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Pathways to economically viable and sustainable vaccine manufacturing in LMICs. 在中低收入国家实现经济上可行和可持续的疫苗生产的途径。
IF 3.5 Pub Date : 2026-02-14 DOI: 10.1016/j.vaccine.2026.128273
Matthias Helble, Claudia Nannei, Martin Friede, Martin W Nicholson

In an effort to improve pandemic preparedness and health security, many low- and middle-income countries (LMICs) have launched initiatives to expand regional vaccine manufacturing. A number of elements relating to vaccine markets, production, value chains, and ecosystems significantly impact the ability to generate economically viable and sustainable vaccine manufacturing in LMICs. This paper provides an overview of vaccine manufacturing characteristics and global vaccine markets dynamics. Establishing vaccine manufacturing is a complex undertaking due to a variety of factors including intense competition, associated uncertainty regarding the ability to capture market share and substantial capital investment requirements. Substantive government commitment and investment are essential to ensure new local entrants compete successfully. In the medium to long run, the role of government should shift from supporting individual firms to strengthening local science ecosystems as this bolsters economic sustainability in three ways. First, investment in science promotes technological advances which can reduce production costs, e.g., through process innovations for vaccine manufacturing. Second, strong science ecosystems help to address the skills gap faced by manufacturers. And third, strong science ecosystems enable research and development of new vaccines that address local unmet needs and open new markets. Furthermore, developing a regional approach to vaccine manufacturing and procurement, with associated regulatory harmonization, is crucial to achieving economically viable and distributed vaccine manufacturing. Importantly, investment in research and development and fostering of regional collaborations drives innovation, feeding into new product discovery and consequently a strong pipeline of new vaccine products, driving economically sustainable regional vaccine manufacturing. This offers the potential to prevent endemic infectious diseases with significant socioeconomic and health burden or to develop therapeutic vaccines, generating regular interpandemic demand for regional vaccine manufacturers, consequently sustaining capacity retention and associated pandemic preparedness.

为了改善大流行防范和卫生安全,许多低收入和中等收入国家发起了扩大区域疫苗生产的举措。与疫苗市场、生产、价值链和生态系统有关的一些因素对中低收入国家开展经济上可行和可持续的疫苗生产的能力产生重大影响。本文概述了疫苗生产特点和全球疫苗市场动态。由于各种因素,包括激烈的竞争、获取市场份额能力的相关不确定性以及大量资本投资需求,建立疫苗生产是一项复杂的工作。实质性的政府承诺和投资对于确保新的本地进入者成功竞争至关重要。从中长期来看,政府的角色应该从支持个体企业转变为加强地方科学生态系统,因为这可以从三个方面促进经济的可持续性。首先,对科学的投资促进技术进步,从而降低生产成本,例如通过疫苗生产工艺创新。其次,强大的科学生态系统有助于解决制造商面临的技能差距。第三,强大的科学生态系统使研究和开发新疫苗能够解决当地未满足的需求并打开新市场。此外,制定疫苗生产和采购的区域办法以及相关的监管协调,对于实现经济上可行和分散的疫苗生产至关重要。重要的是,对研发的投资和促进区域合作推动创新,促进新产品的发现,从而形成强大的新疫苗产品管道,推动经济上可持续的区域疫苗生产。这提供了预防具有重大社会经济和健康负担的地方性传染病或开发治疗性疫苗的潜力,从而对区域疫苗制造商产生定期的大流行间需求,从而维持能力保持和相关的大流行防范。
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引用次数: 0
The evolving landscape of RSV immunization: Current policies and practices across Europe. RSV免疫的发展前景:整个欧洲当前的政策和做法。
IF 3.5 Pub Date : 2026-02-13 DOI: 10.1016/j.vaccine.2026.128222
Zazie Franck, Sanne Hofstraat, Lotte Jonker, Leyla Kragten, Chiara Messina, Ricardo M Fernandes, Patricia Bruijning-Verhagen

Background: Following approval of the first Maternal RSV vaccine (MV) and long-acting monoclonal RSV antibody (la-mAbs) in Europe, several countries have begun integrating the products into their infant RSV immunization programs.

Methods: Based on a survey supplemented by policy documents, this paper provides a descriptive, policy-focused cross-sectional overview of RSV immunization strategies across 32 European countries.

Results: As of September 2025, 22 countries offered programmatic RSV prophylaxis for infants. Of these, 5 use only MV, 10 use only la-mAbs and 7 countries offer both. Considerable variation was observed in programmatic approaches with respect to (gestational) age of administration, delivery pathways, eligibility criteria for mothers and infants, and reimbursement mechanisms.

Conclusions: The RSV immunization policy landscape in Europe is diverse and dynamic, presenting both challenges and opportunities for shared learning and policy development.

背景:在欧洲批准首个母体RSV疫苗(MV)和长效RSV单克隆抗体(la- mab)后,一些国家已开始将这些产品纳入其婴儿RSV免疫计划。方法:基于一项辅以政策文件的调查,本文对32个欧洲国家的RSV免疫策略进行了描述性的、以政策为重点的横断面概述。结果:截至2025年9月,22个国家为婴儿提供了程序化的RSV预防。其中,5个国家仅使用MV, 10个国家仅使用la- mab, 7个国家同时提供两种抗体。在给药(胎龄)、分娩途径、母亲和婴儿的资格标准以及报销机制方面,方案方法存在相当大的差异。结论:欧洲RSV免疫政策格局是多样化和动态的,为共同学习和政策制定提供了挑战和机遇。
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引用次数: 0
Population effects of influenza vaccination in children and adolescents: Systematic review. 儿童和青少年接种流感疫苗的人群效应:系统评价。
IF 3.5 Pub Date : 2026-01-25 Epub Date: 2025-12-07 DOI: 10.1016/j.vaccine.2025.128040
Mona Askar, Karam Adel, Madeleine Batke, Yuan Chi, Lea Gorenflo, Anna Hayman Robertson, Kari Johansen, Jorgen de Jonge, Philipp Kapp, Tyra Grove Krause, Elizabeth Lynch, Joerg J Meerpohl, Angeliki Melidou, Hanna Nohynek, Carmen Olmedo, Kate Olsson, Ioanna Pavlopoulou, Jaime Jesús Pérez, Vanessa Piechotta, Catalina Hamon Pinilla, Johanna Rubin, Veronika Učakar, Julia Wilhelm, Ole Wichmann, Thomas Harder

Objectives: To investigate indirect vaccine effectiveness (indirVE) of vaccination of children and adolescents with seasonal influenza vaccines against influenza-related outcomes occurring in other population groups.

Methods: We performed a systematic review of studies (randomized and non-randomized) on indirVE of vaccination of participants aged 6 months-17 years with tri- or quadrivalent seasonal influenza vaccines against influenza (lab-confirmed; non-lab-confirmed) occurring in contacts of vaccinated persons or members of the wider community (last search: 17th March 2024). GRADE certainty of evidence (CoE) was evaluated (PROSPERO: CRD42024546400).

Results: We identified 28 studies (5 randomized; 23 non-randomized). In community-based studies, indirect protection against laboratory-confirmed influenza (LCI) ranged from -38 % [95 % CI: -574 to 72] to 61 % [95 % CI: 8-83] (very low CoE). In household-based settings, indirVE against LCI varied between -151.2 % [95 % CI: -1194.6 to 51.3] and 39.4 % [95 % CI: 7.4 to 60.3] (very low CoE). In school-based settings, highly variable indirect effects were observed on LCI, hospitalization, emergency department visits and school/work absenteeism (very low CoE).

Conclusions: There is no clear evidence of indirect effects from influenza vaccination in children. While plausible, effect size is uncertain and varies by study design, population, and vaccine type. Stronger indirect effects appeared only when direct VE was high.

目的:调查儿童和青少年接种季节性流感疫苗对其他人群发生的流感相关结局的间接疫苗有效性(indive)。方法:我们对6个月至17岁的参与者接种三价或四价季节性流感疫苗的研究(随机和非随机)进行了系统回顾,以预防在接种疫苗者或更广泛社区成员的接触者中发生的流感(实验室确诊;非实验室确诊)(最后检索:2024年3月17日)。评估证据的等级确定性(CoE) (PROSPERO: CRD42024546400)。结果:我们确定了28项研究(5项随机,23项非随机)。在以社区为基础的研究中,针对实验室确诊流感的间接保护(LCI)范围从- 38% [95% CI: -574 - 72]到61% [95% CI: 8-83](非常低的CoE)。在以家庭为基础的环境中,对LCI的影响在- 151.2% [95% CI: -1194.6至51.3]和39.4% [95% CI: 7.4至60.3](非常低的CoE)之间变化。在以学校为基础的环境中,在LCI、住院、急诊科就诊和学校/工作缺勤(非常低的CoE)方面观察到高度可变的间接影响。结论:没有明确的证据表明儿童接种流感疫苗有间接影响。虽然看似合理,但效应大小是不确定的,并因研究设计、人群和疫苗类型而异。只有当直接VE高时,才会出现更强的间接效应。
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引用次数: 0
Adjuvanted recombinant zoster vaccine and live attenuated zoster vaccine are vastly different. 佐剂重组带状疱疹疫苗和减毒带状疱疹活疫苗有很大的不同。
IF 3.5 Pub Date : 2026-01-23 DOI: 10.1016/j.vaccine.2026.128272
Emily Jane Woo
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引用次数: 0
Response to Anticipated impact of novel adult-specific pneumococcal conjugate vaccine by Joshi et al. Joshi等人对新型成人特异性肺炎球菌结合疫苗预期影响的反应。
IF 3.5 Pub Date : 2025-11-15 DOI: 10.1016/j.vaccine.2025.127988
J M McLaughlin, J Wassil
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引用次数: 0
Value profile for Malaria vaccines and monoclonal antibodies. 疟疾疫苗和单克隆抗体的价值概况。
IF 3.5 Pub Date : 2025-11-15 DOI: 10.1016/j.vaccine.2025.127971
Ashley J Birkett, Evelyn Ansah, Scott Gordon, Margaret Gyapong, Shanelle Hall, Sherrie L Kelly, Matthew Laurens, Melissa A Penny, Meredith Shirey, Laurence Slutsker, Erin Sparrow, Sally Ethelston, Nelli Westercamp, Lindsey Wu, Mary J Hamel

Malaria remains a leading cause of morbidity and mortality and is responsible for over 0.5 million annual deaths globally. During the first two decades of this century, scale-up of a range of tools was associated with significant reductions in malaria mortality in the primary risk group, young African children. However, in recent years progress has stalled and even reversed in some high-burden countries, highlighting the urgent need for new interventions. Since 2021, two malaria vaccines have received World Health Organization (WHO) recommendations and Gavi, the Vaccine Alliance financing and are now in high demand across sub-Saharan Africa. Despite their promise, including a 13 % decline in all-cause mortality and a 22 % drop in severe malaria hospitalizations following pilot introduction, there remains keen interest in developing improved vaccines in alignment with WHO's preferred product characteristics (PPCs), revised in 2022 (see https://www.who.int/publications/i/item/9789240057463). Further, monoclonal antibody (mAb) prophylaxis has emerged as a promising new intervention, which led to WHO's developing a new guidance document to inform PPCs for malaria mAbs (see https://www.who.int/publications/i/item/9789240070981). The priority focus for these aspirational tools is on prevention of disease and death in young African children; however, there is increasing focus on tools that could be deployed across entire populations to break the cycle of parasite transmission and accelerate elimination. Further, accelerated impact of next-generation vaccines is emerging thanks to the pioneering introduction of current vaccines into established national immunization programs and strong coordination with national malaria programs. This vaccine value profile (VVP) for malaria-developed by a working group of subject matter experts from academia, nonprofit and multilateral organizations, and public-private partnerships-provides a high-level, holistic assessment of current, existing information and data that are publicly available to inform the potential public health, economic, and societal value of vaccines and prophylactic mAbs in the development pipeline.

疟疾仍然是发病和死亡的主要原因,每年在全球造成50多万人死亡。在本世纪头二十年,一系列工具的推广与主要风险群体非洲幼儿疟疾死亡率的显著降低有关。然而,近年来,在一些高负担国家,进展停滞甚至逆转,这突出表明迫切需要采取新的干预措施。自2021年以来,两种疟疾疫苗得到了世界卫生组织(世卫组织)的建议和疫苗联盟全球疫苗免疫联盟的资助,目前在撒哈拉以南非洲各地需求量很大。尽管这些疫苗带来了希望,包括在试点后全因死亡率下降13%,严重疟疾住院率下降22%,但人们仍然对根据世卫组织2022年修订的首选产品特性(PPCs)开发改进疫苗抱有浓厚兴趣(见https://www.who.int/publications/i/item/9789240057463)。此外,单克隆抗体(mAb)预防已成为一种有希望的新干预措施,这促使世卫组织制定了一份新的指导文件,为PPCs提供疟疾单克隆抗体(见https://www.who.int/publications/i/item/9789240070981)。这些理想工具的优先重点是预防非洲幼儿的疾病和死亡;然而,人们越来越关注可以在整个种群中部署的工具,以打破寄生虫传播的循环并加速消除。此外,由于开创性地将现有疫苗引入已建立的国家免疫规划,并与国家疟疾规划进行强有力的协调,下一代疫苗的影响正在加速显现。疟疾疫苗价值概况(VVP)由来自学术界、非营利组织和多边组织以及公私合作伙伴关系的主题专家组成的工作组制定,提供了对公开可用的当前、现有信息和数据的高层次、全面评估,以告知正在开发中的疫苗和预防性单克隆抗体的潜在公共卫生、经济和社会价值。
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引用次数: 0
Corrigendum to "COVID-19 vaccine attitudes, beliefs, intentions and behaviors among pregnant women within the context of dynamic national policy recommendations in Brazil, Ghana, Kenya, and Pakistan" [Vaccine (2025) 127595]. “巴西、加纳、肯尼亚和巴基斯坦动态国家政策建议背景下孕妇对COVID-19疫苗的态度、信念、意图和行为”[疫苗(2025)127595]的勘误表。
IF 3.5 Pub Date : 2025-09-25 DOI: 10.1016/j.vaccine.2025.127768
Jessica L Schue, Emily S Miller, Berhaun Fesshaye, Prachi Singh, Renato T Souza, Caroline Dinam Badzi, Emefa Modey Amoah, Saleem Jessani, Muhammad Asim, Ingrid Gichere, Maria Laura Costa, Jose G Cecatti, Kwasi Torpey, Sarah Saleem, Marleen Temmerman, Sami L Gottlieb, Rupali J Limaye
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引用次数: 0
Increase of Haemophilus influenzae type b meningitis, beyond initial findings. b型流感嗜血杆菌脑膜炎增加,超出最初的发现。
IF 3.5 Pub Date : 2025-09-20 DOI: 10.1016/j.vaccine.2025.127764
Corinne Levy, Emmanuelle Varon, Stéphane Béchet, Stéphane Bonacorsi, Robert Cohen
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引用次数: 0
Examining the role of influence and trust in information sources on the COVID-19 vaccine decision-making process for pregnant and postpartum women in Brazil, Ghana, Kenya, and Pakistan: A mixed methods study. 研究巴西、加纳、肯尼亚和巴基斯坦孕妇和产后妇女对信息来源的影响和信任在COVID-19疫苗决策过程中的作用:一项混合方法研究
IF 3.5 Pub Date : 2025-09-12 DOI: 10.1016/j.vaccine.2025.127721
Jessica L Schue, Berhaun Fesshaye, Emily S Miller, Prachi Singh, Ruth A Karron, Saleem Jessani, Muhammad Asim, Ferdinand Okwaro, Caroline Dinam Badzi, Emefa Modey Amoah, Renato T Souza, Maria Laura Costa, Marleen Temmerman, Kwasi Torpey, Jose G Cecatti, Sarah Saleem, Grace Belayneh, Vanessa Brizuela, Sami L Gottlieb, Rupali J Limaye

Introduction: This study examined associations between information sources and COVID-19 vaccination behavior among pregnant and postpartum women in Brazil, Ghana, Kenya, and Pakistan.

Methods: This mixed methods study involved concurrent in-depth interviews and cross-sectional surveys.

Results: A total of 1797 women participated in the study. Overall, participants were more likely to be vaccinated if they believed that they knew enough about safety to make a decision (aOR: 1.51; CI: 1.04-2.20) and trusted the information they received from healthcare providers (aoR: 1.74; CI: 1.19-2.54). Odds of vaccination were higher among those who trusted information provided by scientists (aoR:1.86; CI: 1.31-2.63) and among those who believed that leaders in their community recommended the COVID-19 vaccine (aOR: 1.4; CI: 1.01-1.92). Higher odds of vaccination were observed among participants in Pakistan who had the information they needed to make a decision (aOR: 2.58; CI: 1.35-4.94), knew enough about safety to make a decision (aOR: 3.82; CI: 1.85-7.89), trusted the information they received from healthcare providers (aOR: 3.20; CI: 1.39-7.34), and believed that community leaders recommended the COVID-19 vaccine (aOR: 2.53; CI: 1.22-5.25). Participants in Brazil who trusted information provided by scientists (aOR: 4.70; CI: 1.23-18.05); participants in Kenya who trusted information from the media (aOR: 1.94; CI: 1.10-3.44); and participants in Ghana who trusted recommendations from their government (aOR: 2.66; CI: 1.42-5.0) had higher odds of vaccination. Interviewed women noted that they felt overwhelmed with the amount of information and misinformation related to COVID-19 and the vaccine specifically.

Discussion: Trusted COVID-19 vaccine information sources reported by pregnant and postpartum women vary by country, suggesting the need to identify sources across different target populations to improve vaccine acceptability and uptake with the goal of realizing the population level benefits of vaccination.

本研究调查了巴西、加纳、肯尼亚和巴基斯坦孕妇和产后妇女中信息来源与COVID-19疫苗接种行为之间的关系。方法:采用深度访谈和横断面调查相结合的方法进行研究。结果:共有1797名女性参与了这项研究。总的来说,如果参与者相信他们对安全有足够的了解来做出决定(aOR: 1.51; CI: 1.04-2.20),并且相信他们从医疗保健提供者那里得到的信息(aOR: 1.74; CI: 1.19-2.54),那么他们更有可能接种疫苗。那些相信科学家提供的信息的人(aoR:1.86; CI: 1.31-2.63)和那些相信社区领导推荐的COVID-19疫苗的人(aoR: 1.4; CI: 1.01-1.92)接种疫苗的几率更高。在拥有决策所需信息(aOR: 2.58; CI: 1.35-4.94)、对安全性有足够了解以做出决策(aOR: 3.82; CI: 1.85-7.89)、信任医疗保健提供者提供的信息(aOR: 3.20; CI: 1.39-7.34)并相信社区领导人推荐的COVID-19疫苗(aOR: 2.53; CI: 1.22-5.25)的巴基斯坦参与者中观察到更高的疫苗接种几率。巴西的参与者相信科学家提供的信息(aOR: 4.70; CI: 1.23-18.05);肯尼亚的参与者相信来自媒体的信息(aOR: 1.94; CI: 1.10-3.44);在加纳,相信政府建议的参与者(aOR: 2.66; CI: 1.42-5.0)接种疫苗的几率更高。受访女性指出,与COVID-19特别是疫苗有关的大量信息和错误信息让她们感到不堪重负。讨论:各国孕妇和产后妇女报告的可信COVID-19疫苗信息来源各不相同,这表明需要确定不同目标人群的信息来源,以提高疫苗的可接受性和吸收率,从而实现接种疫苗在人群层面的益处。
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引用次数: 0
Myths, mandates, and decision-making: A qualitative exploration of COVID-19 vaccine hesitancy among pregnant and postpartum women in Pakistan. 误解、授权和决策:巴基斯坦孕妇和产后妇女COVID-19疫苗犹豫的定性探索
IF 3.5 Pub Date : 2025-09-09 DOI: 10.1016/j.vaccine.2025.127722
Muhammad Asim, Saleem Jessani, Sarah Saleem, Haleema Yasmeen, Sidrah Nausheen, Jessica L Schue, Prachi Singh, Berhaun Fesshaye, Vanessa Brizuela, Rupali J Limaye

Background: Among pregnant and postpartum women, decision-making for receiving the COVID-19 vaccine is influenced by vaccine safety concerns, misconceptions, shifting vaccine policies, and exclusion in the initial vaccine rollout. This caused confusion and vaccine hesitancy among many groups including pregnant and postpartum women.

Objective: The objective of this study was to understand the multilevel factors that influence vaccine decision-making among pregnant and postpartum women in Pakistan, which is crucial for improving vaccine demand among the vulnerable group-pregnant and postpartum women.

Methods: This study is part of a multi-country mixed method study conducted in Brazil, Ghana, Kenya, and Pakistan. In Pakistan, fifty in-depth interviews were conducted with pregnant and postpartum women from two hospitals in Karachi. A grounded theory analysis approach was used, and a socio-ecological framework encompassing four levels of influence was applied to synthesize the study findings.

Results: At the individual level, influences included concerns about vaccine safety, particularly regarding the health of the women and their babies due to potential side effects. Strong religious beliefs and trust in God also deterred some women from receiving the COVID-19 vaccine, as they relied on their faith practices. However, women with confidence in the vaccine had a positive attitude toward vaccination. At the interpersonal level, factors influencing vaccine decisions included the strong influence of observing others and recommendations from family and healthcare providers. Community-level factors included misconceptions about the vaccine's purpose and effects, and religious leaders' recommendations either supporting or discouraging vaccination. Policy-level factors involved mandatory vaccination for accessing public spaces, employment, and healthcare services. Coercive vaccination policies led some women to obtain vaccine cards without getting vaccinated.

Conclusions: Efforts to promote vaccination among pregnant and postpartum women in Pakistan should engage family members, healthcare providers, and religious leaders, and implement evidence-based vaccine mandates to increase demand and to support uptake of maternal COVID-19 vaccination.

背景:在孕妇和产后妇女中,接种COVID-19疫苗的决策受到疫苗安全问题、误解、疫苗政策转变以及最初疫苗推广中的排斥等因素的影响。这在包括孕妇和产后妇女在内的许多群体中造成了混乱和疫苗犹豫。目的:了解影响巴基斯坦孕妇和产后妇女疫苗接种决策的多层面因素,对改善弱势群体孕妇和产后妇女的疫苗需求具有重要意义。方法:本研究是在巴西、加纳、肯尼亚和巴基斯坦进行的多国混合方法研究的一部分。在巴基斯坦,对卡拉奇两家医院的孕妇和产后妇女进行了50次深入访谈。采用扎根理论分析方法,并采用包含四个影响水平的社会生态框架来综合研究结果。结果:在个人层面上,影响包括对疫苗安全性的担忧,特别是由于潜在的副作用而对妇女及其婴儿的健康的担忧。强烈的宗教信仰和对上帝的信任也阻止了一些妇女接种COVID-19疫苗,因为她们依靠自己的信仰实践。然而,对疫苗有信心的妇女对疫苗接种持积极态度。在人际层面上,影响疫苗决策的因素包括观察他人的强烈影响以及来自家庭和卫生保健提供者的建议。社区层面的因素包括对疫苗目的和效果的误解,以及宗教领袖支持或反对接种疫苗的建议。政策层面的因素涉及进入公共场所、就业和医疗保健服务的强制性疫苗接种。强制性疫苗接种政策导致一些妇女在没有接种疫苗的情况下获得了疫苗卡。结论:在巴基斯坦促进孕妇和产后妇女接种疫苗的工作应让家庭成员、医疗保健提供者和宗教领袖参与进来,并实施基于证据的疫苗授权,以增加需求并支持孕产妇接种COVID-19疫苗。
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引用次数: 0
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Vaccine
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