Issue 100 | WHO issued global market landscape of vaccine manufacturing and procurement report; Expert consensus on the implementation and evaluation process of free influenza vaccination project for students in China

Journal Articles Recommendation

01

Global market landscape of vaccine manufacturing and procurement

On December 16, 2025, the World Health Organization (WHO) released the report Global Vaccine Manufacturing and Procurement Market Landscape. Drawing on 2023 data from 204 countries and 98 vaccine manufacturers, the report presents a comprehensive picture of the global vaccine ecosystem from both the demand side (countries) and the supply side (manufacturers), helping global, regional, and national stakeholders understand the current distribution of vaccine manufacturing and procurement across markets, technologies, and regions.

Key findings show that all WHO regions are interdependent for vaccine supply. At the country level, no nation meets its vaccine needs solely through production within its own region; countries in all regions procure vaccines whose production stages span multiple regions. In the WHO African Region, fewer than 5% of vaccines are supplied by companies headquartered in the region, reflecting a heavy reliance on manufacturers based in the WHO South-East Asia Region. By contrast, the South-East Asia Region is the most self-sufficient, sourcing 89% of vaccines from within the region, followed by the Western Pacific (67%) and European Regions (54%).

The report notes that domestic manufacturing capacity can strengthen national supply security, and regional manufacturing can be an important source for countries within a region. However, having domestic production does not guarantee supply security during emergencies. Vaccine production is typically concentrated within a single region across all stages, indicating manufacturers’ preference for vertically integrated, single-site operations. High-income countries (HICs) tend to procure vaccines from manufacturers headquartered in HICs, while low-income countries (LICs) rely on manufacturers based in HICs and middle-income countries (MICs). When supply is constrained, prioritization of higher-profit markets may pose access risks for LICs.

Vaccine manufacturing is highly skewed: a small number of large companies sell more than 400 million doses with revenues exceeding USD 5 billion, while 75–85% of manufacturers are small or medium-sized. Production capacity for innovative vaccines—such as mRNA and viral-vector vaccines—remains concentrated in a few countries with advanced biomanufacturing capabilities, with technology transfer and localized production still at an early stage.

The report concludes that achieving equitable access to vaccines requires strengthening regional manufacturing capacity, optimizing market structures, and overcoming technical and regulatory barriers. Continued global monitoring of regional manufacturing capacity is essential to inform decisions toward a more resilient, equitable, and sustainable global vaccine system.

Original Report: https://www.who.int/publications/i/item/9789240118249

02

​​Expert consensus on the implementation and evaluation process of free influenza vaccination project for students

This article was published in the Chinese Journal of Preventive Medicine and developed by the Expert Group on the Implementation and Evaluation of the Free Influenza Vaccination Program for Students. The consensus addresses the importance and feasibility of implementing free influenza vaccination programs for students, as well as program organization and implementation, supervision and management, and outcome evaluation. Nine key questions were systematically identified, and the GRADE approach was used to assess the quality of evidence and strength of recommendations. Taking into account China’s national context and practical experience, a total of 13 recommendations were formulated to provide scientific and actionable policy guidance for health authorities, CDCs, medical institutions, community health service centers, and schools that have implemented or plan to implement such programs.

The consensus highlights that primary and secondary school students are a key population for influenza transmission. Implementing free vaccination programs for students has significant public health value in reducing influenza-related disease and economic burden. Experts recommend setting a target influenza vaccination coverage of 70% among primary and secondary school students, to be achieved through policy support, centralized vaccination, and strengthened health education.

Regarding program organization and implementation, the consensus recommends assessing funding sources, vaccine supply security, vaccination service capacity, and parental acceptance during the planning stage. A multi-sectoral coordination mechanism led by health authorities, CDCs, and education departments should be established, with clear roles and standardized procedures for vaccine procurement, storage, distribution, and informed consent. Vaccination should begin at least one month before the local influenza season, and vaccine type and formulation should be selected based on epidemiological characteristics, budget, and vaccine availability. Health education is identified as a key strategy to improve coverage and should target students, parents, and teachers, covering influenza epidemiology, clinical manifestations, benefits of vaccination, precautions, and adverse reactions, using both traditional and new media channels.

For supervision and evaluation, the consensus recommends that CDCs, together with health and education departments, conduct full-process oversight of program planning, implementation, and completion in accordance with regulations. Feasibility and social risk assessments should be conducted when programs are first introduced or when major changes are made. Program evaluation should cover vaccination coverage, vaccine effectiveness, safety, satisfaction, health economics, and health benefits. Program reports should include implementation and evaluation findings, methods, outcomes, recommendations for future actions, and supporting documentation.

Overall, this consensus establishes a systematic and standardized framework for the implementation and evaluation of free influenza vaccination programs for students, providing an important foundation for the institutionalized and evidence-based advancement of influenza prevention and control in schools in China.

DOI:10.3760/cma.j.cn112150-20250210-00096

03

Immunogenicity and safety of inactivated quadrivalent influenza vaccines in children aged 6–35 months: A multi-center, randomized, double-blind, active-controlled clinical trial

This study was published in Vaccine. It aimed to systematically evaluate the immunogenicity and safety of full-dose and half-dose quadrivalent inactivated influenza vaccines (QIV) in children aged 6–35 months, compared with licensed half-dose trivalent inactivated influenza vaccines (TIV). A multicenter, randomized, double-blind, active-controlled phase III clinical trial was conducted in Hubei and Anhui provinces. Eligible healthy children aged 6–35 months were randomized in a 2:2:1:1 ratio to receive full-dose QIV, half-dose QIV, half-dose TIV containing the B/Victoria lineage, or half-dose TIV containing the B/Yamagata lineage, administered as a two-dose regimen at days 0 and 28.

Blood samples were collected before vaccination and 28 days after the second dose to measure hemagglutination inhibition (HI) antibody responses. The primary endpoints were seroconversion rates (SCRs) and geometric mean titers (GMTs) 28 days after the second dose. Non-inferiority was defined as a lower bound of the 95% confidence interval of the SCR difference of no less than −10% and a lower bound of the 95% confidence interval of the GMT ratio of no less than 2/3. Safety was monitored for six months after the final vaccination.

Between September 16 and October 13, 2023, a total of 3,468 children were screened, and 3,300 were enrolled, of whom 3,289 received at least one dose. Immunogenicity analyses showed that both full-dose and half-dose QIV were non-inferior to half-dose TIV for all shared strains in terms of SCRs and GMTs. Notably, full-dose QIV induced significantly higher immune responses than half-dose QIV and half-dose TIV. Safety profiles were comparable across groups, and no vaccine-related serious adverse events or febrile seizures were observed.

In conclusion, both full-dose and half-dose QIV demonstrated immunogenicity non-inferior to licensed half-dose TIV in children aged 6–35 months. Importantly, full-dose QIV elicited stronger immune responses without new safety concerns, suggesting the potential to provide enhanced protection for this age group.

https://doi.org/10.1016/j.vaccine.2025.128113

04

Informing the development of transmission modelling guidance for global immunization decision-making: A qualitative needs assessment

This study was published in Vaccine and aimed to inform the development of World Health Organization (WHO) guidance on mathematical modeling to support global immunization policy decisions through a qualitative needs assessment. The objective was to clarify end users’ specific needs regarding both the content and format of such guidance. In-depth interviews were conducted with 15 immunization decision-makers and mathematical modeling experts from all six WHO regions, representing high-, middle-, and low-income countries. Interviews focused on: (1) understanding and use of modeling evidence; (2) challenges in applying modeling evidence; and (3) types of guidance that could facilitate effective use of modeling evidence.

The study found that participants with modeling expertise were able to apply modeling evidence directly and systematically, often serving as consultants to support decision-making. In contrast, less experienced users—typically policy advisors—reported low confidence in interpreting models, with some avoiding modeling evidence altogether. Decision-makers without modeling backgrounds expressed a need for more information to understand the value of models in specific contexts, although most acknowledged their potential usefulness. All participants agreed on the importance of capacity building and localization of modeling evidence to enhance trust, with less experienced users emphasizing the need for ongoing engagement with knowledge brokers and targeted training.

Multiple challenges to the use of modeling evidence were identified. At the decision-making level, limited meeting time (e.g., model briefings restricted to 20 minutes) and insufficient understanding of complex modeling processes and inherent uncertainties were major barriers. Participants from some low- and middle-income countries highlighted additional constraints, including limited local data, inadequate technical resources, and delayed access to non-English technical materials. Concerns were also raised about the transferability of models across contexts; for example, COVID-19 models based on epidemiological parameters from high-income countries could produce substantial bias when applied in low-income settings, leading some decision-makers to rely more heavily on recommendations from authoritative bodies such as WHO rather than on models themselves.

Based on these findings, the study recommends developing user-friendly guidance with clear navigation to help decision-makers assess model quality, understand added value, and integrate modeling evidence into localized decision processes. Participants also emphasized that combining online training with practice-oriented communities of practice could substantially improve understanding, confidence, and effective use of modeling evidence. Insights from this study have been incorporated into the development of relevant WHO guidance.

https://doi.org/10.1016/j.vaccine.2025.126800

05

Vaccine Hesitancy and Immunization Patterns in Central and Eastern Europe: Sociocultural, Economic, Political, and Digital Influences Across Seven Countries

This study was published in Risk Management and Healthcare Policy and applied qualitative comparative analysis to examine national policy documents, vaccination coverage data, determinants of vaccine hesitancy, and stakeholder perspectives across seven Central and Eastern European countries (Hungary, Slovakia, Romania, Czech Republic, Poland, Ukraine, and Lithuania). The study aimed to identify the underlying sociocultural, economic-political, and digital factors shaping vaccine hesitancy and immunization patterns in the region, thereby informing the optimization of regional immunization strategies.

The findings revealed substantial cross-country variation and temporal dynamics in vaccination coverage. Hungary and the Czech Republic maintained near-universal coverage within routine immunization programs, whereas measles–mumps–rubella (MMR) coverage in Slovakia, Romania, and Poland fell below the WHO-recommended 95% herd immunity threshold, contributing to recurrent measles outbreaks. Influenza vaccination coverage rose briefly during the early COVID-19 period but subsequently declined across countries; Slovakia reported coverage below 5%, among the lowest in the EU, alongside persistently low acceptance of COVID-19 vaccines. In Poland, the number of officially registered vaccine refusals more than doubled between 2017 and 2022, with the strongest resistance observed for MMR vaccination. In contrast, Lithuania achieved notable increases in influenza and pneumococcal vaccine coverage through integrated measures such as vaccination certificates and strengthened public health communication. These differences were driven by interacting factors including health system structures, public trust in institutions, exposure to misinformation, and the effectiveness of digital communication strategies.

Based on these findings, the study recommends a comprehensive approach to improving vaccination uptake in Central and Eastern Europe. Key measures include strengthening digital and mobile health infrastructure to improve access for rural and socioeconomically disadvantaged populations; enhancing digital health literacy, particularly among younger and marginalized groups, to counter online misinformation; implementing culturally adapted, value-oriented communication strategies aligned with local religious and social norms; and providing healthcare workers with training in empathetic counseling and motivational interviewing. In addition, the authors emphasize the importance of real-time monitoring systems integrating digital surveillance and social sentiment analysis, enhanced cross-border and intersectoral collaboration, and inclusive governance mechanisms that actively engage community leaders, educators, and patient organizations.

The study concludes that cross-border cooperation and context-specific public health communication tailored to cultural and socioeconomic conditions are critical for strengthening regional immunization resilience and achieving the elimination of vaccine-preventable diseases.

https://doi.org/10.2147/RMHP.S519479

06

Effectiveness of a targeted infant RSV immunization strategy (2024–2025): A multicenter matched case-control study in a high-surveillance setting

This study was published in the Journal of Infection. It aimed to evaluate the real-world effectiveness of the long-acting monoclonal antibody nirsevimab in preventing respiratory syncytial virus (RSV)–associated hospitalizations among infants younger than 12 months within a seasonal immunization program.

A prospective, multicenter, matched case–control design was used across seven hospitals in Italy during the 2024–2025 RSV season. Infants hospitalized with PCR-confirmed RSV bronchiolitis (cases) were matched 1:2 by age and admission date to infants hospitalized for non-respiratory conditions (controls). A total of 138 infants were included, comprising 46 RSV cases and 92 controls.

After adjustment for potential confounders such as sex and gestational age, the estimated effectiveness of nirsevimab against RSV-related hospitalization was 89.5% (95% CI: 60.3%–97.2%). Stratified analyses showed consistent protection across subgroups, with an effectiveness of 88.4% (95% CI: 56.5%–96.9%) among infants born after April 1, and 88.1% (95% CI: 45.7%–97.4%) among infants without clinical risk factors. Sensitivity analysis using inverse probability of treatment weighting confirmed a significant protective effect (effectiveness 79.6%, 95% CI: 53.5%–91.0%). In addition, none of the immunized infants required intensive care, and oxygen requirements were significantly reduced.

The study provides robust real-world evidence supporting the high effectiveness of nirsevimab within a targeted seasonal immunization strategy, offering critical empirical support for the phased implementation of RSV prevention policies across diverse healthcare settings.

https://doi.org/10.1016/j.jinf.2025.106600


Content Editor: Tianyi Deng

Page Editor: Ruitong Li

Others

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.