杆菌疫苗纳入免疫规划的卫生经济学研究系统评价

目的对b型流感嗜血杆菌(Hib)疫苗纳入免疫规划(EPI)的卫生经济学研究文献进行系统评价。方法通过8个中英文文献数据库检索国内外Hib疫苗卫生经济学研究文献,对纳入文献进行信息提取,归纳Hib疫苗经济学研究的方法、设计和研究结果。结果共纳入32篇文献,其中25篇从全社会角度进行研究;26篇的研究对象为5岁或1岁儿童;均采用成本-效果分析(CEA)、成本-效益分析(CBA)和/或成本-效用分析(CUA);均使用静态模型。27篇文献(包括在中国研究的2篇文献)认为Hib疫苗纳入国家免疫规划具有经济学效益,即节约社会成本;5篇文献认为不具有经济学效益。结论本系统评价显示Hib疫苗纳入免疫规划通常具有经济学效益;建议中国针对Hib疫苗纳入国家免疫规划进行高质量的卫生经济学研究。     

基于需求和经济学评价证据的HPV疫苗 纳入免疫规划可行性探讨

人乳头瘤病毒(humanpapillomavirus,HPV)感染是宫颈癌发生的必要条件,HPV疫苗对宫颈癌预防和控制有重要的健康和经济影响。鉴于宫颈癌疾病负担的严重性以及HPV疫苗预防的有效性和安全性,HPV疫苗接种纳入我国免疫规划的可行性引发很多探讨,亟需来自实践的证据支持。本研究从HPV疫苗接种需求(包括认知和偏好)和经济学评价两个维度对国内外相关研究进行分析评价,以期为HPV疫苗纳入免疫规划的可行性提供证据支持,并进一步启示未来研究。     

灭活脊髓灰质炎病毒疫苗和口服脊髓灰质炎减毒活疫苗不同免疫策略经济学评价的系统综述

目的系统综述灭活脊髓灰质炎(脊灰)病毒疫苗(Inactivated Poliovirus Vaccine,IPV)和口服脊灰减毒活疫苗(Oral Poliomyelitis Attenuated Live Vaccine,OPV)不同免疫策略经济学评价方法的研究现状。方法检索数据库中所有使用经济学评价方法,比较两种脊灰疫苗免疫策略的文献并进行系统综述。结果共纳入12篇文献。关于脊灰疫苗不同免疫策略的经济学评价研究尚不规范,尤其成本构成的界定差别较大,缺乏疾病流行数学模型的应用,以及效果指标判定阈值的研究。不同经济水平国家或地区使用IPV替代OPV免疫策略是否具有成本效果优势,纳入文献结论存在不一致性。结论脊灰疫苗免疫策略的经济学评价是动态、复杂的过程,评价我国免疫规划引入IPV不同免疫程序的成本效果很有意义。     

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...     

中国和亚洲部分其他国家疫苗配送管理的比较分析

[目的]比较日本、泰国、越南和我国的免疫框架和配送管理状况,分析我国疫苗管理中存在的不足,探索完善我国免疫规划的政策.[方法]通过对文献、政府文件等相关资料的梳理和评阅,对我国和日本、泰国、越南从免疫规划和疫苗配送管理实践的现状进行比较.[结果]日本是信息化技术在疫苗配送管理中应用比较好的国家之一,泰国在将疫苗供应管理...     

公共卫生体系要素的确认与研究

目的明确公共卫生体系要素,建立体系的理论框架。方法系统评阅国内外公共卫生体系相关文献394篇,以卫生系统宏观模型为逻辑推演框架,对公共卫生体系的研究方面及要素进行定量研究。结果共梳理出公共卫生体系的25个研究方面,与理论模型的概念维度相互匹配,据此总结归纳为8个要素,认可率达88.8%~93.3%。其中,文献研究对于组织体系、把握公众需要及资源配置3个要素的关注程度最高,关注指数分别为0.245、0.170、0.158。结论公共卫生体系的要素及相互关系,全面反映了体系的组成和运作规律,为公共卫生体系的研究提供了科学的理论框架,可指导体系评价标准的构建与公共卫生领域的政策制定。     

中英疫苗采购、配送及监测比较

目的 比较中英两国的免疫接种系统及工作程序,以期为我国免疫接种工作提供借鉴和启示.方法 通过文献回顾和网站信息收集,系统梳理中英两国疫苗采购、配送和异常反应监测的相关政策、文件、新技术应用等信息.结果 在疫苗采购方面,两国纳入国家免疫规划的疫苗均由政府统一采购、免费接种,且中国实行强制接种政策.在疫苗配送方面:英国全境...     

江西省扩大国家免疫规划实施效果评价

<正>为贯彻全国人大十届五次会议提出的"扩大国家免疫规划范围,将甲肝、流脑等15种可以通过接种疫苗有效预防的传染病纳入国家免疫规划"的精神,依照卫生部《关于实施扩大国家免疫规划的通知》要求,江西省于2008年开始实施扩大国家免疫规划(以下简称扩免)工作。此项工作得到江西省委、省政府高度重视,并将其纳入省政府民生工程以确保全省儿童享受到国家免疫规划疫苗免费接种政策。本研究通过对全省11个设区市进行扩大免疫规划督导调查和2009年免疫规划经费投入、冷链设备、人员构成及疫苗接种率等情况的调查,评价两年来实施扩大国家免疫规划的效果。     

整合型医疗健康服务体系理论框架的核心要素与演变特点 ——基于系统综述

目的:归纳总结国内外整合型医疗健康服务体系理论框架的基本特征、主要维度及核心要素,分析演变特点及启示.方法:采用系统综述法检索并筛选文献,依据前期研究提出的制度整合、组织整合、专业整合、服务整合、核心功能整合、价值规范整合6个维度,利用主题框架法提取和分析文献资料.结果:纳入分析的66个理论框架中,12个聚焦单一维度、...     

National decision-making on adopting new vaccines: a systematic review

In recent years numerous new vaccines have been developed, offering potential reductions in the morbidity and mortality caused by a range of diseases. This has led to increased interest in decision-making about the adoption of new vaccines into national immunization programmes. This paper aims to systematically review the literature on national decision-making around the adoption of new vaccines. A thematic framework was developed inductively through analysis of the vaccine adoption decision-making frameworks included in the review. This thematic framework was then applied to the remaining studies included in the review. In total, 85 articles were included in the review: 39 articles describing examples of vaccine adoption decision-making, 26 presenting vaccine decision-making frameworks, 21 empirical articles of decision-making relating to vaccine adoption and 19 theoretical essays. An analysis of vaccine adoption decision-making frameworks identified nine broad categories of criteria: the importance of the health problem; vaccine characteristics; immunization programme considerations; acceptability; accessibility, equity and ethics; financial/economic issues; impact; alternative interventions and the decision-making process. The quality of the empirical studies was varied. Although some of the issues included in the frameworks were similar to those considered in the studies, there were also some notable differences. On the whole, the frameworks were more comprehensive than the studies, including a greater range of criteria. The existing literature provides a good foundation for further research into vaccine adoption decision-making. The current review, in pulling together what is already known and by identifying strengths, weaknesses and gaps in the existing evidence base, aims to encourage a more focused and rigorous approach to the topic in future. This could help to identify the most appropriate ways to develop vaccine adoption decision-making, so as to improve decisions and, ultimately, health outcomes.     

慢性阻塞性肺疾病患者流感疫苗和23价肺炎球菌多糖疫苗接种研究进展

近年来国内外慢性阻塞性肺疾病（COPD）患者流感疫苗和23价肺炎球菌多糖疫苗（PPV23）接种有效性的相关研究发现,接种流感疫苗和PPV23可显著降低COPD患者的流感和肺炎感染风险,减少疾病的急性加重以及与之相关的住院,尤其是接种流感疫苗还可降低患者诱发缺血性心脏病、急性冠脉综合征、室性心律失常、肺癌、痴呆和死亡的风险,二者联合接种保护作用更加显著。国内外权威指南、共识均建议COPD患者接种流感疫苗和PPV23。目前国内流感疫苗和肺炎球菌疫苗接种率均偏低,且在COPD患者中的应用研究较少。应采取有效措施加强知识普及和指南宣传,提高疫苗接种率。同时还应进一步加强COPD患者接种流感和PPV23的临床研究,尤其是联合接种的临床效益分析,以切实改善COPD患者的生存现状和预后。     

National decision-making for the introduction of new vaccines: A systematic review, 2010–2020

BackgroundCompeting priorities make using a transparent and evidence-based approach important when deciding to recommend new vaccines. We conducted a literature review to document the processes and frameworks for national decision-making on new vaccine introductions and explored which key features have evolved since 2010.MethodsWe searched literature published on policymaking related to vaccine introduction from March 2010 to August 2020 in six databases. We screened articles for eligibility with the following exclusion criteria: non-human or hypothetical vaccines, the sole focus on economic evaluation or decision to adopt rather than policy decision-making. We employed nine broad categories of criteria from the 2012 review for categorization and abstracted data on the country, income level, vaccine, and other relevant criteria.ResultsOf the 3808 unique references screened, 116 met eligibility criteria and were classified as: a) framework of vaccine adoption decision-making (27), b) studies that analyse empirical data on or examples of vaccine adoption decision-making (45), c) theoretical and empirical articles that provide insights into the vaccine policymaking process (44 + 17 already included in the previous categories). Commonly reported criteria for decision-making were the burden of disease; vaccine efficacy/effectiveness, safety; impact on health and non-health outcomes; economic evaluation and cost-effectiveness of alternative interventions. Programmatic and acceptability aspects were not as often considered. Most (50; 82%) of the 61 articles describing the process of vaccine introduction policymaking highlighted the role of country, regional, or global evidence-informed recommendations and a robust national governance as enabling factors for vaccine adoption.ConclusionsThe literature on vaccine adoption decision-making has expanded since 2010. We found that policymakers and expert advisory committee members (e.g., National Immunization Technical Advisory Group [NITAG]) increasingly value the interventions based on economic evaluations. The results of this review could guide discussions on evidence-informed immunization decision-making among country, sub-regional, and regional stakeholders.     

Population access to new vaccines in European countries

Time from registration to population access to new vaccines can take considerable time in European countries. Reasons might be found in the regulatory framework, decision-making processes or the assessment of vaccines by evaluating bodies. The aim of this study was to determine whether some decision-making processes can explain between-country differences in the time to population access to new vaccination programs. Information gathered from a survey among European National Vaccine Industry Groups was combined with information from official health authorities, vaccine manufacturers and literature published. Firstly, a retrospective survey was conducted to measure access time to new vaccines against three diseases in 17 European countries. Secondly, qualitative information on the country-specific decision-making frameworks for the introduction of new “vaccination programs” was identified in a cross-sectional survey. Spearman's rank correlation coefficients (ρ) were used for data analysis. The median access time to new vaccines was 6.4 years (95% confidence interval: 5.7–7.1 years) post marketing authorization. National assessments underlying immunization policy decisions (recommendation phase) absorbed most of the access time. Correlation analysis suggested that processes with established timelines and clarity in regard to vaccine evaluation criteria used could ameliorate the effectiveness of the decision-making process. In order to reduce the time to access for new, beneficial vaccines, the underlying vaccination recommendation, implementation and funding process needs to be understood and optimized, where necessary.     

社区公共卫生应急能力指标体系构成要素研究

目的 探索社区公共卫生应急能力指标体系构成要素,为构建社区公共卫生应急能力评价指标体系提供参考依据。方法 研究利用系统文献检索和文本分析方法,对2003年“非典”以来突发公共卫生事件社区应急能力评价指标的中英文文献和相关政策文件进行分析,对科学性、相关性均较高文献中提出的要素进行了归纳整理,形成社区公共卫生应急能力指标体系构成要素框架。结果 本研究形成了社区公共卫生应急能力评价指标体系构成要素框架,包括6类一级要素和47项二级要素,可为进一步构建社区公共卫生事件应急能力指标体系提供参考。     

Conceptual frameworks and key dimensions to support coverage decisions for vaccines

BackgroundHealth policy makers often have to face decisions on whether and how to incorporate new vaccines into immunisation plans. This study aims to review and catalogue the relevant current frameworks and taxonomies on vaccines and connect these to the DECIDE Evidence to Decision framework (EtD), a general framework based on evidence-based criteria to guide decision-making on intervention adoption.MethodsWe systematically searched MEDLINE, EMBASE, Cochrane Library and funding agency websites from 1990 to 2013. We included systematic reviews and primary studies presenting decision-making tools for community vaccine adoption. We qualitatively summarised the reports by purpose, targeted country, principal results, and decisional models. We then extracted and compared the dimensions adopted by vaccine frameworks across studies.ResultsFourteen studies (five systematic reviews and nine primary studies) were included. Several factors frequently influenced decision-makers’ views on vaccines: the most frequent political-context factors considered were Importance of illness or problem, Vaccine characteristics, Resource use, and Feasibility. Others such as Values and preferences and Acceptability were less consistently reported. We did not find evidence on the reasons why a framework for vaccine adoption differs from that for decisions on the adoption of an intervention in general, such as the EtD. There are limited data on how dimensions are explained in practical factors and directly linked to coverage decisions.ConclusionsThis review summarises conceptual models and taxonomy of a heterogeneous and evolving area in health policy decisions. A shared and comprehensive framework on vaccine coverage remains to be achieved with its single dimensions (epidemiologic, effectiveness, economic, and social) valued differently across studies. A generic tool such as the EtD conceptualises all relevant dimensions, and might reduce inconsistencies.     

Decision support in vaccination policies

Background

Looking across boarders reveals that the national immunization programs of various countries differ in their vaccination schedules and decisions regarding the implementation and funding of new vaccines. The aim of this review is to identify decision aids and crucial criteria for a rational decision-making process on vaccine introduction and to develop a theoretical framework for decision-making based on available literature.

Methods

Systematic literature search supplemented by hand-search.

Results

We identified five published decision aids for vaccine introduction and program planning in industrialized countries. Their comparison revealed an overall similarity with some differences in the approach as well as criteria. Burden of disease and vaccine characteristics play a key role in all decision aids, but authors vary in their views on the significance of cost-effectiveness analyses. Other relevant factors that should be considered before vaccine introduction are discussed to highly differing extents. These factors include the immunization program itself as well as its conformity with other programs, its feasibility, acceptability, and equity, as well as ethical, legal and political considerations. Assuming that the most comprehensive framework possible will not provide a feasible tool for decision-makers, we suggest a stepwise procedure.

Conclusions

Though even the best rational approach and most comprehensive evaluation is limited by remaining uncertainties, frameworks provide at least a structured approach to evaluate the various aspects of vaccine implementation decision-making. This process is essential in making consistently sound decisions and will facilitate the public's confidence in the decision and its realization.     

National programme for the control of poliomyelitis

Oral polio vaccine was introduced into India's national immunization program in 1979-80. Coverage with this vaccine has increased rapidly from 0.67 million in 1979-80 to 9.63 million in 1984-85. 3 doses of the vaccine are recommended at age 3-12 months, followed by a booster dose 12-18 months later. The vaccine is administered along with the DPT vaccine. The vaccines are provided as a package of services under the expanded program on immunization (EPI). India's government initiated the EPI in 1978 with the goal of reducing the morbidity and mortality due to diphtheria, pertussis, tetanus, poliomyelitis, tuberculosis, and typhoid fever by making vaccination services available to all eligible children and pregnant women by 1990. In 1985-86, measles vaccination was included in the program. Another objective was to achieve self-sufficiency in the production of vaccines required for the program. Immunization services are provided through the existing health care delivery system: hospitals, dispensaries, and maternal and child health (MCH) clinics in the urban areas primary health centers in rural areas. The aim of universal immunization for all India has been set for 1989-90; some areas may achieve this goal earlier. 30 districts and catchment areas of 50 medical colleges have been taken up in the universal immunization program for 1985-86. The objectives of the universal immunization program include: to provide universal immunization coverage to pregnant women and to infants; to document a reduction in the vaccine preventable diseases; to develop effective implementation and to streamline logistics; and to encourage the active participation of the medical faculty, interns, and students from the planning to the evaluation stages. The government of India provides the vaccines required under the national immunization program to the state health authorities. Over 50 million doses of oral polio vaccine are expected to be utilized during 1985-86. The annual requirements are likely to exceed 80 million doses by 1989-90. The planned targets of vaccination coverage are linked closely to the development of the cold chain system. Since 1984 field samples of oral polio vaccine have been collected for potency tests in order to monitor the quality of the cold chain for vaccines. The effectiveness of the control measures will be evaluated by determining the vaccination coverage of the eligible population and by recording the reduction in incidence of poliomyelitis in the area.     

Archetype analysis of older adult immunization decision-making and implementation in 34 countries

The global population of adults over 65 years of age is growing rapidly and is expected to double by 2050. Countries will face substantial health, economic and social burden deriving from vaccine-preventable diseases (VPDs) such as influenza, pneumonia and herpes zoster in older adults. It will be essential that countries utilize several public health strategies, including immunization. Understanding the different approaches countries have taken on adult immunization could help provide future learnings and technical support for adult vaccines within life-course immunization strategies. In this study, we describe the priorities and approaches that underlie adult immunization decision-making and implementation processes in 32 high-and-middle-income countries and two territories (“34 countries”) who recommend adult vaccines in their national schedule. We conducted an archetype analysis based on a subset of two dozen indicators abstracted from a larger database. The analysis was based on a mixed-methods study, including results from 120 key informant interviews in six countries and a landscape review of secondary data from 34 countries. We found four distinct archetypes: disease prevention-focused; health security-focused; evolving adult focus; and, child-focused and cost-sensitive. The highest performing countries belonged to the disease prevention-focused and health security archetypes, although there was a range of performance within each archetype. Considering common barriers and facilitators of decision-making and implementation of adult vaccines within a primary archetype could help provide a framework for strategies to support countries with similar needs and approaches. It can also help in developing context-specific policies and guidance, including for countries prioritizing adult immunization programs in light of COVID-19. Further research may be beneficial to further refine archetypes and expand the understanding of what influences success within them. This can help advance policies and action that will improve vaccine access for older adults and build a stronger appreciation of the value of immunization amongst a variety of stakeholders.     

Two decades of vaccine innovations for global public good: Report of the Developing Countries’ Vaccine Manufacturers Network 20th meeting, 21–23 october 2019, Rio de Janeiro,Brazil

The Developing Countries’ Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health organizations reviewed efforts to accelerate innovation, improve access to vaccines, overcome inequalities and strengthen technological and public-health management capabilities. Discussion topics included World Health Organization’s immunization strategy, Pan American Health Organization’s system-strengthening efforts, Gavi’s evaluation of vaccine coverage in middle income countries and developments on public-market intelligence. Health market trends, delivery gaps, integration of system-wide needs, costs and benefits, and implications for stakeholder decision-making were areas of focus. Novel thinking was discussed on integration of policy, financing, regulatory pathways and alignment of innovation priorities to improve efficiency in vaccine development pathways. The Vaccine Innovation Prioritization Strategy collaboration presented nine global innovation priorities, and many other partners and members presented updates on their priorities. Novel technologies and platforms, such as RNA-based vaccines, adenoviral vectors, bioconjugation, blow-fill-seal and two-dimensional barcodes, provided opportunities to accelerate vaccine innovations. Challenges in planning and operations at global level included those in health security, polio eradication, re-emergence of diseases, disparities between forecasts and orders and heterogeneous regulatory requirements. Manufacturers were urged to accelerate innovation and prequalification of high-impact vaccines, such as pneumococcal, human papillomavirus and rotavirus vaccines, to strengthen immunization globally.