Neisha Sundaram, Ambuja Kowlgi, Biswamitra Sahu, Gvs Murthy, Clarence C Tam
{"title":"Maternal vaccination decision-making in urban and rural Bengaluru, India: A mixed methods study.","authors":"Neisha Sundaram, Ambuja Kowlgi, Biswamitra Sahu, Gvs Murthy, Clarence C Tam","doi":"10.1080/21645515.2025.2506849","DOIUrl":"https://doi.org/10.1080/21645515.2025.2506849","url":null,"abstract":"<p><p>Maternal immunization is key to reducing morbidity and mortality among both pregnant women and infants; however, improving maternal vaccination uptake remains a challenge globally. We conducted a mixed methods study using a social ecological model in urban and rural sites in Bengaluru, India, to examine vaccination decision-making and factors influencing vaccination during pregnancy at the individual, interpersonal, organizational, community and policy levels. We conducted semi-structured interviews with pregnant women and new mothers (<i>n</i> = 70) and family members (<i>n</i> = 11), four focus group discussions with 35 women, and in-depth interviews with healthcare providers (HCPs, <i>n</i> = 26) and policymakers (<i>n</i> = 16). A majority (67%) of women were not included in decisions regarding their own pregnancy-related healthcare, which were typically made by other family members, such as husbands and mothers-in-law. HCPs, including community workers, were most influential in maternal vaccination decision-making, followed by family members. Although national guidelines were the next most important influencer, policymakers tended to underestimate communities' trust in and reliance on these guidelines. Traditional media are considered more trustworthy and influential than social media. Trust in HCPs and long-standing community use and experience with tetanus vaccines promoted what may be characterized as passive acceptance as they were given as a matter of course at antenatal appointments. Use of a social ecological framework indicates that many influences beyond individual-level factors influence maternal vaccine acceptance in developing settings. Clear government priority and policy along with engagement with families, communities and various types of HCPs are likely to be critical in maximizing acceptance of newer maternal vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2506849"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217364","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}
Dania Comparcini, Giancarlo Cicolini, Melania Totaro, Letizia Governatori, Francesco Pastore, Daniela Miniscalco, Maria Elena Flacco, Eustachio Cuscianna, Silvio Tafuri, Valentina Simonetti
{"title":"Influenza vaccination hesitancy and related factors among pregnant and breastfeeding women: A cross-sectional study.","authors":"Dania Comparcini, Giancarlo Cicolini, Melania Totaro, Letizia Governatori, Francesco Pastore, Daniela Miniscalco, Maria Elena Flacco, Eustachio Cuscianna, Silvio Tafuri, Valentina Simonetti","doi":"10.1080/21645515.2025.2450858","DOIUrl":"10.1080/21645515.2025.2450858","url":null,"abstract":"<p><p>Achieving safe influenza vaccination coverage among pregnant and breastfeeding women is a global health goal due to the potential risks of serious influenza for both mother and child. However, vaccine hesitancy remains a significant barrier to vaccination uptake. Since anxiety represents a determinant in vaccine decision-making, this study aimed to assess influenza vaccination hesitancy and anxiety levels in this population and to explore the association between women's characteristics, their reluctance, and anxiety levels. A multicentre, cross-sectional study was conducted between February and June 2022 using structured phone interviews to assess: (1) socio-demographics and clinical history; (2) anti-flu vaccination status, previous anti-flu vaccination, and Sars-CoV-2 infection history; (3) insights into influenza vaccination during pregnancy; (4) attitudes toward anti-flu vaccination, using the Vaccination Attitudes Examination (VAX) Scale; (5) anxiety levels, measured by the Self-Rating Anxiety Scale (SAS). Among the 387 participants, 22.8% were already vaccinated or expressed willingness to be vaccinated against influenza, and 54% had an anxiety disorder. While anxiety was not significantly associated with vaccine hesitancy, ongoing pregnancy emerged as an independent predictor of anxiety. Higher educational levels, ongoing pregnancy, already being vaccinated or willingness to get vaccinated, and being employed were associated with reduced vaccine hesitancy, while prior SARS-CoV-2 infection with increased hesitancy. Fear of unpredictable events and lack of healthcare professionals' recommendations emerged as reasons for vaccine reluctance. Given the low coverage rates, these findings highlight the need for health services to enhance vaccination efforts and provide clear recommendations to counter misinformation and ensure accurate vaccine safety information.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2450858"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985146","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}
Mengdi Ji, Zhuoying Huang, Han Yan, Jia Ren, Abram L Wagner, Xiaodong Sun, Matthew L Boulton
{"title":"HPV vaccination coverage, hesitancy, and barriers: Insights from a serial cross-sectional study in Shanghai, China (2019-2024).","authors":"Mengdi Ji, Zhuoying Huang, Han Yan, Jia Ren, Abram L Wagner, Xiaodong Sun, Matthew L Boulton","doi":"10.1080/21645515.2025.2513707","DOIUrl":"10.1080/21645515.2025.2513707","url":null,"abstract":"<p><p>Cervical cancer is the fourth most common cancer among women globally and a significant public health challenge in China, which accounts for nearly 18% of global cervical cancer cases. The HPV vaccine is a proven intervention for preventing high-risk HPV infections and associated cancers. This serial cross-sectional study conducted in Shanghai, China, in 2019 and 2024 analyzed changes in HPV vaccination rates and vaccine hesitancy. Multivariable logistic regression was used to assess the associations between HPV vaccination, general vaccine hesitancy, and HPV-specific vaccine hesitancy, adjusting for sociodemographic factors. The Population Attributable Fraction (PAF) quantified the proportion of non-vaccination attributable to these factors. In 2019 and 2024, two waves of data were collected from 1,037 and 1,450 parents, respectively. Results showed an increase in HPV vaccination from 6% to 30% during the study period, primarily among women aged 18 and older, while coverage among the WHO target group (girls aged 9-14) remained low at 8%. Parents with HPV-specific vaccine hesitancy were 75% less likely to vaccinate their daughters (OR = 0.25, 95% CI: 0.11-0.56), while general vaccine hesitancy reduced vaccination likelihood by 94% (OR = 0.06, 95% CI: 0.00-0.89). PAF analysis indicated that HPV-specific vaccine hesitancy contributed to 24% of non-vaccination cases, higher than general vaccine hesitancy (10%). These findings highlight the critical need for targeted interventions addressing HPV-specific barriers, improving education about vaccination timing and options, and reducing logistical obstacles to align with global cervical cancer elimination goals.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2513707"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12153397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259234","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}
Char Leung, Li Su, Aleksandra Zdanowicz, Lottie Collins, Ana Cristina Simões E Silva
{"title":"The effect of SARS-CoV-2 and influenza vaccination on endemic coronavirus-related mortality: A retrospective cohort study in Brazil.","authors":"Char Leung, Li Su, Aleksandra Zdanowicz, Lottie Collins, Ana Cristina Simões E Silva","doi":"10.1080/21645515.2025.2516314","DOIUrl":"10.1080/21645515.2025.2516314","url":null,"abstract":"<p><p>Endemic coronaviruses (eCoVs) cause the common cold in humans, particularly affecting children, the elderly, and individuals with comorbidities, who are prone to infection-related hospitalization. While vaccination remains the most effective preventative strategy against infections, vaccines against eCoVs are not available. This study investigates the association between SARS-CoV-2 and influenza vaccination and reduced eCoV-related mortality risk. Data from Brazil's nationwide hospital database included patients PCR-positive for one of four eCoV strains, with known admission and clinical endpoint dates, and either vaccinated against SARS-CoV-2 and/or influenza or unvaccinated. Cox regression assessed the vaccines' effectiveness in reducing 90-day in-hospital all-cause mortality. Of 4,283,391 registered cases, 2,636 were eCoV infections. Influenza vaccination, primarily inactivated formulations, was associated with a 39% lower mortality hazard. Conversely, SARS-CoV-2 vaccination showed no significant mortality reduction. This disparity may stem from SARS-CoV-2 vaccines targeting the spike protein, which differs markedly from eCoV spike proteins, limiting cross-protection. In contrast, inactivated influenza vaccines may reduce eCoV mortality through trained innate immunity and cross-reactive cellular responses, offering broader protective effects against these viruses.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2516314"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160596/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267743","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}
Ariel Bardach, Jamile Ballivian, Ângela Maria Bagattini, Michelle Quarti Machado da Rosa, Max Moura de Oliveira, Jorge A Gomez, Agustín Casarini
{"title":"Modeling the herpes zoster disease burden and its potential health impact on older adults >50 years of age in Brazil.","authors":"Ariel Bardach, Jamile Ballivian, Ângela Maria Bagattini, Michelle Quarti Machado da Rosa, Max Moura de Oliveira, Jorge A Gomez, Agustín Casarini","doi":"10.1080/21645515.2025.2520066","DOIUrl":"10.1080/21645515.2025.2520066","url":null,"abstract":"<p><p>In Brazil, as the older population has grown at a very rapid pace (by 57.4% over 2010), the number of herpes zoster (HZ) infections is expected to increase. As the Brazilian healthcare system constitutes a complex combination of public-private financing, estimating the true impact of HZ is challenging. The objective was to ascertain the disease burden of HZ and estimate its attributable cost in older adults aged ≥50 y who are users of public and private health services. Disease burden was estimated based on the ZOster ecoNomic Analysis model using Brazil-specific inputs, and any information gap was addressed by the Delphi Panel. The incidence estimates were multiplied by the cost per intervention to calculate the economic burden of the disease. In the absence of HZ vaccination, older adults ≥50 y are projected to experience 359,797 and 23,917 cases of HZ and post-herpetic neuralgia (PHN), with frequent and severe outcomes in the advanced age groups. The estimated mean cost of treatment per patient for HZ and PHN was ~7X and 16X more in the ANS population compared with the SUS. The number of hospitalizations (1339-1424) and median length of stay (4-5 d) were comparable between ANS and SUS. Hospitalization increased the treatment cost >10X (ANS: R$12459.67 -16,343.07; SUS: R$357.93 to 525.08). HZ imposes a substantial economic burden on the healthcare system due to high direct medical (R$357.36 million) and indirect costs (R$440.82 million). These results hold valuable insights for healthcare providers, insurers, and policymakers offering a comprehensive overview of the economic impact of HZ while implementing strategies for prevention of disease.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2520066"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12243895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144592783","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":"Bibliometric analysis of global research hotspots in ovarian cancer immunotherapy from 2014 to 2024 using CiteSpace.","authors":"Zhuo Zhang, Datian Fu, Yingdong Cao","doi":"10.1080/21645515.2025.2530288","DOIUrl":"10.1080/21645515.2025.2530288","url":null,"abstract":"<p><p>Bibliometric analysis has been employed to systematically evaluate the research landscape and emerging trends in ovarian cancer immunotherapy over the past decade (2014-2024). A bibliometric analysis of 3,100 publications (including reviews articles and articles) on immunotherapeutic interventions for ovarian malignancies was conducted using the Web of Science Core Collection (2014-2024). Temporal publication trends, institutional collaboration networks, and emerging research foci were systematically examined via CiteSpace software. A total of 3381 articles on ovarian cancer immunotherapy were initially identified, with 3100 records meeting the inclusion criteria for final analysis. The United States (<i>n</i> = 1,076) to become the major contributors of this field, with the University of Texas System (<i>n</i> = 131) being the most prolific institution. Among individual researchers, Odunsi, Kunle (<i>n</i> = 32) were the most extensively published authors. The most frequently cited reference was Matulonis UA (2019), with 235 citations. Co-citation cluster analysis revealed seven major research themes: expression, parp inhibitors, cancer immunotherapy, endometrial cancer, ovarian cancer, tumor associated antigens, chimeric antigen receptor. Parp inhibitors, tumor-associated antigens, and CAR-based therapies constituting critical themes for ovarian cancer research. Keyword burst detection identified emerging foci: dendritic cell, adoptive cell transfer, and regulatory T cell. These approaches offer promise for countering the TME characteristic of ovarian cancer, thereby enabling enhanced therapeutic efficacy. Prominent universities and developed nations form the finest alliances for research on immunotherapy for ovarian cancer. Three core research clusters are identified: dendritic cell-based therapies, adoptive immunotherapy, and tumor-infiltrating lymphocyte applications. These findings delineate the field's evolving trajectory and offer strategic directions for future investigations, emphasizing translational potential and multidisciplinary integration.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2530288"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12243898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144602052","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":"A second-generation, self-amplifying COVID-19 Vaccine: World's first approval and distribution in the Japanese market with vaccine hesitancy.","authors":"Toshio Naito","doi":"10.1080/21645515.2025.2530291","DOIUrl":"10.1080/21645515.2025.2530291","url":null,"abstract":"<p><p>The mRNA vaccine is a milestone in immunotherapeutics, as symbolized by the 2023 Nobel Prize for Physiology or Medicine awarded to Drs. Karikó and Weissman. Whereas the conventional, \"first-generation\" mRNA vaccine was globally distributed to hundreds of millions of people to decrease COVID-19 prevalence, further advanced constructs have been pursued by researchers and pharmaceutical manufacturers. The key feature of the \"second-generation\" mRNA vaccine is a self-amplifying replicon that may allow a low dose to ensure durable immunogenicity. In clinical trials, ARCT-154 indeed showed effectiveness (magnitude, persistence, and breadth) superior to conventional mRNA vaccines, with similar or less frequent adverse responses, and acquired its world's first approval in November 2023 in Japan (brand name: KOSTAIVE manufactured by Meiji Seika Pharma, Tokyo, Japan) to prevent COVID-19 infection. Real-world distribution of KOSTAIVE was started in October 2024, and researchers are collecting data on its effectiveness and safety despite nonscientific, but persistent, antivaccine skepticism.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2530291"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585460","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":"Assessment of knowledge and attitudes about vaccination in a population of pregnant women and impact of a training program.","authors":"Aslınur Özkaya Parlakay, Bircan Kayaaslan, Gonca Türker Ergün, Burak Elmas, Vesile Türk, Mehtap Tuğba Dokumacı, Özlem Moraloğlu Tekin","doi":"10.1080/21645515.2025.2521187","DOIUrl":"10.1080/21645515.2025.2521187","url":null,"abstract":"<p><p>Vaccination during pregnancy is vital for protecting both maternal and fetal health. A single-center, observational study was conducted with pregnant women attending the antenatal pregnancy school at Ankara City Hospital to assess the effect of maternal immunization training on pregnant women's knowledge and beliefs about vaccines through pre- and post-training evaluations. Participants completed a 26-item, 3-point Likert questionnaire both before and after a 30-minute training session led by specialist physicians. Changes in response rates for each statement were analyzed. Among 583 enrolled women, 308 completed both questionnaires and were included in the analysis. The median age was 28 years, and 90.6% had at least a high school education. The median gestational age was 34 weeks (range: 8-41), with 79.1% in the third trimester, and 49% were primigravida. Vaccination rates during the current pregnancy was reported by 66.6%, with Td (57.8%) as the most common vaccine, followed by Tdap (11.7%), COVID-19 (3.9%), and influenza (1.6%). Healthcare workers were the primary (92.2%) and most trusted (97.4%) source of vaccine information. Significant changes were observed in 23 of 26 post-training questionnaire statements. The most noticeable increase was related to awareness regarding pertussis and influenza vaccines during pregnancy. Concerns about vaccine-related harm during pregnancy also declined. However, general opposition to vaccination remained unchanged. In conclusion, providing education on immunization to pregnant women can improve vaccine knowledge and dispel misconceptions, offering public health benefits. Integrating these educational sessions into routine antenatal care may improve vaccination rates.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2521187"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144486768","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}
Thales A Campelo, Natália S Oliveira, Pedro F N Souza, Denis F G de-Oliveira, Cristiane C Frota, Paulo R Z Antas
{"title":"Unleashing the power of the BCG vaccine in modulating viral immunity through heterologous protection: A scoping review.","authors":"Thales A Campelo, Natália S Oliveira, Pedro F N Souza, Denis F G de-Oliveira, Cristiane C Frota, Paulo R Z Antas","doi":"10.1080/21645515.2025.2521190","DOIUrl":"10.1080/21645515.2025.2521190","url":null,"abstract":"<p><p>The Bacillus Calmette-Guérin (BCG) vaccine, used against tuberculosis for a century, shows promise in protecting against viral infections through trained/innate immunity. This review maps clinical and preclinical studies on both parental (WT) and recombinant BCG (rBCG) against 17 common viruses. From 68 studies, BCG strains were found to enhance innate immune responses by reprogramming myeloid cells, leading to stronger responses to related infections. Sixteen rBCG candidates expressed viral antigens, activating CD4+ and CD8+ T cells, and stimulating antibody production specific to the viral antigens. However, challenges like genetic stability and varied efficacy among BCG strains remain. The review highlights the potential of BCG, especially rBCG, as a multivalent vaccine platform for immunization campaigns, with significant public health implications. More translational studies and clinical trials are needed to confirm these findings.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2521190"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561677","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 9-valent human papillomavirus vaccine (GARDASIL® 9) reported to the Vaccine Adverse Event Reporting System (VAERS), 2015-2024.","authors":"Qiong Liu, Guojun Liang, Yang Song","doi":"10.1080/21645515.2025.2530831","DOIUrl":"10.1080/21645515.2025.2530831","url":null,"abstract":"<p><p>GARDASIL 9, a 9-valent HPV vaccine approved in 2014, is widely administered for the prevention of HPV-related malignancies. Although clinical trials demonstrated a favorable safety profile, rare or delayed-onset adverse events may not be captured pre-licensure. Post-marketing surveillance using VAERS offers a complementary approach for signal detection and safety monitoring. We conducted a retrospective pharmacovigilance analysis of VAERS reports following GARDASIL 9 administration from January 1, 2015 to December 31, 2024. Adverse events were encoded using MedDRA v26.0 and categorized by System Organ Class. Disproportionality analyses using four independent algorithms (ROR, PRR, IC, EBGM) were applied to identify positive safety signals. Subgroup assessments included serious reports, death reports, and reports in pregnant individuals. Among reported events, most were non-serious and consistent with known reactogenicity patterns, including syncope, headache, and injection site reactions. However, signals were also detected for certain events not listed in product labeling, including postural orthostatic tachycardia syndrome, eye movement disorder, autoimmune thyroiditis, and posture abnormality. In 57 death reports, neurological terms showed signal elevation but lacked consistent etiologic patterns. No positive signals were detected in the 18 pregnancy-associated reports. This VAERS-based analysis supports the established safety of GARDASIL 9 while highlighting rare signals that warrant further investigation. Given the limitations of passive surveillance, integration with active monitoring systems is essential to refine safety profiles and support ongoing public health vaccination efforts.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2530831"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12269663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638548","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}