Expert Review of VaccinesPub Date : 2026-12-31Epub Date: 2026-07-26DOI: 10.1080/14760584.2026.2708184
Alexandre Blake, James Humphreys, Kate Olson, Toon Braeye, Izaak Van Evercooren, Christian Holm Hansen, Ida Rask Moustsen-Helms, Massimo Fabiani, Alberto Mateo-Urdiales, Jesús Castilla, Iván Martínez-Baz, Ausenda Machado, Andre Brito, Rickard Ljung, Nicklas Pihlström, Yohann Mansiaux, Nathalie Nicolay, Susana Monge, Baltazar Nunes
{"title":"Adapted XBB.1.5 vaccine effectiveness against severe COVID-19 outcomes among immunocompromised persons in 2023-24 in six European countries: a VEBIS-EHR network study.","authors":"Alexandre Blake, James Humphreys, Kate Olson, Toon Braeye, Izaak Van Evercooren, Christian Holm Hansen, Ida Rask Moustsen-Helms, Massimo Fabiani, Alberto Mateo-Urdiales, Jesús Castilla, Iván Martínez-Baz, Ausenda Machado, Andre Brito, Rickard Ljung, Nicklas Pihlström, Yohann Mansiaux, Nathalie Nicolay, Susana Monge, Baltazar Nunes","doi":"10.1080/14760584.2026.2708184","DOIUrl":"10.1080/14760584.2026.2708184","url":null,"abstract":"<p><strong>Background: </strong>We estimated the XBB.1.5 vaccine effectiveness (VE) against COVID-19 hospitalization and death in Belgium, Denmark, Italy, Portugal, Spain (Navarre), and Sweden following the 2023-24 fall vaccination campaign among immunocompromised persons (ICPs).</p><p><strong>Research design and methods: </strong>We conducted a multi-country retrospective cohort study using electronic health records. Study sites identified ICPs aged ≥18 years through a common set of immunocompromising conditions and follow-up started the first day of the 2023 vaccination campaign until 12 months later. VE was calculated by time since vaccination (14-59, 60-119, 120-179, 180-365 days after vaccination) for ICPs by pooling study site level confounder adjusted hazard ratios (aHR) of vaccination, estimated with Cox proportional hazards regression models, using a random effect meta-analysis with VE = 100 × (1-pooled aHR).</p><p><strong>Results: </strong>The XBB.1.5 VE was 52% (95% confidence interval (CI): 41 to 60) and 75% (95%CI: 60 to 84) against hospitalization and death, respectively, 14-59 days after vaccination, and VE decreased with time since vaccination with no remaining protection at 180-365 days after vaccination.</p><p><strong>Conclusion: </strong>Adapted XBB.1.5 vaccine provided moderate protection within 120 days after vaccination against severe COVID-19 outcomes among ICPs aged ≥18 years during a period with BA.2.86/JN.1 replacing the XBB.1.5 variant.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"25 1","pages":"2708184"},"PeriodicalIF":5.6,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148591206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-31Epub Date: 2026-04-07DOI: 10.1080/14760584.2026.2653758
Min Yang, Lingling Wang, Xuwen Wang, Lu Zhou, Xu Yang, Jingfeng Jiang, Kun Yang, Qiujin Chen, Shixin Xiu, Yihan Lu
{"title":"Evaluation of varicella outbreak control following implementation of a two-dose free vaccination policy in Wuxi, China (2014-2024).","authors":"Min Yang, Lingling Wang, Xuwen Wang, Lu Zhou, Xu Yang, Jingfeng Jiang, Kun Yang, Qiujin Chen, Shixin Xiu, Yihan Lu","doi":"10.1080/14760584.2026.2653758","DOIUrl":"10.1080/14760584.2026.2653758","url":null,"abstract":"<p><strong>Background: </strong>Varicella is a common vaccine-preventable disease in China, with frequent outbreaks in schools and communities. In late 2018, Wuxi implemented a free two-dose varicella vaccination policy. This study evaluated its epidemiological impact.</p><p><strong>Research design and methods: </strong>We analyzed outbreak data from Wuxi during 2014-2024. Main outcomes included outbreaks, cases, and outbreak duration. Interrupted time series and ARIMA models were used to evaluate temporal trends. Fixed-effects regression examined the association between vaccination coverage and outbreak indicators. Spatial analysis identified clustering patterns before and after policy.</p><p><strong>Results: </strong>After policy implementation (2019-2024), outbreaks decreased by about 56% and cases decreased by about 60%. Annual percent change shifted from strongly positive before the policy (APC > 140%, <i>p</i> < 0.05) to negative after the policy (APC < -30%, <i>p</i> < 0.05). Each 1% increase in two-dose coverage was associated with reductions of 0.82 outbreaks (<i>p</i> < 0.001), 21.67 cases (<i>p</i> < 0.001), and 2.55 days in duration (<i>p</i> < 0.05). Spatial clustering weakened over time.</p><p><strong>Conclusion: </strong>The free two-dose vaccination policy was associated with substantial reductions in varicella outbreaks in Wuxi. Sustaining high two-dose coverage remains important. Interpretation should consider the ecological design, lack of individual-level vaccination data, and potential COVID-19-related confounding.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2653758"},"PeriodicalIF":5.6,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147573055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-04-01DOI: 10.1080/14760584.2026.2653749
Laith J Abu-Raddad, Hiam Chemaitelly
{"title":"Beyond aggregate estimates: stratified self-controlled case series analyses and insights into COVID-19 vaccine safety.","authors":"Laith J Abu-Raddad, Hiam Chemaitelly","doi":"10.1080/14760584.2026.2653749","DOIUrl":"10.1080/14760584.2026.2653749","url":null,"abstract":"","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2653749"},"PeriodicalIF":4.8,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-09-16DOI: 10.1080/14760584.2026.2732508
Mahan Ghafari, Oliver J Watson, Stefan Dascalu, Sandra Hsu Hnin Mon, Lucie Abeler-Dörner, Mohammad Saeid Rezaee-Zavareh, Caitlin Pley, Shahram Kordasti, Kaja Abbas, Kaveh Madani, Jasmina Panovska-Griffiths
{"title":"Global vaccine readiness: equity-by-design in pandemic preparedness and response.","authors":"Mahan Ghafari, Oliver J Watson, Stefan Dascalu, Sandra Hsu Hnin Mon, Lucie Abeler-Dörner, Mohammad Saeid Rezaee-Zavareh, Caitlin Pley, Shahram Kordasti, Kaja Abbas, Kaveh Madani, Jasmina Panovska-Griffiths","doi":"10.1080/14760584.2026.2732508","DOIUrl":"https://doi.org/10.1080/14760584.2026.2732508","url":null,"abstract":"<p><strong>Introduction: </strong>COVID-19 showed that rapid vaccine development and roll-out, while lifesaving, can still yield large, avoidable harms when equity is not considered from the outset. Disparities in vaccine timing and coverage, especially in low-resource settings, amplified health and economic burdens, highlighting the need for preparedness frameworks that combine speed with fairness.</p><p><strong>Areas covered: </strong>We synthesize evidence from literature and policy reports regarding global vaccine roll-out, focusing on avertable mortality under alternative sharing scenarios, procurement design, pooled mechanisms such as COVAX, and the role of distributed manufacturing and delivery capacity. We also examine how transparent data-sharing, effective public communication, genomic surveillance, adaptive trial designs, and modeling hubs can support more responsive and equitable vaccine deployment. Across six reflection points, we translate these lessons into practical priorities for future pandemic readiness, including strengthening healthcare infrastructure, equitable procurement, data transparency, and safeguarding public health decision-making from political and commercial distortion.</p><p><strong>Expert opinion: </strong>We argue that equity-by-design is essential if vaccine innovation is to deliver equitable public health impact. This requires geographically distributed manufacturing, transparency, equity-conditioned advance purchase agreements, and pre-agreed, epidemiology-triggered allocation of vaccines. We recommend institutionalizing disaggregated reporting, standardized data-sharing, greater pathogen genomic sequencing capacity, and communication strategies that support public health protection while countering misinformation.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"25 1","pages":"2732508"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2025-12-25DOI: 10.1080/14760584.2025.2607482
Raphael Simon, Erik Lamberth, James H Stark, Julie M Skinner
{"title":"A human Lyme disease vaccine: two steps forward on the path to prevention.","authors":"Raphael Simon, Erik Lamberth, James H Stark, Julie M Skinner","doi":"10.1080/14760584.2025.2607482","DOIUrl":"10.1080/14760584.2025.2607482","url":null,"abstract":"<p><strong>Introduction: </strong>Lyme disease is caused by the tick-borne spirochete pathogen <i>Borrelia burgdorferi</i> sensu lato (s.l.). Outer surface protein A (OspA) is expressed by <i>B.</i> <i>burgdorferi</i> s.l. while in the tick and antibodies against OspA introduced into the tick with the bloodmeal can prevent transmission. OspA-based vaccines have been validated in people, however, there are currently no available human Lyme disease vaccines. Hexavalent OspA vaccine VLA15 is designed to cover the dominant <i>B.</i> <i>burgdorferi</i> s.l. genospecies causing disease in North America and Europe and is currently the most advanced candidate human Lyme disease vaccine in clinical development.</p><p><strong>Areas covered: </strong>A historical retrospective of the discovery and evolving burden of Lyme disease is covered, as well as relevant aspects of the vector biology, preclinical research underpinning development of VLA15, and its clinical development to date.</p><p><strong>Expert opinion: </strong>Lyme disease has expanded over the past two decades in both incidence and geographic footprint and is anticipated to continue to increase in the future due to changing climate and human encroachment into wildlife areas. VLA15 is currently in the last stage of clinical development, and if found to be safe and efficacious, may offer an important prophylactic modality for prevention of Lyme disease.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2607482"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-04-01DOI: 10.1080/14760584.2026.2653756
Robert A Bednarczyk
{"title":"Suboptimal vaccine uptake and vaccine hesitancy in the United States: current challenges and future directions.","authors":"Robert A Bednarczyk","doi":"10.1080/14760584.2026.2653756","DOIUrl":"10.1080/14760584.2026.2653756","url":null,"abstract":"<p><strong>Introduction: </strong>Vaccination is an important tool to prevent infectious disease morbidity and mortality. Increased vaccine hesitancy and declining vaccination are contributing to larger infectious disease outbreaks. This review presents the current state of research and knowledge on vaccine hesitancy, focused on the United States (US).</p><p><strong>Areas covered: </strong>This review covers the history of vaccination and vaccine hesitancy, recent and ongoing outbreaks, and updates in understanding of vaccine hesitancy and use of new psychology-based tools to address it. Articles for inclusion were sourced from extant understanding of the vaccine hesitancy literature as well as PubMed searches to ensure appropriate context.</p><p><strong>Expert opinion: </strong>Population-level outreach and effective communication about vaccines is a central component to addressing vaccine hesitancy and restoring and maintaining trust in the vaccination system. With new ways of understanding vaccine hesitancy rooted in the psychology of decision-making, there is a need for research into outreach, message development, and implementation, within the information and social media environment that allows even faster dissemination of mis- and dis-information. Balancing the rigor of communications and implementation research with the need for timely communications is a pressing challenge to be faced by public health and medical professionals when addressing vaccine hesitancy.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2653756"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vaccine hesitancy among 0-6-year-olds' guardians in Chongqing: a cross-sectional survey revealing how immunization program managers' robust comprehensive capacity for adverse events following immunization (AEFI) management mitigates hesitancy.","authors":"Binyue Xu, Qing Wang, Jiawei Xu, Jianqiao Li, Ningpei Bai, Chunbei Zhou","doi":"10.1080/14760584.2026.2640140","DOIUrl":"10.1080/14760584.2026.2640140","url":null,"abstract":"<p><strong>Background: </strong>Vaccine hesitancy hinders optimal immunization coverage with fear of adverse events following immunization (AEFI) as a key driver. This study examines how robust district-level AEFI management capacity alleviates vaccine hesitancy among guardians of 0-6-year-olds in Chongqing, China.</p><p><strong>Research design and methods: </strong>A cross-sectional survey was conducted from January to March 2023. Guardians were recruited via multistage stratified sampling. Two-level multivariate modeling and structural equation modeling (SEM) were employed to explore direct and indirect effects of AEFI management capacity on hesitancy.</p><p><strong>Results: </strong>Among 2664 valid samples, the mean hesitancy score was 21.9 ± 4.5, with 19.5% self-reporting hesitancy. AEFI incident response capability (β = -1.087, 95% CI: -2.053~-0.121), approval of district AEFI committees (β = -1.202, 95% CI: -1.839~-0.565) and higher vaccination knowledge (β = -0.377, 95% CI: -0.571~-0.183) were negatively correlated with hesitancy. SEM further demonstrated that district-level AEFI management capacity indirectly decreases the guardians' hesitancy by improving their approval of AEFI committees (β = 0.183, 95% CI: 0.093 ~ 0.284).</p><p><strong>Conclusions: </strong>Robust district AEFI management and higher vaccination knowledge alleviate guardians' hesitancy. Targeted interventions can boost trust and coverage. These findings provide actionable insights for refining immunization policies and practice in China and other countries facing similar challenges.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2640140"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147325173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-06-21DOI: 10.1080/14760584.2026.2689612
Rachata Charoenwisedsil, Saranath Lawpoolsri, Pinyo Rattanaumpawan, Narisa Ruenroengbun, Gerard T Flaherty, Daniel M Parker, Thundon Ngamprasertchai
{"title":"Barriers to dengue vaccine uptake in international travelers: a mixed-methods study.","authors":"Rachata Charoenwisedsil, Saranath Lawpoolsri, Pinyo Rattanaumpawan, Narisa Ruenroengbun, Gerard T Flaherty, Daniel M Parker, Thundon Ngamprasertchai","doi":"10.1080/14760584.2026.2689612","DOIUrl":"10.1080/14760584.2026.2689612","url":null,"abstract":"<p><strong>Background: </strong>Dengue poses a growing threat to international travelers, yet vaccine uptake remains limited due to inconsistent guidelines and psychological barriers. This study provides barriers and determinants of hesitancy, which may guide strategies once global dengue vaccination guidelines for travelers are established.</p><p><strong>Research design and methods: </strong>We conducted an explanatory sequential mixed-methods study from May 2024 to March 2025 in Bangkok, Thailand, assessing vaccine hesitancy among 429 international travelers using the 5C model and thematic analysis of interviews.</p><p><strong>Results: </strong>The prevalence of dengue vaccine hesitancy was higher than previous literature. Dengue vaccine acceptance was 36.8%, with non-religious affiliation (adjusted odds ratio [aOR]: 4.89; 95% CI: 2.55-9.38), higher confidence, and lower perceived constraints significantly associated with acceptance. Non-acceptors reported significantly higher levels of complacency and constraints, and lower collective responsibility scores (all <i>p</i> < 0.001). Travelers often underestimated dengue risk and cited logistical challenges and vaccine accessibility as barriers. Trust in healthcare providers, especially from endemic regions, influenced decisions, while collective responsibility was less relevant.</p><p><strong>Conclusions: </strong>High dengue vaccine hesitancy highlights the need for healthcare providers to enhance vaccine confidence through evidence-based counseling and address complacency by correcting risk misconception. Improving vaccine accessibility and aligning schedules with travel plans may reduce constraints and vaccine messaging may be more effective by prioritizing individual-level benefit to maximize impact once global guidelines are established.</p><p><strong>Clinical trial registration: </strong>The study was registered with the Clinical Trials.gov (Clinical trial.gov NCT06418854).</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"2689612"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148249832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-08-10DOI: 10.1080/14760584.2026.2708196
Heather VanSeggelen, Daniela M Ferreira, Richard Malley, Jose Yuste, Christoph J Blohmke, Cathy Srokowski, David O Willer, Shite Sebastian
{"title":"Cellular immunity to <i>Streptococcus pneumoniae</i>: implications for vaccine-mediated prevention.","authors":"Heather VanSeggelen, Daniela M Ferreira, Richard Malley, Jose Yuste, Christoph J Blohmke, Cathy Srokowski, David O Willer, Shite Sebastian","doi":"10.1080/14760584.2026.2708196","DOIUrl":"10.1080/14760584.2026.2708196","url":null,"abstract":"<p><strong>Introduction: </strong><i>Streptococcus pneumoniae</i> asymptomatically colonizes the nasopharynx but can also cause mucosal infections or invasive pneumococcal disease. Despite the significant positive impact of pneumococcal conjugate vaccines, the burden of pneumococcal disease persists, reflecting the inherent limitations of a strategy that elicits serotype-dependent humoral immunity against a pathogen with > 100 known serotypes.</p><p><strong>Areas covered: </strong>Animal model data suggest that in addition to anti-capsular antibodies, CD4+ T-cell responses (including Th1 and Th17) and CD8+ T cells may also contribute to protection against pneumococcal colonization and disease. However, the contribution of cellular immune responses against <i>S. pneumoniae</i> in humans has not been fully elucidated, with human challenge models suggesting a potential role for CD8+ T cells, CD4+ Th17 cells, and tissue-resident memory T cells in protection. We summarize here the evidence on cellular immune responses elicited by exposure to <i>S. pneumoniae</i> and provide an overview of the cellular immune responses induced by candidate pneumococcal vaccines (whole-cell vaccines, protein-based vaccines, and vaccines using MAPS technology).</p><p><strong>Expert opinion: </strong>Improving protection against <i>S. pneumoniae</i> will require future pneumococcal vaccines to induce a broad, multipronged immune response. This strategy implies identifying new immunological benchmarks beyond capsular antibodies. Therefore, defining protective cellular responses represents a critical research priority.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"25 1","pages":"2708196"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148705410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expert Review of VaccinesPub Date : 2026-12-01Epub Date: 2026-08-27DOI: 10.1080/14760584.2026.2720955
Seol Jang, Sung-Inn Pyo, Eun Jin Kim, Woojoo Lee, Soon-Sun Kwon
{"title":"Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.","authors":"Seol Jang, Sung-Inn Pyo, Eun Jin Kim, Woojoo Lee, Soon-Sun Kwon","doi":"10.1080/14760584.2026.2720955","DOIUrl":"10.1080/14760584.2026.2720955","url":null,"abstract":"<p><strong>Introduction: </strong>Whether BNT162b2 (Pfizer-BioNTech) vaccination increases stroke risk remains a public health concern. This is the first meta-analysis to synthesize self-controlled case series (SCCS)-derived stroke risk estimates specifically for BNT162b2 vaccination.</p><p><strong>Methods: </strong>PubMed and Embase were searched from inception through 9 May 2026, following PRISMA 2020 guidelines. Eight eligible SCCS studies were pooled using a random-effects model with restricted maximum likelihood (REML) estimation and the Knapp-Hartung adjustment.</p><p><strong>Results: </strong>Eight studies across six countries encompassing several million vaccinated individuals were included. The pooled incidence rate ratio (IRR) was 0.967 (95% CI 0.892-1.049; I<sup>2</sup> = 69.2%), indicating no statistically significant increase in stroke risk. Subgroup analyses showed no evidence of effect modification across continent, risk-window length, dose category, SCCS variant, or age group.</p><p><strong>Conclusions: </strong>These findings provide no evidence of increased short-term stroke risk following BNT162b2 vaccination at the population level. The observed heterogeneity appeared to be partly driven by methodological differences rather than true biological variation in vaccine effect.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"25 1","pages":"2720955"},"PeriodicalIF":5.6,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148838905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}