Country experiences of introducing PCV into NIP

Country experiences of introducing PCV into NIP

A study conducted jointly by Gavi and Johns Hopkins University reviewed the status of 39 countries that had not yet introduced the pneumococcal conjugate vaccine (PCV) into their National Immunization Programs (NIPs) by the end of 2021. Among them, there were 33 lower-middle-income countries and 6 high-income countries.

The study identified ten indicators affecting the policy decision of introducing PCV, including the incidence of pneumonia, under-five mortality rates, health expenditure as a percentage of GDP, coverage rates of diphtheria-tetanus-pertussis (DTP) vaccine in 2021, coverage rates of the first dose of measles vaccine, the introduction of other new vaccines (including rotavirus vaccine, human papillomavirus vaccine, inactivated poliovirus vaccine, or the second dose of meningococcal vaccine), the status of PCV introduction, the establishment of National Immunization Technical Advisory Group (NITAG), political will for PCV introduction, and eligibility for Gavi support. The study assessed the policy barriers faced by 33 LMICs in the process of introducing PCV.1

Among all 33 countries, 15 countries faced low policy barriers, with 12 countries having  moderate policy barriers (including China in this category) and 6 countries facing high policy barriers. The study considered two major obstacles to the introduction of PCV were conflicts with national priorities and the vaccine price.

Among the 18 countries facing moderate to high barriers, 15 (83%) were middle-income countries, which are generally slower in introducing new vaccines (such as PCV) due to the lack of external support (i.e. Gavi), lighter disease burdens, or cost barriers of the vaccine price. Compared to low-income countries, middle-income countries actually have a larger susceptible population. Especially in countries facing moderate barriers, the challenges in introducing PCV are diverse. For instance, Egypt has a well-established immunization system but cannot introduce PCV immediately due to competition with other national priorities. China, despite having domestically produced PCV vaccines, still faces difficulties in rapid introduction due to the lack of Gavi support, slow lot release processes, and other logistical factors.1

Venezuela—was among the earliest to introduce new vaccines into national immunization programs (NIPs), particularly rotavirus vaccines and PCV vaccines. A systematic review has analyzed the key factors in the decision-making process for introducing PCV into the immunization schedules of these countries, which included the availability of adequate funding (e.g., national fiscal funds and external financial support from international organizations), sufficient scientific evidence supporting the introduction, and the feasibility of long-term sustainable vaccine financing.2

In these five countries, the introduction of new vaccines initially driven by a political commitment, which were subsequently supported by technical inputs. The procurement of vaccines through donations, Gavi, or national fiscal funding was crucial. In countries implementing the expanded immunization programs (EPI), having legal frameworks related to immunization is a key element to support the introduction of new vaccines and ensures the program’s sustainability. Prior to the new vaccine introduction, these countries generally lacked surveillance data and local disease burden data. However, disease monitoring, as well as the assessment of implementation, was initiated during or after the new vaccine introduction.2

The Pan American Health Organization (PAHO) published a report in 2012 that summarized the experiences of different countries in the region regarding the introduction of PCVs into the NIPs, focusing on four aspects: the decision-making process, the formulation of immunization protocols, the calculation of annual dosage requirements, and the transition between different PCV vaccines (Table 1).

Table 1: Lesson learned from the introduction of PCV vaccine in Latin America and the Caribbean

No.Decision-making for introduction of PCVSelection of the vaccination scheduleCalculation of the number of doses for the year of introductionInterchangeability
1Produce and identify relevant objective evidence of the impact of vaccination on the disease in the country. Ideally, this evidence should be supported by national data.***Coordination with the national regulatory authority beforehand is necessary to ensure that the registration of the vaccine and the vaccination schedule are in line with the recommendations of other supranational committees. ***The calculation of the number of vaccines needed should consider the vaccination schedule, 100% of the target cohorts, and the vaccination policy in the year the vaccine is introduced. ***Evidence must be generated to support decisions on exchanging one vaccine presentation for another.***
2Design a planning document for the introduction of PCV to ensure sustainable introduction of the vaccine and measurement of the impact of vaccination. ***In Caribbean countries, special innovative agreements should be fostered between the public and private sectors to facilitate adherence to the schedule selected.***Cold chain capacity must be adapted to the vaccination schedule, to the number of doses planned for introduction of the vaccine and to future demand. ***The decision to change the type of vaccine used should be discussed and taken jointly by all of the components of the immunization program and the advisory committee. ***
3Foster and advocate the introduction of PCV in order to have a political environment that facilitates the availability of resources to make introduction of the vaccine sustainable. ***Having epidemiological data on the distribution of the disease makes it possible to identify the vaccination schedule for PCV which is best suited to the country’s needs. **Plan for availability of a stock of at least 25% of the annual requirement for the vaccine for the year it is introduced. **The document on the scheduling of vaccine interchangeability should keep the transition period and vaccine loss to a minimum.  ***
4Monitoring and integrated analysis of information should be performed by every component of the immunization program in planning for introduction of the vaccine.**Timely access to recommendations from international reference sources facilitates selection of the best vaccination schedule for PCV. **It must be decided whether to vaccinate only those who turn a certain age or all of those who are of the ages of the cohorts scheduled for vaccination. **The information system should be enhanced in order to identify the cohorts 11 vaccinated by type of vaccine.  ***
5The existence of a legal framework on vaccines facilitates their introduction and ensures the sustainability of PCV in the immunization program. **When a PCV is introduced into the national vaccination schedule, it is recommendable to take advantage of vaccination opportunities already established by each country’s schedule. **Ideally, the vaccine should be introduced at the beginning of the year. *For Caribbean countries, establishing channels of communication with the private sector in charge of vaccination is critical for the purchase and provision of vaccines. In addition, communication among countries in the area is important for coordinating a joint approach.  ***
6The purchase of vaccines through the PAHO Revolving Fund lends feasibility and sustainability to the introduction of PCV. **Establish standardized technical guidelines and disseminate them to different target audiences. **Train the different levels of the immunization program extensively and effectively on the process of introducing a new type of vaccine.**
7National immunization advisory committees, committees on immunization practices or however whatever they are called in each country, should be technically sound and independent. **
Priority Level: *Desirable, **Important, ***Indispensable
 
PAHO/WHO (Pan American Health Organization / World Health Organization). Lessons Learned from the Introduction of the Pneumococcal Conjugate Vaccine (PCV) in Latin America and the Caribbean. Washington, DC: PAHO/WHO; March 2012. https://www3.paho.org/hq/dmdocuments/2012/PCV-LessonsLearned-Americas-Oct2012.pdf

A study conducted in Chad, Guinea, Somalia/Somaliland, and South Sudan analyzed the key elements and factors for the sustainable implementation of the rapid introduction of PCV in resource-scarce and fragile regions.3 These factors include shared responsibility between national leaders and external partners, effective inter-sectoral collaboration, strengthening of national surveillance systems, and improvements in health infrastructure and management capabilities.

Country case study

1. Indonesia

Since 2017, the Clinton Health Access Initiative (CHAI) and partners have provided evidence-based decision-making and implementation support to the Indonesian government, assisting in the integration of PCV into the routine immunization schedule. Therefore, Indonesia accelerated the rollout of PCV, achieving nationwide coverage by 2022. During the introduction of PCV, Indonesia faced three main challenges: decision-making and immunization financing related to vaccine procurement and delivery, limitations of the existing vaccine procurement and distribution systems, and insufficient confidence among policymakers regarding the feasibility and sustainability of PCV introduction.4

To address these challenges, Indonesia undertook the following preparatory work: 1) Collaboration between third-party research institutions and multiple national departments (such as statistics and health insurance departments) to collect high-quality evidence on disease burden and costs, confirming a high cost-effectiveness ratio for PCV introduction; 2) Financial impact assessments for PCV introduction, establishing multi-source mechanisms to ensure sustainable financing; 3) Strengthened cross-sectoral collaboration; 4) applying for Gavi’s Advance Market Commitment program and procuring PCV vaccines at 16% of market price, reducing vaccine procurement costs; 5) Implementing local pilot programs and summarizing key lessons learned before scaling up nationally; 6) After regional pilot success, conducting preparation and risk assessment for nationwide rollout, and developing risk management strategies.5

2. Bangladesh6

A Comprehensive assessment of the readiness of medical institutions to provide services helps identify obstacles in the implementation of immunization programs, as well as providing evidence and references for improved decision-making and rational allocation of resources. Bangladesh introduced PCV in 2015 and in 2018 used the World Health Organization’s Service Availability and Readiness Assessment (SARA) tool to evaluate the readiness of health care facilities in two regions on their medical service provision, including specific services (childhood immunization services). The study showed that Bangladesh had a high immunization coverage rate (84%), with overall sufficient PCV supply, and the introduction of PCV into the national immunization program largely depended on whether healthcare facilities were able and ready to deliver immunization services.

In the same study, 59 institutions providing childhood immunization services in two regions of Bangladesh were included. Institutions with vaccine storage capacity had better readiness (including vaccine accessibility, storage capacity, personnel training, funding, etc.), while those without storage capacity needed to improve their service readiness. Among the 59 institutions, only nine had vaccine storage capacity, using a combination of ice-lined refrigerators and power supply to maintain vaccine storage temperature (i.e., 2-8°C). In institutions without storage capacity, although disposable syringes were available, only a few had corresponding instruments and consumables. None of the tertiary hospitals, private clinics, or pharmacies in the surveyed areas functioned as vaccination centers, and 53 (89.83%) vaccination centers were in rural areas. Regarding training, all 59 childhood immunization service institutions had received formal training for PCV immunization. However, 54 (91.52%) reported a lack of sufficient funding and vaccine resources for training programs.6

3. Peru2

Peru enacted the Vaccine Law in 1993, which clearly stipulates that the government provides financial support for most immunization activities. Before the introduction of PCV, Peru lacked nationwide data on the burden of pneumococcal disease, but regional data indicated a concerning disease burden, which became the basis for further decision-making on vaccine introduction. Additionally, a study commissioned by the Ministry of Health in 2008 showed that pneumonia was the second leading cause of healthy life years lost in Peru.

In 2008, with the support of the Comité Consultivo (similar to the National Immunization Technical Advisory Group, NITAG), the Minister of Health decided to include rotavirus vaccine (RV), influenza vaccine, and PCV in the national expanded immunization program, purchasing RV and PCV vaccines through PAHO’s revolving funds. However, several challenges were encountered during implementation, including the lack of a specific social mobilization plan, insufficient training before vaccine introduction, limited cold chain capacity, etc. Moreover, due to age-specific vaccination regulations (e.g., PCV primary immunization was set at three and five months instead of two and four months), leading to missed vaccinations among eligible children due to narrow age eligibility criteria.


Content Editor: Menglu Jiang, Ziqi Liu

Page Editor: Ziqi Liu


References

  1. Banerjee, P., Huber, J., Denti, V., Sauer, M., Weeks, R., Dhaliwal, B. K., & Shet, A. (2023). Closing the pneumococcal conjugate vaccine (PCV) introduction gap: an archetype analysis of last-mile countries. Global health action, 16(1), 2281065. https://doi.org/10.1080/16549716.2023.2281065
  2. de Oliveira, L. H., Toscano, C. M., Sanwogou, N. J., Ruiz-Matus, C., Tambini, G., Roses-Periago, M., & Andrus, J. K. (2013). Systematic documentation of new vaccine introduction in selected countries of the Latin American Region. Vaccine, 31 Suppl 3, C114–C122. https://doi.org/10.1016/j.vaccine.2013.05.032
  3. Dhaliwal, B. K., Weeks, R., Huber, J., Fofana, A., Bobe, M., Mbailamen, A. D., … & Shet, A. (2024). Introduction of the pneumococcal conjugate vaccine in humanitarian and fragile contexts: Perspectives from stakeholders in four African countries. Human Vaccines & Immunotherapeutics, 20(1), 2314828.
  4. Athiyaman, A., Herliana, P., Anartati, A. et al. Accelerating Pneumococcal Conjugate Vaccine introductions in Indonesia: key learnings from 2017 to 2022. Infect Dis Poverty 12, 107 (2023). https://doi.org/10.1186/s40249-023-01161-5
  5. Increase in coverage of key non-immunization program vaccines in China | Innovation Lab for Vaccine Delivery Research | Duke Kunshan University. (n.d.). https://vaxlab.dukekunshan.edu.cn/en/paper/issue-iii-overall-increase-in-coverage-of-key-non-immunization-program-vaccines-in-china/ 
  6. Shawon MSR, Adhikary G, Ali MW, et al. General service and child immunization-specific readiness assessment of healthcare facilities in two selected divisions in Bangladesh. BMC Health Serv Res. 2018 25;18(1):39.

代表性地区的基本情况、接种政策及效果、宣传推动情况

(1) 成都市

 

基本情况

成都市2022年度GDP为20817.5亿元,排名全国城市第七。成都市出台了《健康城市建设推动健康中国行动创新模式成都市宫颈癌综合防控试点工作方案》等一系列相关政策推动适龄女孩HPV疫苗接种工作。

接种政策及效果

目标人群为13-14岁在校且无HPV疫苗接种史女生。免疫程序为国产二价0-6二剂次、进口二价0-1-6三剂次、进口四价0-2-6三剂次。资助政策为国产二价疫苗(沃泽惠)免费,其它疫苗补贴600元/人,并自付20元/剂接种费。疫苗接种按照属地化管理原则,由学校所在地预防接种单位负责。截至2022年1月,目标人群首针接种率达90.04%[14]。

宣传推动

成都市开展多形式、多载体的健康教育宣传。形式包括讲座、知晓日、义诊咨询、专题课程、专题活动等,载体包括宣传册、宣传栏、展板、电视、微信、视频号、抖音平台等,覆盖相关医疗机构300余、社区300余个、和公众场所90余个。面向适龄女孩及监护人、适龄女性及全体市民开展广泛宣教,宣传材料发放至近9万名群众,讲座活动覆盖近2万名群众。宣教内容包括HPV疫苗接种、两癌防控、其它女性常见疾病防控等。

(2) 济南市

 

基本情况

济南市2022年度GDP为12027.5亿元,位列全国城市排名20。2021年,济南市出台《健康城市建设推动健康中国行动创新模式试点一济南市宫颈癌综合防治工作方案(2021—2025年)》等一系列相关政策推动适龄女孩HPV疫苗接种工作。

接种政策及效果

目标人群为≤14周岁且无HPV疫苗接种史的在校七年级女生。免疫程序为国产二价0-6二剂次。资助政策免费接种。疫苗接种按照属地化管理原则,安排分班级分时段前往学校所在地的预防接种单位进行接种。截至2022年11月,目标人群首针接种率达
94.4%[15].

宣传推动

济南市开展多形式、多载体的健康教育宣传。形式包括采访、线上线下专题活动,载体包括网络媒体、纸媒、科普展板、宣传手册、子宫颈癌与HPV疫苗知识读本、济南HPV疫苗接种手册,宣教人群广泛涵盖全体市民,宣教内容包括HPV疫苗接种、两癌防控等知识。

(3) 鄂尔多斯市

 

基本情况

鄂尔多斯市2022年度GDP为5613.44亿元,全国地级市第45位。2021年,鄂尔多斯市出台了《健康城市建设推动健康鄂尔多斯行动创新模式工作方案》等一系列相关政策推动适龄女孩HPV疫苗接种工作。

接种政策及效果

2020年8月,鄂尔多斯市在准格尔旗率先开展HPV疫苗免费接种项目。目标人群为全市当年13-18岁在校且无HPV疫苗接种史女生。免疫程序为进口二价0-1-6三剂次,

2023年起调整为13-14岁女孩0-6二剂次。资助政策为疫苗免费,自付20元/剂接种费。组织方式为疫苗接种服务中心根据任务安排联系学校,有规划的通知适龄女孩前来完成HPV疫苗接种。截至2022年11月,目标人群首针接种率接近70%[16]。

2022年8月,启动准格尔旗和达拉特旗高三女生接种四价和九价HPV疫苗的试点工作,利用暑假时间展开接种,力争在2023年年底达成90%的接种目标[17]。自鄂尔多斯之后,由政府主导的HPV疫苗惠民行动在多地等涌现。值得注意的是,近年来多主体参与到HPV疫苗支持项目,如慈善总会、医院、妇联等为主体单位牵头组织开展了一些公益活动。

宣传推动

鄂尔多斯市开展多形式、多载体的健康教育宣传。形式包括讲座、知晓日、义诊咨询、专题课程、专题活动等,载体包括宣传册、宣传栏、展板、电视、微信、视频号、抖音平台等,宣教人群广泛涵盖在校女孩及监护人,适龄女性及全体市民。宣教内容包括HPV疫苗接种、两癌防控、其它女性常见疾病防控等。

(4) 西安市

 

基本情况

西安市2022年度GDP为11486.51亿元,排名全国第22位。2021年,西安市出台了《西安市健康城市建设推动健康中国行动创新模式试点宫颈癌综合防治工作方案》等一系列相关政策推动适龄女孩HPV疫苗接种工作。

接种政策及效果

目标人群为全市年龄满13周岁(初中)在校女生。免疫程序为国产二价0-6二剂次,进口二价0-1-6三剂次,进口四价和进口九价0-2-6三剂次。接种政策为自愿自费。各区(县)合理设立HPV疫苗专项疫苗接种门诊承担接种任务,并及时将接种信息统一录入儿童免疫规划信息平台。

宣传推动

西安市出台了《西安市宫颈癌综合防治宣传方案》(市健办发〔2022〕12号)。通过媒体宣传、社区活动、义诊等形式,宣传册、宣传栏、展板、电视、微信公众号、报纸等载体普及宫颈癌防治相关知识。

(5) 西藏自治区

 

基本情况

西藏自治区2022年度GDP为2132.64亿元,经济总量整体规模相对其他省份较小,人均GDP处于全国中等偏下水平。2022年出台《西藏自治区妇女“两癌”综合防治工作实施方案》等系列政策推动适龄女孩HPV疫苗接种。

接种政策及效果

目标人群为13-14岁在校女生。免疫程序为国产二价0-6二剂次。资助政策为免费。由学校组织,接种者在商定接种时间携带个人身份证明材料与法定监护人一同前往定点接种单位接种。

宣传推动

充分利用网络、电视、广播、报刊等媒介,以群众喜闻乐见的宣传方式,对适龄在校女生HPV疫苗接种工作的意义及内容进行广泛宣传。

近年来各地HPV疫苗惠民项目信息

“疾病负担”指标解读

疾病负担(burden of disease, BOD)是指疾病造成的失能(伤残)、生活质量下降和过早死亡对健康和社会造成的总损失,包括疾病的流行病学负担和经济负担两个方面。

 

在疾病的流行病学方面,衡量疾病负担的常用指标包括传统指标和综合指标。

 

传统指标

传统疾病负担的衡量指标包括:用于描述和反映健康状况与水平的常规指标,如死亡人数、伤残人数和患病人数等绝对数指标;以及用来比较不同特征人群疾病分布差异的指标,如发病率、伤残率、患病率、死亡率、门诊和住院率等相对数指标。

 

上述传统疾病负担的衡量指标基本上只考虑了人口的生存数量,而忽略了生存质量,不够全面;但优势在于资料相对计算方便,结果直观,可用于各种疾病的一般性描述。

 

综合指标

疾病负担不等同于死亡人数,综合指标弥补了传统指标的单一性,且可以让各种不同疾病造成的负担之间相互比较。

 

潜在寿命损失年(YPLL):通过疾病造成的寿命损失来估计疾病负担的大小。但忽略了疾病造成的失能对生存质量的影响。

 

伤残调整寿命年(DALYs):将死亡和失能相结合,用一个指标来描述疾病的这两方面的负担。它包括因早死造成健康生命年的损失(YLL)和因伤残造成健康生命年的损失(YLD),即DALY=YLL+YLD。目前,DALY是国内外一致公认的最具代表性、运用最多的疾病负担评价指标。

 

健康期望寿命(HALE):指具有良好健康状态的生命年以及个体在比较舒适的状态下生活的平均预期时间,综合考虑生命的质量和数量两方面。

 

 

随着疾病负担研究的深入,其测量范围从流行病学负担扩大到经济负担。

 

疾病经济负担是由于发病、伤残(失能)和过早死亡给患者本人、家庭以及社会带来的经济损失,和由于预防治疗疾病所消耗的经济资源。

详细见:疾病的“经济负担”怎么计算?

 

参考资料:

陈文. 卫生经济学 [M]. 人民卫生出版社. 2017.

李茜瑶,周莹,黄辉等.疾病负担研究进展[J].中国公共卫生,2018,34(05):777-780.

什么是“年龄标化”?

在流行病学研究中,年龄是多种疾病的危险因素。以发病率为例,该指标反映了一定时期内,特定人群中癌症新发病例的情况。由于年龄是癌症发生的一个重要影响因素,年龄越大,发病率就越高。

 

如果两个国家的人群年龄结构相差很大,例如A市老年人口比例更大,B市年轻人口占比更高,直接比较两地癌症发病率的高低,我们不能确定发病率较高的市,是因为年龄构成不同还是因为其他影响因素(如饮食习惯、环境等)所导致。因此,需要用“年龄标化”的统计学方法,进一步处理数据,排除年龄影响因素的干扰,再来比较两地的发病率数据。

 

以发病率为例,即把原始数据套到一个“标准年龄结构人群里”,计算出”年龄标化发病率“,这样人群结构不同的A市和B市,就能在同一个指标尺度下进行“发病率”比较。年龄标化通常有“中标率”,即我国各地基于某一年份的中国人口年龄结构构成作为标准计算,国内不同地区的疾病数据比较采用的是“中标率”;另一种是“世标率”,即用世界标准人口构成机型标化计算,适用于国与国之间的指标比较。

 

同样地,以死亡率为例,应特别注意各之间地人口构成的差异。用标准化死亡率进行比较才能得出正确结论。如甲、乙两地在未标化前的肺癌死亡率相同,但实际上乙地人群的肺癌死亡率要明显地高于甲地,其原因在于甲地男性老年人口居多,而肺癌的死亡率又与年龄和性别有关,所以用未标化率进行比较时,就会得出甲乙两地肺癌死亡率相同的错误结论。

 

参考资料:

 

张科宏教授:年龄标化的患病率 – 丁香公开课 (dxy.cn)

科学网—癌症(粗)发病率与标化发病率的区别 – 杨雷的博文 (sciencenet.cn)

WHO年龄标化死亡率定义及计算方法

沈洪兵,齐秀英. 流行病学 [M]. 人民卫生出版社. 2015.

疾病的“经济负担”怎么计算?

疾病经济负担是由于发病、伤残(失能)和过早死亡给患者本人、家庭以及社会带来的经济损失,和由于预防治疗疾病的费用。通过计算疾病的经济负担,可以从经济层面上研究或比较不同疾病对人群健康的影响。

总疾病经济负担包括直接疾病经济负担、间接疾病经济负担和无形疾病经济负担。

直接经济负担:指直接用于预防和治疗疾病的总费用,包括直接医疗经济负担和直接非医疗经济负担两部分。直接医疗经济负担是指在医药保健部门购买卫生服务的花费,主要包括门诊费(如挂号费、检查费、处置费、诊断费、急救费等)、住院费(如手术费、治疗费等)和药费等。直接非医疗经济负担包括和疾病有关的营养费、交通费、住宿费、膳食费、陪护费和财产损失等。

间接经济负担:指由于发病、伤残(失能)和过早死亡给患者本人和社会带来的有效劳动力损失而导致的经济损失。具体包括:劳动工作时间损失、个人工作能力和效率降低造成的损失、陪护病人时损失的劳动工作时间、精神损失等。

无形经济负担:指患者及亲友因疾病在心理、精神和生活上遭受的痛苦、悲哀、不便等生活质量下降而产生的无形损失。

 

参考资料:

陈文. 卫生经济学 [M]. 人民卫生出版社. 2017.

李茜瑶,周莹,黄辉等.疾病负担研究进展[J].中国公共卫生,2018,34(05):777-780.