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Post-emergency use authorization active safety surveillance study of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine in the Veterans Affairs health system: Findings from a three-year, comprehensive safety assessment program 退伍军人事务卫生系统中辉瑞- biontech 2019冠状病毒病(COVID-19)疫苗紧急后使用授权主动安全监测研究:一项为期三年的综合安全评估项目的结果
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-25 DOI: 10.1016/j.jvacx.2026.100791
Kofi Asomaning , Mei Sheng Duh , Maral DerSarkissian , Cynthia de Luise , Catherine Nguyen , Mu Cheng , Angela Lax , Tracy Guo , Marianne Cunnington , Pierre Cremieux , Yinong Young-Xu , Caroline Korves , Jurandir Dalle Lucca

Background

This non-interventional, active safety surveillance study conducted signal detection/evaluation analyses for the primary series, monovalent booster doses, and Omicron BA.4/BA.5-adapted bivalent booster dose of the Pfizer-BioNTech COVID-19 vaccine among Veterans Health Administration (VHA) enrollees.

Methods

Repeated longitudinal, cohort study analyses using data from the VHA Corporate Data Warehouse were conducted. Among individuals who received ≥1 Pfizer-BioNTech COVID-19 vaccination between 12/11/2020–06/30/2023, an active comparator design was used to monitor the occurrence of 48 safety events of interest in this population compared to individuals with seasonal influenza vaccines during the 2014/2015–2018/2019 influenza seasons. In addition, a self-controlled risk interval design was used to compare the occurrence of safety events of interest during post-vaccination risk versus control intervals among individuals experiencing the safety event of interest.

Results

The Pfizer-BioNTech COVID-19 vaccine sample comprised 1,652,514 individuals, the majority of whom were male (89.8%) with an average age of 64.0 years (median = 67.4); it included 59.7% White non-Hispanic and 22.0% Black individuals. The seasonal influenza vaccine sample included 4,104,220 individuals, and baseline demographic and clinical characteristics were generally similar between the Pfizer-BioNTech COVID-19 and seasonal influenza vaccine samples (standardized differences <10%). After signal detection analyses, further investigation was warranted for cerebrovascular non hemorrhagic stroke, other acute demyelinating disease, Guillain-Barré syndrome, anaphylaxis, acute myocardial infarction, arrhythmia, coronary artery disease, myocarditis, stress cardiomyopathy, microangiopathy, chilblain-like lesions, hemorrhagic disease, pulmonary embolism, optic neuritis, heart failure and cardiogenic shock, acute kidney injury, deep vein thrombosis, and severe COVID-19 disease. However, no safety events remained after signal evaluation analysis (including for myocarditis/pericarditis), regardless of the vaccine dose.

Conclusions

There was no increased risk of any of the 48 safety events of interest evaluated following Pfizer-BioNTech COVID-19 vaccination in the VHA population.
这项非干预性、主动安全性监测研究对初级系列、单价加强剂量和Omicron BA.4/BA进行了信号检测/评价分析。在退伍军人健康管理局(VHA)注册者中,辉瑞- biontech COVID-19疫苗的5适应双价加强剂量。方法利用VHA企业数据仓库的数据进行重复纵向、队列研究分析。在2020年11月12日至2023年6月30日期间接种≥1次辉瑞- biontech COVID-19疫苗的个体中,采用主动比较设计监测该人群在2014/2015-2018/2019流感季节期间与接种季节性流感疫苗的个体相比发生的48个安全事件。此外,一个自我控制的风险区间设计被用来比较疫苗接种后安全事件的发生风险与经历安全事件的个体的控制区间。结果辉瑞- biontech COVID-19疫苗样本包括1,652,514例,其中大多数为男性(89.8%),平均年龄为64.0岁(中位数= 67.4);其中包括59.7%的非西班牙裔白人和22.0%的黑人。季节性流感疫苗样本包括4,104,220人,辉瑞- biontech COVID-19和季节性流感疫苗样本的基线人口统计学和临床特征大致相似(标准化差异<;10%)。在信号检测分析后,对脑血管非出血性中风、其他急性脱髓鞘疾病、格林-巴勒综合征、过敏反应、急性心肌梗死、心律失常、冠状动脉疾病、心肌炎、应激性心肌病、微血管病变、冻疮样病变、出血性疾病、肺栓塞、视神经炎、心力衰竭和心源性休克、急性肾损伤、深静脉血栓形成、重症COVID-19疾病进行进一步调查。然而,无论疫苗剂量如何,经过信号评估分析(包括心肌炎/心包炎)后,没有安全事件存在。结论:在VHA人群中接种辉瑞- biontech COVID-19疫苗后,48项相关安全事件的风险均未增加。
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引用次数: 0
Cost-effectiveness analysis of 20-valent pneumococcal conjugate vaccine in the Portuguese paediatric national immunisation programme 葡萄牙儿童国家免疫规划中20价肺炎球菌结合疫苗的成本效益分析
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-24 DOI: 10.1016/j.jvacx.2026.100789
Cátia Mota , An Ta , Elizabeth Vinand , Rita Teixeira , Aleksandar Ilic , Sophie Warren

Background

Since the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) for paediatric use in Portugal, pneumococcal disease incidence among children has declined. With the availability of 20-valent PCV (PCV20) and 15-valent PCV (PCV15) and the Portuguese Board of Health's decision to implement PCV20 2 + 1 into the National Immunisation Programme (NIP), the cost-effectiveness of PCV20 under 2 + 1 and 3 + 1 schedules was assessed versus PCV13 2 + 1 and PCV15 2 + 1 in Portugal.

Methods

Using a Portuguese National Health Service (NHS) perspective, a Markov model with annual cycles estimated health and cost impacts of PCV20 versus PCV13 and PCV15 over 10 years, with both cost and benefits discounted at 4%. Direct effects were based on PCV13 effectiveness and 7-valent PCV efficacy studies; indirect effects were sourced from PCV13 impact studies. Epidemiologic, utility, and cost inputs were from Portuguese data, where available. Sensitivity and scenario analyses tested result robustness.

Results

The base case showed that PCV20 2 + 1 was dominant versus both PCV13 and PCV15. PCV20 2 + 1 was estimated to avert 1884 invasive pneumococcal disease (IPD) cases, 54,768 hospitalised pneumonia cases, 222,497 otitis media (OM) cases, and 8737 deaths versus PCV13 2 + 1, resulting in a quality-adjusted life year (QALY) gain of 109,092 and cost-saving of €237,294,966. PCV20 2 + 1 averted 1653 IPD cases, 42,182 hospitalised pneumonia cases, 202,735 OM cases, and 6594 deaths versus PCV15 2 + 1, resulting in a QALY gain of 83,799 and cost-saving of €199,695,659. Pairwise comparisons of PCV20 3 + 1 versus PCV13 2 + 1 and PCV15 2 + 1, including sensitivity and scenario analyses, consistently showed cost-saving results, aligning with findings from PCV20 2 + 1 analysis.

Conclusions

PCV20 (both 2 + 1 and 3 + 1) was estimated to be cost saving and more effective versus PCV13 and PCV15. Switching from PCV13 to PCV20 in the Portuguese paediatric NIP could yield considerable clinical and economic benefits from NHS perspective.
背景:自从葡萄牙引入13价肺炎球菌结合疫苗(PCV13)用于儿科使用以来,儿童肺炎球菌疾病的发病率已经下降。随着20价PCV (PCV20)和15价PCV (PCV15)的可用性以及葡萄牙卫生委员会决定将PCV20 2 + 1纳入国家免疫规划(NIP),在葡萄牙评估了PCV20在2 + 1和3 + 1计划下与PCV13 2 + 1和PCV15 2 + 1的成本效益。方法采用葡萄牙国家卫生服务体系(NHS)的视角,采用具有年周期的马尔可夫模型估计PCV20与PCV13和PCV15在10年内对健康和成本的影响,成本和收益均折扣率为4%。直接效应基于PCV13和7价PCV的有效性研究;间接影响来源于PCV13影响研究。在可用的情况下,流行病学、效用和成本输入来自葡萄牙的数据。敏感性和情景分析检验了结果的稳健性。结果基础病例显示PCV20 2 + 1对PCV13和PCV15均具有优势。与PCV13 2 + 1相比,PCV20 2 + 1估计可避免1884例侵袭性肺炎球菌病(IPD)病例,54,768例住院肺炎病例,222,497例中耳炎(OM)病例,8737例死亡,导致质量调整生命年(QALY)增加109,092,节省成本237,294,966欧元。与PCV15 2 + 1相比,PCV20 2 + 1避免了1653例IPD病例、42,182例住院肺炎病例、202,735例OM病例和6594例死亡,导致质量效益增加83,799例,节省成本199,695,659欧元。PCV20 3 + 1与PCV13 2 + 1和PCV15 2 + 1的两两比较,包括敏感性和情景分析,一致显示成本节约的结果,与PCV20 2 + 1分析的结果一致。结论与PCV13和PCV15相比,spcv20(2 + 1和3 + 1)可节省成本,且更有效。从NHS的角度来看,葡萄牙儿科NIP从PCV13切换到PCV20可以产生可观的临床和经济效益。
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引用次数: 0
Identifying factors associated with acceptance of the fourth COVID-19 vaccine dose: A multicentre cross-sectional study in Indonesia 确定与接受第四剂COVID-19疫苗相关的因素:印度尼西亚的一项多中心横断面研究
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.jvacx.2026.100784
Muh. Akbar Bahar , Abd. Rafik Mohi , Ikhwan Yuda Kusuma , Dezső Csupor , Muh. Nasrum Massi

Background

Although the World Health Organization declared the end of COVID-19 as a global health emergency in May 2023, COVID-19 remains a public health concern due to continued transmission, variants, and waning immunity. However, the number of individuals who have received a complete series of COVID-19 vaccinations in developing countries, such as Indonesia, is still limited.

Objective

This study aimed to explore the factors influencing the acceptance of the fourth dose of the COVID-19 vaccine in Indonesia.

Methods

A multicentre cross-sectional study using an online questionnaire was conducted from June to September 2023 among the Indonesian population aged 18 years and older. The validated self-administered questionnaire consists of three parts: sociodemographic variables, clinical history, and domains of the Health Belief Model (perceived severity, perceived susceptibility, perceived clinical barriers, perceived barriers to access to booster vaccination and perceived benefits of booster vaccine). Multivariate logistic regression was employed to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for independent variables associated with acceptance of the fourth dose of the COVID-19 vaccine.

Results

Of 1850 eligible participants, only 11% had received the fourth dose of the COVID-19 vaccine. The independent determinants of the acceptance of the fourth dose of the COVID-19 vaccine were as follows: age groups 26–35 years (OR: 1.73, 95%CI: 1.00–3.01), 36–45 years (OR: 2.65, 95%CI: 1.35–5.21), and over 45 years (OR: 3.68, 95%CI: 2.05–6.63); working as a healthcare worker (OR: 2.03, 95%CI: 1.11–3.69); having a chronic disease (OR: 1.71, 95%CI: 1.07–2.73); history of COVID-19 infection (OR: 1.64, 95%CI: 1.12–2.41); perceived susceptibility to COVID-19 (OR: 1.31, 95%CI: 1.09–1.57); and perceived benefits of the booster vaccine (OR: 1.27, 95%CI: 1.04–1.56).

Conclusion

The acceptance of the fourth COVID-19 vaccine booster in Indonesia remained low, despite substantial evidence demonstrating its effectiveness and safety, particularly in protecting vulnerable populations. Vaccine coverage could be improved by campaigns based on key determinants of acceptance such as age, chronic disease, COVID-19 infection history and perceptions of vulnerability to infection and benefits of the vaccine.
尽管世界卫生组织于2023年5月宣布COVID-19作为全球突发卫生事件结束,但由于持续传播、变异和免疫力下降,COVID-19仍然是一个公共卫生问题。然而,在印度尼西亚等发展中国家,接种了全套COVID-19疫苗的人数仍然有限。目的探讨影响印尼新冠肺炎第四剂疫苗接受度的因素。方法于2023年6月至9月对印尼18岁及以上人群采用在线问卷进行多中心横断面研究。经验证的自我管理问卷由三部分组成:社会人口学变量、临床病史和健康信念模型的领域(感知严重性、感知易感性、感知临床障碍、感知获得加强疫苗的障碍和感知加强疫苗的益处)。采用多因素logistic回归来估计与第四剂COVID-19疫苗接受度相关的自变量的调整优势比(ORs)和95%置信区间(CIs)。在1850名符合条件的参与者中,只有11%的人接种了第四剂COVID-19疫苗。接受第四剂COVID-19疫苗的独立决定因素如下:26-35岁(OR: 1.73, 95%CI: 1.00-3.01)、36-45岁(OR: 2.65, 95%CI: 1.35-5.21)和45岁以上(OR: 3.68, 95%CI: 2.05-6.63);从事卫生保健工作(OR: 2.03, 95%CI: 1.11-3.69);患有慢性疾病(OR: 1.71, 95%CI: 1.07-2.73);COVID-19感染史(OR: 1.64, 95%CI: 1.12-2.41);感知COVID-19易感性(OR: 1.31, 95%CI: 1.09-1.57);增强疫苗的预期获益(OR: 1.27, 95%CI: 1.04-1.56)。结论尽管有大量证据表明第四种COVID-19疫苗增强剂的有效性和安全性,特别是在保护弱势人群方面,但印度尼西亚对该疫苗的接受程度仍然很低。可以根据年龄、慢性病、COVID-19感染史以及对感染易感性和疫苗益处的认识等决定接受程度的关键因素开展运动,提高疫苗覆盖率。
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引用次数: 0
Barriers and facilitators to pneumococcal vaccination in rural community pharmacy: A qualitative study 农村社区药房肺炎球菌疫苗接种的障碍和促进因素:一项定性研究
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.jvacx.2026.100786
Leticia E.B. Vieira , Grace T. Marley , Tessa J. Hastings , Salisa C. Westrick , Ashley H. Chinchilla , Tyler C. Melton , Delesha M. Carpenter

Background

Inadequate pneumococcal vaccine uptake in rural U.S. communities remains a significant barrier to effective pneumococcal disease prevention. Community pharmacists are well-positioned to expand vaccine coverage by offering and administering pneumococcal vaccines, but face unique challenges in rural pharmacy settings.

Objective

To explore pharmacist-reported barriers and facilitators to pneumococcal vaccination in rural community pharmacies.

Methods

Qualitative interviews were conducted with twenty rural pharmacists from a practice-based research network (a collaborative group of community pharmacies engaged in applied research to improve pharmacy practice) across seven U.S. states. Pharmacists were purposefully sampled based on their state and the number of pneumococcal vaccines administered at their pharmacy in the previous year. Interviews assessed factors influencing pneumococcal vaccination across levels of the Social Ecological Framework. Interviews continued until thematic saturation was reached, and iterative thematic analysis of de-identified interview transcripts was conducted until no new themes emerged.

Results

Barriers and facilitators to pneumococcal vaccination were identified across all socioecological levels. At the individual level, themes included pharmacists' attitudes, training, and rapport with patients, as well as patients' attitudes, knowledge, and out-of-pocket costs. At the organizational level, themes were related to the pharmacy workflow, staff, time constraints, immunization area, and vaccine stocking costs. Community-level themes involved local physicians, social influences, and factors specific to rural areas. Policy-level themes encompassed vaccination guidelines, states' immunization registries, reimbursement, and immunization regulations.

Conclusion

Pneumococcal vaccination in rural community pharmacies is influenced by multilevel factors, including individual, organizational, community, and policy factors. Effective interventions will require training initiatives for pharmacists, resources to improve patients' vaccine knowledge and attitudes, organizational strategies to streamline immunization workflow, and policy changes to advance pharmacy-based immunization services that account for rural community needs.
背景:在美国农村社区,肺炎球菌疫苗接种不足仍然是有效预防肺炎球菌疾病的一个重要障碍。社区药剂师处于有利地位,可以通过提供和管理肺炎球菌疫苗来扩大疫苗覆盖面,但在农村药房环境中面临独特的挑战。目的探讨药师报告的农村社区药房肺炎球菌疫苗接种的障碍和促进因素。方法对美国七个州的20名农村药剂师进行了定性访谈,这些药剂师来自一个基于实践的研究网络(一个从事应用研究以改善药房实践的社区药房合作小组)。有针对性地根据药剂师的状态和上一年在其药房接种肺炎球菌疫苗的数量对其进行抽样。访谈评估了影响社会生态框架各层次肺炎球菌疫苗接种的因素。采访继续进行,直到主题饱和,对去识别的采访记录进行反复的主题分析,直到没有新的主题出现。结果在所有社会生态水平上都确定了肺炎球菌疫苗接种的障碍和促进因素。在个人层面上,主题包括药剂师的态度、培训、与患者的关系,以及患者的态度、知识和自付费用。在组织层面,主题涉及药房工作流程、工作人员、时间限制、免疫领域和疫苗储存成本。社区层面的主题涉及当地医生、社会影响和农村地区特有的因素。政策层面的主题包括疫苗接种指南、各州免疫登记、报销和免疫条例。结论农村社区药房肺炎球菌疫苗接种受个人、组织、社区和政策等多方面因素的影响。有效的干预措施将需要对药剂师进行培训、提供资源以改善患者的疫苗知识和态度、制定组织战略以简化免疫工作流程,以及改变政策以推进满足农村社区需求的基于药物的免疫服务。
{"title":"Barriers and facilitators to pneumococcal vaccination in rural community pharmacy: A qualitative study","authors":"Leticia E.B. Vieira ,&nbsp;Grace T. Marley ,&nbsp;Tessa J. Hastings ,&nbsp;Salisa C. Westrick ,&nbsp;Ashley H. Chinchilla ,&nbsp;Tyler C. Melton ,&nbsp;Delesha M. Carpenter","doi":"10.1016/j.jvacx.2026.100786","DOIUrl":"10.1016/j.jvacx.2026.100786","url":null,"abstract":"<div><h3>Background</h3><div>Inadequate pneumococcal vaccine uptake in rural U.S. communities remains a significant barrier to effective pneumococcal disease prevention. Community pharmacists are well-positioned to expand vaccine coverage by offering and administering pneumococcal vaccines, but face unique challenges in rural pharmacy settings.</div></div><div><h3>Objective</h3><div>To explore pharmacist-reported barriers and facilitators to pneumococcal vaccination in rural community pharmacies.</div></div><div><h3>Methods</h3><div>Qualitative interviews were conducted with twenty rural pharmacists from a practice-based research network (a collaborative group of community pharmacies engaged in applied research to improve pharmacy practice) across seven U.S. states. Pharmacists were purposefully sampled based on their state and the number of pneumococcal vaccines administered at their pharmacy in the previous year. Interviews assessed factors influencing pneumococcal vaccination across levels of the Social Ecological Framework. Interviews continued until thematic saturation was reached, and iterative thematic analysis of de-identified interview transcripts was conducted until no new themes emerged.</div></div><div><h3>Results</h3><div>Barriers and facilitators to pneumococcal vaccination were identified across all socioecological levels. At the individual level, themes included pharmacists' attitudes, training, and rapport with patients, as well as patients' attitudes, knowledge, and out-of-pocket costs. At the organizational level, themes were related to the pharmacy workflow, staff, time constraints, immunization area, and vaccine stocking costs. Community-level themes involved local physicians, social influences, and factors specific to rural areas. Policy-level themes encompassed vaccination guidelines, states' immunization registries, reimbursement, and immunization regulations.</div></div><div><h3>Conclusion</h3><div>Pneumococcal vaccination in rural community pharmacies is influenced by multilevel factors, including individual, organizational, community, and policy factors. Effective interventions will require training initiatives for pharmacists, resources to improve patients' vaccine knowledge and attitudes, organizational strategies to streamline immunization workflow, and policy changes to advance pharmacy-based immunization services that account for rural community needs.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"29 ","pages":"Article 100786"},"PeriodicalIF":2.2,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The journey towards mRNA vaccine technology transfer: From knowledge to implementation mRNA疫苗技术转让之旅:从知识到实施
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.jvacx.2026.100787
Caryn Fenner , António Lima Grilo , Ike James , Claudia Nannei , Martin Friede , Charles Gore , Marie Paule Kieny , Petro Terblanche
Coronavirus disease 2019 (COVID-19) vaccines were less accessible in low- and middle-income countries (LMICs) than in high-income countries during the pandemic. As a result, vaccine distribution initiatives such as COVID-19 Vaccines Global Access and the African Union's African Vaccine Acquisition Trust were established to guarantee equitable access to COVID-19 vaccines in LMICs. Yet these initiatives alone did not suffice to reverse the inequity.
As a response, the World Health Organization and the Medicines Patent Pool launched the messenger RNA (mRNA) Technology Transfer Programme in June 2021 to support sustainable mRNA vaccine production in LMICs. Afrigen Biologics and Vaccines (Afrigen) in Cape Town, South Africa became the heart of a global collaborative network embarking on a challenging yet innovative journey to develop its first mRNA vaccine, AfriVac 2121, amidst a global pandemic. The World Health Organization also selected 15 manufacturing partners from LMICs in Africa, Europe, South America, and Asia to join the program and receive the mRNA vaccine manufacturing platform.
In this article, we outline the establishment of the programme, its technology transfer strategy, and the progress made in equipping partners with the capacity to implement mRNA technology. We describe the development of the manufacturing platform and pre-clinical validation, and we reflect on the key successes and challenges encountered along the way.
Despite the obstacles, the program has laid the groundwork for a globally distributed, locally driven mRNA vaccine manufacturing ecosystem, and fully equipped the main hub at Afrigen for mRNA vaccine development and manufacturing. Our work underscores the imperative need for sustained investment in technology access, global collaboration, local expertise and infrastructure to ensure equitable access to life-saving vaccines.
在大流行期间,中低收入国家比高收入国家更难获得2019冠状病毒病(COVID-19)疫苗。因此,设立了COVID-19疫苗全球获取和非洲联盟非洲疫苗获取信托基金等疫苗分发倡议,以确保中低收入国家公平获得COVID-19疫苗。然而,仅靠这些举措还不足以扭转这种不平等。作为应对措施,世界卫生组织和药品专利池于2021年6月启动了信使RNA (mRNA)技术转让计划,以支持中低收入国家可持续的mRNA疫苗生产。南非开普敦的Afrigen生物制剂和疫苗(Afrigen)成为全球合作网络的核心,在全球大流行中开始了一项具有挑战性但创新的旅程,以开发其第一种mRNA疫苗AfriVac 2121。世界卫生组织还从非洲、欧洲、南美和亚洲的中低收入国家选择了15个生产伙伴加入该计划,并获得mRNA疫苗生产平台。在本文中,我们概述了该计划的建立,其技术转让战略,以及在使合作伙伴具备实施mRNA技术的能力方面取得的进展。我们描述了生产平台和临床前验证的发展,并反思了在此过程中遇到的关键成功和挑战。尽管存在障碍,但该项目为全球分布、本地驱动的mRNA疫苗生产生态系统奠定了基础,并为Afrigen的mRNA疫苗开发和生产中心提供了充分的装备。我们的工作强调,迫切需要在技术获取、全球合作、地方专门知识和基础设施方面进行持续投资,以确保公平获得拯救生命的疫苗。
{"title":"The journey towards mRNA vaccine technology transfer: From knowledge to implementation","authors":"Caryn Fenner ,&nbsp;António Lima Grilo ,&nbsp;Ike James ,&nbsp;Claudia Nannei ,&nbsp;Martin Friede ,&nbsp;Charles Gore ,&nbsp;Marie Paule Kieny ,&nbsp;Petro Terblanche","doi":"10.1016/j.jvacx.2026.100787","DOIUrl":"10.1016/j.jvacx.2026.100787","url":null,"abstract":"<div><div>Coronavirus disease 2019 (COVID-19) vaccines were less accessible in low- and middle-income countries (LMICs) than in high-income countries during the pandemic. As a result, vaccine distribution initiatives such as COVID-19 Vaccines Global Access and the African Union's African Vaccine Acquisition Trust were established to guarantee equitable access to COVID-19 vaccines in LMICs. Yet these initiatives alone did not suffice to reverse the inequity.</div><div>As a response, the World Health Organization and the Medicines Patent Pool launched the messenger RNA (mRNA) Technology Transfer Programme in June 2021 to support sustainable mRNA vaccine production in LMICs. Afrigen Biologics and Vaccines (Afrigen) in Cape Town, South Africa became the heart of a global collaborative network embarking on a challenging yet innovative journey to develop its first mRNA vaccine, AfriVac 2121, amidst a global pandemic. The World Health Organization also selected 15 manufacturing partners from LMICs in Africa, Europe, South America, and Asia to join the program and receive the mRNA vaccine manufacturing platform.</div><div>In this article, we outline the establishment of the programme, its technology transfer strategy, and the progress made in equipping partners with the capacity to implement mRNA technology. We describe the development of the manufacturing platform and pre-clinical validation, and we reflect on the key successes and challenges encountered along the way.</div><div>Despite the obstacles, the program has laid the groundwork for a globally distributed, locally driven mRNA vaccine manufacturing ecosystem, and fully equipped the main hub at Afrigen for mRNA vaccine development and manufacturing. Our work underscores the imperative need for sustained investment in technology access, global collaboration, local expertise and infrastructure to ensure equitable access to life-saving vaccines.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"29 ","pages":"Article 100787"},"PeriodicalIF":2.2,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Influence of religious affiliation and political news on parental vaccination intent during COVID-19 pandemic COVID-19大流行期间宗教信仰和政治新闻对父母疫苗接种意向的影响
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-08 DOI: 10.1016/j.jvacx.2026.100781
Jake Stevens, Kallysta Strong, Ella Madsen, Jeffrey Glenn, Erik J. Nelson

Background

In May 2021, COVID-19 vaccines became available for adolescents aged 12–15. However, safety concerns, misinformation, and politicization surrounding the vaccine left some parents hesitant to vaccinate their children. This study analyzes how media sources and religious affiliation were associated with parental COVID-19 vaccination intent.

Methods

We conducted a cross-sectional analysis of 5552 parents in the May 2021 COVID-19 Rapid Research Response Survey of the Adolescent Brain Cognitive Development (ABCD) study, which collected data on parental intention to vaccinate their children against COVID-19 just before the FDA approved the first vaccine for children aged 12–15. Parental vaccination intent was analyzed by media sources, religious affiliation, and other sociodemographic factors. We also fit a log-binomial regression model to examine the impact of media sources and religious affiliation on parental vaccination intent, controlling for sociodemographic factors.

Results

We found that, compared to parents consuming balanced media sources, parents consuming right-leaning media sources were less likely to plan to vaccinate their children [PR = 0.53 (0.47, 0.6)], while parents consuming left-leaning media sources were not significantly different from parents consuming balanced media [PR = 1.06 (0.99, 1.12)]. We also found differences in vaccination intent by religious affiliation. Compared to Christian parents, Agnostic/Atheist parents were more likely to plan to vaccinate their children [PR = 1.41 (1.35, 1.47)], as were Jewish parents [PR = 1.32 (1.22, 1.43)], and parents with no religious affiliation [(PR = 1.18 (1.14, 1.23)].

Conclusions

Our study highlights the multifaceted factors influencing vaccine hesitancy among parents of adolescents during the COVID-19 pandemic. To create effective public health strategies for future outbreaks, it is crucial to better understand the complex interplay of religious affiliation and media bias with vaccine hesitancy.
2021年5月,为12-15岁青少年提供了COVID-19疫苗。然而,围绕疫苗的安全担忧、错误信息和政治化使得一些家长对是否给孩子接种疫苗犹豫不决。本研究分析了媒体来源和宗教信仰与父母COVID-19疫苗接种意图的关系。方法:在2021年5月2019冠状病毒病青少年大脑认知发展快速研究反应调查(ABCD)研究中,我们对5552名父母进行了横断面分析,该研究收集了父母在FDA批准首个针对12-15岁儿童的疫苗之前为孩子接种COVID-19疫苗的意向数据。通过媒体来源、宗教信仰和其他社会人口因素分析父母接种疫苗的意向。我们还拟合了一个对数二项回归模型来检验媒体来源和宗教信仰对父母接种疫苗意图的影响,控制了社会人口因素。结果我们发现,与使用平衡媒体的父母相比,使用右倾媒体的父母更不愿意为孩子接种疫苗[PR = 0.53(0.47, 0.6)],而使用左倾媒体的父母与使用平衡媒体的父母没有显著差异[PR = 1.06(0.99, 1.12)]。我们还发现不同宗教信仰在疫苗接种意向上存在差异。与基督徒父母相比,不可知论者/无神论者父母更有可能计划给孩子接种疫苗[PR = 1.41(1.35, 1.47)],犹太父母[PR = 1.32(1.22, 1.43)]和无宗教信仰的父母[PR = 1.18(1.14, 1.23)]也是如此。结论本研究揭示了新冠肺炎大流行期间影响青少年父母疫苗犹豫的多方面因素。为了为未来的疫情制定有效的公共卫生战略,必须更好地了解宗教信仰和媒体偏见与疫苗犹豫之间的复杂相互作用。
{"title":"Influence of religious affiliation and political news on parental vaccination intent during COVID-19 pandemic","authors":"Jake Stevens,&nbsp;Kallysta Strong,&nbsp;Ella Madsen,&nbsp;Jeffrey Glenn,&nbsp;Erik J. Nelson","doi":"10.1016/j.jvacx.2026.100781","DOIUrl":"10.1016/j.jvacx.2026.100781","url":null,"abstract":"<div><h3>Background</h3><div>In May 2021, COVID-19 vaccines became available for adolescents aged 12–15. However, safety concerns, misinformation, and politicization surrounding the vaccine left some parents hesitant to vaccinate their children. This study analyzes how media sources and religious affiliation were associated with parental COVID-19 vaccination intent.</div></div><div><h3>Methods</h3><div>We conducted a cross-sectional analysis of 5552 parents in the May 2021 COVID-19 Rapid Research Response Survey of the Adolescent Brain Cognitive Development (ABCD) study, which collected data on parental intention to vaccinate their children against COVID-19 just before the FDA approved the first vaccine for children aged 12–15. Parental vaccination intent was analyzed by media sources, religious affiliation, and other sociodemographic factors. We also fit a log-binomial regression model to examine the impact of media sources and religious affiliation on parental vaccination intent, controlling for sociodemographic factors.</div></div><div><h3>Results</h3><div>We found that, compared to parents consuming balanced media sources, parents consuming right-leaning media sources were less likely to plan to vaccinate their children [PR = 0.53 (0.47, 0.6)], while parents consuming left-leaning media sources were not significantly different from parents consuming balanced media [PR = 1.06 (0.99, 1.12)]. We also found differences in vaccination intent by religious affiliation. Compared to Christian parents, Agnostic/Atheist parents were more likely to plan to vaccinate their children [PR = 1.41 (1.35, 1.47)], as were Jewish parents [PR = 1.32 (1.22, 1.43)], and parents with no religious affiliation [(PR = 1.18 (1.14, 1.23)].</div></div><div><h3>Conclusions</h3><div>Our study highlights the multifaceted factors influencing vaccine hesitancy among parents of adolescents during the COVID-19 pandemic. To create effective public health strategies for future outbreaks, it is crucial to better understand the complex interplay of religious affiliation and media bias with vaccine hesitancy.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"29 ","pages":"Article 100781"},"PeriodicalIF":2.2,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145980700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A qualitative exploration of stakeholders' views on vaccines for the elderly in South Africa 对利益攸关方对南非老年人疫苗的看法进行定性探讨
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-07 DOI: 10.1016/j.jvacx.2026.100779
Mncengeli Sibanda , Rosemary J. Burnett , Brian Godman , Edina Amponsah-Dacosta , Johanna C. Meyer

Background and objectives

Advancements in healthcare and living standards have led to increased life expectancy globally, including in South Africa. Despite considerable evidence from high-income countries that vaccination is a cost-effective strategy for healthy ageing, South Africa currently does not have a formal policy for vaccination of the elderly. This study explored the opinions, experiences and recommendations of South African stakeholders (experts and key opinion leaders) in the field of vaccines and healthy ageing.

Methodology

Online qualitative in-depth interviews with 16 stakeholders (vaccinologists, infectious disease specialists, policymakers, geriatricians and epidemiologists) were conducted. Interviews were recorded, transcribed, coded and analysed thematically using NVivo 12.0™ software.

Results

The overarching unanimous theme was that a national immunisation programme for the elderly (NIPE) is warranted. Aligned to this were the themes: (i) Immunisation schedule for the elderly; (ii) Health system NIPE readiness; and (iii) Strategies ensuring adequate vaccine uptake by the elderly. Participants recommended a coordinated NIPE, which could build on the successes of the Expanded Programme on Immunisation of South Africa (EPI-SA) and the recent COVID-19 vaccination programme. The NIPE should ideally be integrated into the existing primary healthcare (PHC) system programmes for the elderly. Concurrently, interventions to increase access to vaccines and reduce vaccine hesitancy among the elderly and their healthcare providers must be implemented.

Conclusion

A NIPE needs to be prioritised, understood, communicated, and implemented within EPI-SA and integrated into the PHC system. This should be accompanied by the requisite logistical and financial support for such a programme. The NIPE should build on the success and achievements of EPI-SA and the COVID-19 vaccination programme. Interventions that increase vaccine access and address vaccine hesitancy should also be implemented to enhance uptake by the elderly.
背景和目标医疗保健和生活水平的提高导致全球预期寿命延长,包括南非。尽管来自高收入国家的大量证据表明,疫苗接种是健康老龄化的一项具有成本效益的战略,但南非目前尚无老年人疫苗接种的正式政策。这项研究探讨了南非利益攸关方(专家和主要意见领袖)在疫苗和健康老龄化领域的意见、经验和建议。方法对16名利益攸关方(疫苗学家、传染病专家、政策制定者、老年病学家和流行病学家)进行了在线定性深入访谈。使用NVivo 12.0™软件对访谈进行记录、转录、编码和主题分析。结果:总体一致的主题是,有必要制定国家老年人免疫规划(NIPE)。与此相一致的主题是:(i)老年人免疫接种计划;卫生系统NIPE准备情况;㈢确保老年人充分接种疫苗的战略。与会者建议建立一个协调一致的国家免疫规划,以南非扩大免疫规划(EPI-SA)和最近的COVID-19疫苗接种规划的成功为基础。理想情况下,NIPE应纳入现有的老年人初级卫生保健(PHC)系统方案。与此同时,必须实施干预措施,以增加获得疫苗的机会,减少老年人及其卫生保健提供者对疫苗的犹豫。结论NIPE需要在EPI-SA中优先考虑、理解、沟通和实施,并整合到PHC系统中。同时还应为这一方案提供必要的后勤和财政支助。NIPE应以EPI-SA和COVID-19疫苗接种规划的成功和成就为基础。还应实施增加疫苗获取和解决疫苗犹豫问题的干预措施,以提高老年人的接种率。
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引用次数: 0
Longitudinal survey of 6-monthly booster vaccination-induced antibody responses to equine influenza A virus (H3N8) in Standardbred trotting horses in training 标准小跑马6个月强化疫苗诱导的马甲型流感病毒(H3N8)抗体反应的纵向调查
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-06 DOI: 10.1016/j.jvacx.2026.100778
Eva Wattrang , Helena Back , Louise Treiberg Berndtsson , Siamak Zohari , Janet Daly
Vaccination is an established and important tool in preventing the impact of influenza in the horse population but the frequency of booster vaccinations after the primary course of vaccinations to maintain protective antibody levels is still under debate. The aim of this field study was to monitor equine influenza antibody levels over the course of 13 months during which horses were given two booster vaccinations.
Fifty-six vaccinated Standardbred trotters in training were monitored with monthly blood samples. The horses were routinely vaccinated with a commercial equine influenza vaccine 6 months apart, V1 and V2. Antibodies to vaccine strain A/equine/Borlänge/91 (Bor/91) were quantified by ELISA in all samples and also measured by single radial haemolysis (SRH) in samples obtained before and after V1.
Mean titres against Bor/91 determined by ELISA were at the lowest level in the month prior to V1. All horses sampled immediately before and after V1 had an increase in titre except two ≥ 4-year-old horses. The antibody titres declined rapidly in the 3 months after V1. The boosting effect of V2 was lower compared to that of V1 and six horses with high pre-vaccination titres did not respond to V2, irrespective of age. Titres estimated by ELISA correlated well with antibody levels determined by SRH, which showed that while many of the horses would be unprotected before V1, antibody levels were boosted to protective levels after vaccination.
Antibody responses were higher in horses with low antibody levels at booster vaccination compared to those with already high antibody levels.
疫苗接种是预防流感对马群影响的既定和重要工具,但在初级疫苗接种后加强疫苗接种的频率以保持保护性抗体水平仍存在争议。这项实地研究的目的是监测马流感抗体水平在13个月的过程中,马给予两次加强疫苗接种。对56只接种过疫苗的标准种马进行了月度血液样本监测。这些马按常规间隔6个月接种商业马流感疫苗V1和V2。所有样品均采用ELISA法测定A/马/Borlänge/91 (Bor/91)疫苗株抗体,V1前后样品采用单径向溶血(SRH)法测定。酶联免疫吸附试验测定的抗体平均滴度在V1前一个月为最低水平。除2匹≥4岁的马外,所有在V1之前和之后立即取样的马的滴度都有所增加。抗体滴度在V1后3个月内迅速下降。与V1相比,V2的增强作用较低,6匹接种前滴度高的马对V2没有反应,与年龄无关。ELISA估计的滴度与SRH测定的抗体水平相关性很好,这表明虽然许多马在V1之前是不受保护的,但接种疫苗后抗体水平提高到保护水平。与那些抗体水平已经很高的马相比,在加强疫苗接种时抗体水平较低的马的抗体反应更高。
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引用次数: 0
Real-world estimation of the pneumococcal vaccination coverage among high-risk population in the unified health system in Brazil: an administrative database analysis 巴西统一卫生系统中高危人群肺炎球菌疫苗接种覆盖率的实际估计:行政数据库分析
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.jvacx.2026.100780
Daniela V. Pachito , Paulo H.R.F. Almeida , Ricardo Macarini Ferreira , Rodrigo F. Alexandre , Ana Paula N. Burian

Background

Immunization against pneumococcal disease (PD) for individuals with certain coexisting health conditions is recommended by the National Immunization Program (NIP) in the Unified Health System (SUS) in Brazil. There are uncertainties regarding the size of the population at risk and the proportion of high-risk individuals assessed at the Reference Centers for Special Immunobiologicals (Centros de Referência para Imunobiológicos Especiais, CRIE). Objectives were to assess the high-risk population size from a claims database, to estimate the vaccination coverage rate, and to assess the proportion of complete, incomplete and non-conforming vaccination schemes.

Methods

ICD-10 and procedure codes related to high-risk health conditions were defined, together with proxies of disease activity and severity. Data from the outpatient information system of medium-to-high complexity levels of care, and the information system of immunobiologicals were analyzed. Encrypted identifiers were used to count distinct individuals from November 2021 to October 2023. Complete vaccination scheme was defined as at least one PCV13 and two or more PPS23 doses; incomplete vaccination scheme as one PCV13 and less than two PPS23 doses; and non-conform vaccination scheme as more than one PCV13 and less than two PPS23 doses.

Results

The estimated size of the high-risk population was 1,609,181 individuals. Coverage rate for having received at least one dose of PCV13 was estimated at 45.5 % and for the complete vaccination scheme at 3.5 %. Most vaccination schemes were incomplete or non-conform.

Conclusion

A small proportion of high-risk individuals were considered as having received the complete pneumococcal vaccination scheme, possibly due to issues such as the high complexity of the vaccination scheme, and limited access to CRIE, due to the continental size of Brazil and the concentration of CRIE in large cities. These findings should be interpreted with caution, considering the inherent limitations of the data sources used.
背景:巴西统一卫生系统(SUS)的国家免疫计划(NIP)建议对患有某些共存健康状况的个体接种肺炎球菌病(PD)疫苗。在特殊免疫生物制剂参考中心(centeros de Referência para Imunobiológicos Especiais, CRIE)评估的高危人群规模和高危人群比例存在不确定性。目的是从索赔数据库中评估高危人群的规模,估计疫苗接种覆盖率,评估完整、不完整和不符合疫苗接种方案的比例。方法定义与高危健康状况相关的sicd -10和程序代码,以及疾病活动性和严重程度的指标。分析来自中高复杂程度门诊信息系统和免疫生物制剂信息系统的数据。从2021年11月到2023年10月,加密标识符被用来计算不同的个体。完整的疫苗接种计划定义为至少一次PCV13和两次或更多PPS23剂量;不完整的疫苗接种计划为1剂PCV13和少于2剂PPS23;和不符合的疫苗接种计划,超过一个PCV13和少于两个PPS23剂量。结果高危人群估计规模为1,609,181人。接种至少一剂PCV13疫苗的接种率估计为45.5%,完整疫苗接种计划的接种率估计为3.5%。大多数疫苗接种计划不完整或不符合规定。结论一小部分高危人群被认为接受了完整的肺炎球菌疫苗接种计划,这可能是由于疫苗接种计划的高度复杂性,以及由于巴西幅员辽阔、疫苗接种主要集中在大城市,疫苗接种计划的可及性有限等问题。考虑到所使用的数据来源的固有局限性,应谨慎解释这些发现。
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引用次数: 0
Countrywide analysis of vaccination rates in Ecuador from 2014 to 2024: Trends, inequalities and public health implications 2014年至2024年厄瓜多尔全国疫苗接种率分析:趋势、不平等和公共卫生影响
IF 2.2 Q3 IMMUNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.jvacx.2025.100770
Carolina Villacreses, Juan S. Izquierdo-Condoy, Jorge Vasconez-Gonzalez, María Gabriela Dávila-Rosero, Andrea Tello-De-la-Torre, Andres López-Cortes, Esteban Ortiz-Prado

Background

National vaccination coverages are a key public health indicator and a cornerstone of disease prevention. In Ecuador, coverage rates have varied across age groups, highlighting both advancements and ongoing challenges. This study aims to analyze national vaccination coverage trends, identify regional disparities, and discuss possible factors influencing immunization rates in the country.

Methods

A nationwide descriptive analysis of vaccination coverage in Ecuador was conducted using official coverage data from 2014 to 2024, derived from aggregate counts reported by health facilities and census-based population estimates, despite limitations due to the absence of a fully functional electronic immunization registry. The study examined vaccine administration across different age groups, including children under one year, children aged 12 to 59 months, school-age children (5 to 15 years), and adults. Descriptive statistics were applied to assess coverage trends over multiple years, and variations by geographic region were analyzed.

Results

Vaccination coverage in Ecuador showed marked fluctuations from after 2014 up to 2024. BCG coverage dropped from 90 % pre-pandemic to 75 % in 2021, peaked at 98 % in 2023, then declined to 85 % in 2024. Hepatitis B birth dose fell to 47 % in 2016, recovering to 72 % by 2024. HPV1 dropped from 98 % (2018) to 28 % (2021), rebounding to 82 % in 2023; HPV2 remained lower at 52 %. Adult Td coverage was consistently low (9 % in 2021; 40 % in 2024). Booster doses also declined during the pandemic. Regional disparities persisted, with some areas exceeding 90 % while others remained below 70 %.

Conclusions

The national analysis of vaccination coverage in Ecuador highlights both progress and persistent gaps. While early childhood vaccines show high coverage, deficiencies remain in booster doses, adolescent immunization, and adult vaccination. Strengthening outreach, improving equitable access, and addressing regional disparities are essential to sustain immunization rates and prevent vaccine-preventable diseases. In addition, it is necessary to gain a better understanding of the problems and barriers that affect vaccination coverage to design tailored interventions. Further studies are needed to understand the causes of vaccination gaps between rural and urban areas, so as to develop strategies that reduce these inequalities.
国家疫苗接种覆盖率是一项关键的公共卫生指标,也是疾病预防的基石。在厄瓜多尔,不同年龄组的覆盖率各不相同,既突出了进步,也突出了持续的挑战。本研究旨在分析国家疫苗接种覆盖率趋势,确定区域差异,并讨论影响该国免疫接种率的可能因素。方法利用2014年至2024年厄瓜多尔疫苗接种覆盖率的官方数据对该国进行了全国性的描述性分析,这些数据来自卫生机构报告的总数和基于人口普查的人口估计数,尽管由于缺乏功能齐全的电子免疫登记而受到限制。该研究调查了不同年龄组的疫苗接种情况,包括一岁以下儿童、12至59个月儿童、学龄儿童(5至15岁)和成年人。使用描述性统计来评估多年来的覆盖趋势,并分析了地理区域的变化。结果2014年以后至2024年,厄瓜多尔疫苗接种覆盖率出现明显波动。BCG覆盖率从大流行前的90%降至2021年的75%,在2023年达到98%的峰值,然后在2024年降至85%。2016年乙肝出生剂量降至47%,到2024年恢复至72%。hpv从98%(2018年)下降到28%(2021年),到2023年反弹到82%;hpv病毒仍然较低,为52%。成人Td覆盖率一直很低(2021年为9%,2024年为40%)。在大流行期间,加强剂量也有所下降。区域差异仍然存在,一些地区超过90%,而另一些地区仍低于70%。结论厄瓜多尔疫苗接种覆盖率的全国分析突出了进展和持续存在的差距。虽然儿童早期疫苗的覆盖率很高,但在加强剂量、青少年免疫和成人疫苗接种方面仍然存在不足。加强外联、改善公平获取和解决区域差异对于维持免疫接种率和预防疫苗可预防的疾病至关重要。此外,有必要更好地了解影响疫苗接种覆盖率的问题和障碍,以便设计有针对性的干预措施。需要进一步研究以了解农村和城市地区之间疫苗接种差距的原因,以便制定减少这些不平等的战略。
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引用次数: 0
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Vaccine: X
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