{"title":"Novel nanoemulsion adjuvant stabilized by TPGS possesses equivalent physicochemical properties, Turbiscan stability, and adjuvanticity to AS03 for eliciting robust immunogenicity of subunit vaccines in mice.","authors":"Quanyi Yin, Shuoyao Song, Zhilei Liu","doi":"10.1080/21645515.2025.2486635","DOIUrl":"10.1080/21645515.2025.2486635","url":null,"abstract":"<p><p>Emulsion-based antigen delivery systems have emerged as a novel approach to enhance the effectiveness of subunit vaccines. This study presents the development of a newly formulated oil-in-water (o/w) nanoemulsion adjuvant (NEA) composed of squalene oil and α-tocopheryl polyethylene glycol 1000 succinate (TPGS), which serves dual roles as an emulsifier and an immunostimulator. In comparison to AS03, an FDA-approved emulsion adjuvant that includes α-tocopherol, squalene, and polysorbate 80, NEA is devoid of α-tocopherol and exhibits comparable physicochemical properties, including particle size, polydispersity index, morphology, pH, zeta potential, and viscosity. Stability assessments conducted using Turbiscan Lab indicated that NEA undergoes an uplift process without experiencing flocculation, agglomeration or delamination. Model subunit antigens of recombinant glycoprotein E (gE) targeting the varicella-zoster virus (VZV) and highly purified hemagglutinin (HA) protein against trivalent seasonal influenza viruses (TIV) were employed to assess the adjuvanticity of NEA. It was revealed that the specific anti-gE IgG titers induced by the gE/NEA were markedly higher than those generated by gE alone, with titers of 13,000 <i>vs</i> 3,000 for the primary vaccination, and 5 × 10<sup>6</sup> <i>vs</i> 5 × 10<sup>4</sup> for the booster vaccination. Additionally, the TIV/NEA group exhibited a significantly improved immunogenic response relative to TIV alone across all three HA antigens at six-week after immunization, as evidenced by anti-HA titers of 256 <i>vs</i> 32. Furthermore, the NEA demonstrated no significant difference in efficacy compared to AS03 in both the VZV and TIV vaccines. Consequently, NEA presents a promising alternative to AS03 for the development of effective subunit vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2486635"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143765604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kaushal Sharma, Safia Syeda, Sanket M Shah, Sonali A Kori, Pratiksha Shetty, Saniya Kazi, Archana Khaiterpal, Aasiya Choudhary, Sarang Pathak, Syed Ahmed
{"title":"Overcoming barriers to medical countermeasures: Strengthening global biosecurity.","authors":"Kaushal Sharma, Safia Syeda, Sanket M Shah, Sonali A Kori, Pratiksha Shetty, Saniya Kazi, Archana Khaiterpal, Aasiya Choudhary, Sarang Pathak, Syed Ahmed","doi":"10.1080/21645515.2025.2483043","DOIUrl":"10.1080/21645515.2025.2483043","url":null,"abstract":"<p><p>The COVID-19 pandemic revealed global disparities in accessing medical countermeasures, as high-income countries prioritised their own interests while disregarding low- and middle-income countries. Despite global efforts to ensure an equitable pandemic response, these initiatives largely failed to achieve their objectives for LMICs due to systemic inequalities. This review critically examines these disparities, identifying that excessive stockpiling by HICs, fragmented international coordination, inadequate research and manufacturing capacity, restricted access to emergency research funding, intellectual property constraints, unequal participation in clinical trials, and inadequate regulatory harmonisation collectively hinder LMICs ability to respond effectively. By analysing diverse case scenarios and global response strategies, all plausible key shortcomings that contributed to the failure of coordinated pandemic preparedness were highlighted. Based on these insights, actionable strategies are proposed to address these gaps in LMICs so as to ensure affordability, accessibility, and equitable distribution of vaccines, diagnostics, and biotherapeutics in future public health emergencies, strengthening global biosecurity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2483043"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143711840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Diverse processes in rotavirus vaccine development.","authors":"Xiaochen Lin, Hongjun Li","doi":"10.1080/21645515.2025.2475609","DOIUrl":"10.1080/21645515.2025.2475609","url":null,"abstract":"<p><p>Rotavirus is a major cause of severe diarrhea and mortality in children under five years of age, leading to approximately 128,500 deaths annually.<sup>1</sup><sup>-3</sup> Vaccination is the most effective strategy for preventing rotavirus infection. While two widely used vaccines, Rotarix and RotaTeq, have shown good efficacy in high-income countries, their effectiveness is lower in low- and middle-income countries due to factors such as malnutrition and poor sanitation.<sup>4</sup><sup>-6</sup> These challenges include complex vaccination schedules and high production costs. Researchers are working on novel vaccines, including inactivated virus and viral protein-based options, as well as virus-like particles and recombinant proteins.<sup>7</sup><sup>-9</sup> Improving vaccine stability and applicability is crucial for resource-limited settings, and global vaccination strategies are expected to significantly reduce infection burdens, improve child health, and contribute to the achievement of global health goals.<sup>10</sup><sup>-14</sup>.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2475609"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sanchari Paul, Mustafa Kaya, Olivia Johnsson, Hanna Grauers Wiktorin, Andreas Törnell, Mohammad Arabpour, Kristoffer Hellstrand, Anna Martner
{"title":"Targeting murine metastatic cancers with cholera toxin A1-adjuvanted peptide vaccines.","authors":"Sanchari Paul, Mustafa Kaya, Olivia Johnsson, Hanna Grauers Wiktorin, Andreas Törnell, Mohammad Arabpour, Kristoffer Hellstrand, Anna Martner","doi":"10.1080/21645515.2025.2455240","DOIUrl":"10.1080/21645515.2025.2455240","url":null,"abstract":"<p><p>The dissemination of tumor cells with ensuing metastasis is responsible for most cancer-related deaths. Cancer vaccines may, by inducing tumor-specific effector T cells, offer a strategy to eliminate metastasizing tumor cells. However, several obstacles remain in the development of effective cancer vaccines, including the identification of adjuvants that enhance the evolvement and efficacy of tumor-specific T cells. Cholera toxin-based adjuvants have shown efficacy in vaccines for infectious diseases, but their role in cancer vaccine therapies remains to be elucidated. Here, we explored the potential of cholera toxin A1 (CTA1)-based adjuvants to boost anti-tumor T cell responses and protect against metastasis. We report that an adjuvant where CTA1 was fused to a dimer from <i>Staphylococcus aureus</i> protein A (DD) enhanced immune responses against the tumor-associated antigens TRP2 and Twist1 in mice, providing protection against B16F1 melanoma and 4T1 breast cancer metastasis, respectively. Both mucosal (intranasal) and systemic (intraperitoneal) vaccine administration provided effective protection against intravenously injected tumor cells, with intranasal administration leading to superior induction of CD4<sup>+</sup> T cells at metastatic sites. When comparing antigens admixed with CTA1-DD to those fused with a CTA1-based adjuvant, the fusion construct elicited the strongest immunogenicity. Nevertheless, by administrating a 20-fold higher antigen dose also the admix formulation provided efficient protection against metastasis.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2455240"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760229/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Global research progress in antibody-drug conjugates for solid tumors: Bibliometrics and visualized analysis.","authors":"Wenjun Fang, Xueqing Ma, Ben Liu","doi":"10.1080/21645515.2025.2472493","DOIUrl":"10.1080/21645515.2025.2472493","url":null,"abstract":"<p><p>Recently, the use of antibody-drug conjugates (ADCs) in the research and management of solid tumors has increased, making them a key focus in the field of oncology. In this study, we performed a comprehensive literature review of ADCs use in solid tumor treatment. We retrieved data from the Web of Science Core Collection (WoSCC). Following literature retrieval, we conducted a thorough bibliometric and knowledge-mapping analysis of the collected articles. There was a rapid growth in the number of annual publications in this field. The United States had the highest publication volumes and led ADC research for solid tumors. Additionally, The Dana-Farber Cancer Institute had the highest output, and G. Curigliano was identified as the most productive author. The journal \"<i>Cancers</i>\" led in the publishing of ADC research on solid tumors. Furthermore, key clustering terms such as \"breast cancer,\" \"targeted therapy,\" \"bladder cancer,\" \"ovarian cancer,\" \"expression,\" and \"drug delivery\" emerged in this field as the research progressed. We identified six key themes by literature co-citation analysis, involving the research on the application of four ADCs in breast cancer, as well as the analysis of ADCs design, mechanisms, and strategies for reducing cytotoxicity. At the same time, based on the analysis of papers that have experienced a citation burst recently, we explored the future development trends of this field. Overall, our inaugural bibliometric analysis of ADCs for solid tumor research provides a systematic framework to guide future studies in this field. Therefore, facilitating and promoting further development in this area.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2472493"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869778/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yang Liu, Jing Chen, Ning Yao, Xiaoxiao Hu, Nian Yu, Qing Wang, Jiawei Xu
{"title":"Pertussis epidemiological surveillance and immunization history in children under five years in a megacity in China from 2019 to 2023.","authors":"Yang Liu, Jing Chen, Ning Yao, Xiaoxiao Hu, Nian Yu, Qing Wang, Jiawei Xu","doi":"10.1080/21645515.2025.2460273","DOIUrl":"10.1080/21645515.2025.2460273","url":null,"abstract":"<p><p>To analyze the epidemiological characteristics and influencing factors of pertussis in children under five years in Chongqing from 2019 to 2023, providing scientific evidence for further prevention and control. The epidemiological characteristics of pertussis cases in children under five years and vaccination history with pertussis-containing vaccines were described, and the influencing factors and cumulative risk of disease onset after vaccination were analyzed using the Cox proportional hazards regression model. From 2019 to 2023, a total of 4,135 pertussis cases were reported in children under five years in Chongqing, with cases occurring predominantly between April and August. Infants under 1 year accounted for the highest proportion of cases at 66.82% (2,763/4,135); the annual reported incidence was higher in boys (141.26/100,000) than in girls (122.09/100,000). Over half of the cases, 59.78% (2,472/4,135) had received at least one dose of a pertussis-containing vaccine, and there were significant differences in vaccination history among different age groups (χ<sup>2</sup> = 483.248, <i>p</i> < .01). Cox's regression analysis indicated that the total number of doses received (<i>p</i> < .01) was an influencing factor for the interval between vaccination and disease onset. The hazard ratios (HRs) for three doses, two doses, and one dose were 0.182 (95% CI: 0.138-0.241), 0.485 (95% CI: 0.359-0.654), and 0.315 (95% CI: 0.233-0.425). Young children, including infants and preschool-aged children, were still a high-risk group for pertussis infection in Chongqing. It is recommended to administer an additional dose of Diphtheria-Tetanus-Pertussis vaccine (DTaP) vaccine to preschool children aged four to six in China.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2460273"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11812399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Uncovering global research frontiers in deubiquitinating enzymes and immunotherapy: A bibliometric study.","authors":"Xia Chen, Yang Qin, Jinfeng Gan, Tangwen Wei, Xinyi Wei, Yaling Xiong, Zhichang Zhang, Bing Wei","doi":"10.1080/21645515.2025.2483558","DOIUrl":"10.1080/21645515.2025.2483558","url":null,"abstract":"<p><p>Recently, immunotherapy has been a key therapeutic strategy for cancer. Deubiquitinating enzymes (DUBs), which are protein-modifying enzymes, have a crucial role in the pathogenesis of cancer, autoimmune diseases, and inflammation. DUBs influence the tumor immune microenvironment by regulating immune cell functions and key signaling pathways. Thus, the potential applications of DUBs in immunotherapy have piqued the interest of the scientific community. This study performed bibliometric analysis to comprehensively examine the research hotspots and trends in this field, providing theoretical foundations and guidance for future research. Studies associated with DUBs and immunotherapy conducted over a decade (2014 to 2024) were searched and extracted from Web of Science Collection database. The analysis was performed using CiteSpace, VOSviewer, and the Bibliometrix package in R software. Visualizations were generated for countries, institutions, authors, journals, references, and keyword co-occurrences. In total, 321 articles related to DUBs and immunotherapy were retrieved. The number of publications increased markedly since 2020. China had the highest number of publications, while the United States exerted the most influence in this field. Zhang Jinfang was the most influential author in this field. Zhejiang University was the institution with the highest number of publications. Nature was the most cited journal (807 total citations). Keyword analysis revealed that the primary research hotspots were expression, immunotherapy, ubiquitination, degradation, and cancer. This bibliometric analysis revealed the research trends and emerging frontiers in DUBs and immunotherapy, offering novel strategies for the application of DUBs in immunotherapy.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2483558"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Seyed Mohammad Mahdi Moshirian Farahi, Rose Darly Dalexis, Idrissa Beogo, Léa Gakima, Jude Mary Cénat
{"title":"COVID-19 vaccine confidence among parents of racially diverse children aged 0-12 years old in Canada: The role of major experience of racial discrimination, health literacy, and conspiracy beliefs.","authors":"Seyed Mohammad Mahdi Moshirian Farahi, Rose Darly Dalexis, Idrissa Beogo, Léa Gakima, Jude Mary Cénat","doi":"10.1080/21645515.2025.2484895","DOIUrl":"10.1080/21645515.2025.2484895","url":null,"abstract":"<p><p>The success of COVID-19 vaccination is linked to trust, hesitancy, and confidence. Racial discrimination impacts vaccine hesitancy and trust, particularly in racialized groups. This study investigates factors influencing COVID-19 vaccine confidence among Canadian parents from different racial groups, addressing a gap in existing research. Data were collected in 2023 (October to November) included 2,528 parents of children aged 0-12. Findings showed significant mean differences between racial groups, <i>F</i> (7, 2520) = 9.92, <i>p</i> < .001, with Arabs presented lower means of confidence (<i>M</i> = 30.26, <i>SD</i> = 9.39) compared to Asian (<i>M</i> = 35.71, <i>SD</i> = 8.14), Black (<i>M</i> = 33.23, <i>SD</i> = 9.50), and Indigenous parents (<i>M</i> = 35.07, <i>SD</i> = 9.45). Multiple linear regression among White participants showed that conspiracy beliefs were negatively associated with COVID-19 vaccine confidence (<i>β</i> = -.60, <i>p</i> < .001), whereas health literacy was positively associated with COVID-19 vaccine confidence (<i>β</i> = .09, <i>p</i> < .001). Results among racialized groups showed that conspiracy beliefs (<i>β</i> = -.23, <i>p</i> < .001) and racial discrimination (<i>β</i> = -.05, <i>p</i> = .049) were negatively associated with COVID-19 vaccine confidence, while health literacy was positively associated with COVID-19 vaccine confidence (<i>β</i> = .31, <i>p</i> < .001). This study highlights the complex factors influencing COVID-19 vaccine confidence among Canadian parents from racialized groups, suggesting that racial discrimination and conspiracy beliefs significantly reduce vaccine confidence, while health literacy plays a crucial role in increasing confidence. These results underscore the importance of addressing misinformation and systemic barriers to trust in vaccination efforts.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2484895"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11959898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China.","authors":"Yiqing Zhu, Yihan Wang, Jinghui Wang, Yafei Wang, Li Sun, Shiheng Cui, Jing Li, Yu Guo","doi":"10.1080/21645515.2025.2458831","DOIUrl":"10.1080/21645515.2025.2458831","url":null,"abstract":"<p><p>To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4-5 years- group (<i>χ</i><sup><i>2</i></sup> = 13.90, <i>p</i> = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2458831"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiang Sun, Lei Zhang, Tingting Zhang, Jinning Sun, Yan Xu, Li Liu, Yuan Bao Liu, Ran Hu, YaLi Fu, Zhiguo Wang, Hui Sun
{"title":"Surveillance on the coverage of herpes zoster vaccine and post-marketing adverse events in Jiangsu province, China.","authors":"Xiang Sun, Lei Zhang, Tingting Zhang, Jinning Sun, Yan Xu, Li Liu, Yuan Bao Liu, Ran Hu, YaLi Fu, Zhiguo Wang, Hui Sun","doi":"10.1080/21645515.2025.2449714","DOIUrl":"https://doi.org/10.1080/21645515.2025.2449714","url":null,"abstract":"<p><p>To analyze the coverage rate of adult herpes zoster (HZ) vaccine and the incidence of Adverse event following immunization (AEFI) in Jiangsu province, China. The vaccination information of HZ vaccine in people aged 50 years and above in Jiangsu province in 2023 and the AEFI information of HZ vaccine from 2020 to 2023 were collected through the Jiangsu Province vaccination management information system and China AEFI information management system, and the vaccination rate and AEFI incidence of HZ vaccine were analyzed. The overall vaccination rate among individuals aged 50 years and above was merely 0.19%. About 20% of vaccinated individuals (12,821 people) received only the first dose, failing to complete the recommended two-dose regimen. A total of 43 and 217 cases of AEFIs following vaccination were reported after administration of the HZ vaccine during the periods of 2020-2021 and 2022-2023, respectively, resulting in reporting rates (RRs) of 240.7 and 201.2 per 100,000 doses, correspondingly. The majority of AEFIs following vaccination with HZ vaccines were common reactions, while rare reactions and coincidental events accounted for only 1.5% and 0.4% of cases, respectively. Over 55% of AEFIs occurred within 30 minutes post-vaccination , with fever, allergic eruptions, and drowsiness being the most reported systemic symptoms, and redness and induration being the main symptoms at the injection site. Despite the proven safety profile of the HZ vaccine, its coverage remains significantly low among individuals aged 50 years and above in Jiangsu Province, China as of 2023. The majority of AEFIs were mild and commonly observed. To enhance the comprehensiveness of post-marketing safety data, it is imperative to conduct further active surveillance studies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2449714"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}