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Corrigendum to “I want to chat with a person”: a qualitative longitudinal cohort study in England exploring drivers of sub-optimal childhood vaccination uptake” [Vaccine 62 (2025) 127462] “我想和一个人聊天”的勘误表:英格兰的一项定性纵向队列研究,探索儿童疫苗接种次优的驱动因素”[疫苗62 (2025)127462]
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-22 DOI: 10.1016/j.vaccine.2025.127522
Georgia Chisnall , Louise Letley , Sandra Mounier-Jack , Helen Bedford , Tracey Chantler
{"title":"Corrigendum to “I want to chat with a person”: a qualitative longitudinal cohort study in England exploring drivers of sub-optimal childhood vaccination uptake” [Vaccine 62 (2025) 127462]","authors":"Georgia Chisnall , Louise Letley , Sandra Mounier-Jack , Helen Bedford , Tracey Chantler","doi":"10.1016/j.vaccine.2025.127522","DOIUrl":"10.1016/j.vaccine.2025.127522","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127522"},"PeriodicalIF":4.5,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144680312","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}
引用次数: 0
A mRNA vaccine encoding for a 60-mer Nipah virus G glycoprotein nanoparticle elicits a robust neutralizing antibodies response against the Nipah virus 一种编码60粒尼帕病毒G糖蛋白纳米颗粒的mRNA疫苗引发了针对尼帕病毒的强大中和抗体反应
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-22 DOI: 10.1016/j.vaccine.2025.127530
Pascal Brandys , César G. Albariño , Shilpi Jain , Irena Merenkova , Nicholas J. Schork , Aihua Deng , Martine Valière , Jens Herold
{"title":"A mRNA vaccine encoding for a 60-mer Nipah virus G glycoprotein nanoparticle elicits a robust neutralizing antibodies response against the Nipah virus","authors":"Pascal Brandys ,&nbsp;César G. Albariño ,&nbsp;Shilpi Jain ,&nbsp;Irena Merenkova ,&nbsp;Nicholas J. Schork ,&nbsp;Aihua Deng ,&nbsp;Martine Valière ,&nbsp;Jens Herold","doi":"10.1016/j.vaccine.2025.127530","DOIUrl":"10.1016/j.vaccine.2025.127530","url":null,"abstract":"<div><div>The Nipah virus is a zoonotic pathogen causing encephalitis and acute respiratory illness in humans with very high fatality rates. Here we report a novel messenger RNA vaccine that directly encodes for a nanoparticle displaying 60 head domains of the Nipah virus G (NiV G) glycoprotein that acts as a highly effective antigen. A vaccine encoding for the NiV G nanoparticle elicits high antibody titers against NiV G and a robust neutralizing antibody response with a pseudotyped Nipah virus system. We ultimately find that the proposed mRNA NiV G nanoparticle (mRNA NiV G-NP) provides a flexible platform for the development of vaccines that will likely be of great value in combatting future Nipah virus outbreaks.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127530"},"PeriodicalIF":4.5,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144687051","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}
引用次数: 0
Validating community concerns of menstrual changes associated with COVID-19 vaccination using a self-controlled case series analysis of real-world data 通过对真实世界数据的自我控制病例系列分析,验证社区对COVID-19疫苗接种相关月经变化的担忧
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-21 DOI: 10.1016/j.vaccine.2025.127511
Aishwarya N. Shetty , Gonzalo Sepulveda Kattan , Muhammad Javed , Christopher Pearce , Jim P. Buttery , Hazel J. Clothier
{"title":"Validating community concerns of menstrual changes associated with COVID-19 vaccination using a self-controlled case series analysis of real-world data","authors":"Aishwarya N. Shetty ,&nbsp;Gonzalo Sepulveda Kattan ,&nbsp;Muhammad Javed ,&nbsp;Christopher Pearce ,&nbsp;Jim P. Buttery ,&nbsp;Hazel J. Clothier","doi":"10.1016/j.vaccine.2025.127511","DOIUrl":"10.1016/j.vaccine.2025.127511","url":null,"abstract":"<div><h3>Objectives</h3><div>Stories of menstrual changes occurring post COVID-19 vaccination have abounded, with many affected persons expressing frustration their concerns were not being heard. In an era where misinformation is rampant and can fuel vaccine hesitancy it is imperative to address and validate community concerns. We aimed to investigate evidence of increased menstrual disturbances associated with COVID-19 vaccination.</div></div><div><h3>Methods</h3><div>We adopted a two-pronged approach; firstly, scrutinising social-media for discussions on menstrual changes associated with COVID-19 vaccination using our deep learning framework VaxPulse. Secondly, we analysed a large de-identified Australian general practice dataset to validate any evidence of increased menstrual disturbance presentations for females aged 15–49 years post-COVID-19 vaccination from 1 January 2021 to 28 March 2023, stratified by vaccine platform (adenovirus vector, mRNA, or protein-subunit). We used a self-controlled case series (SCCS) analysis to determine the relative incidence (RI) with 95 % confidence interval (CI) at six weeks post-vaccination and monitored thereafter until a return to baseline for minimum 2 consecutive weeks.</div></div><div><h3>Results</h3><div>Examining Reddit and Twitter (now X) data, we identified 70,977 posts discussing menstrual cycle irregularities with two prominent peaks since the global COVID-19 vaccine rollout. The SCCS analysis demonstrated increased presentations with a menstrual disturbance diagnosis associated with mRNA COVID-19 vaccination (RI: 1.14, 95 %CI: 1.07, 1.22, <em>P</em> &lt; 0.001). The increase in presentations was still evident at 7 weeks but dissipated by 13 weeks post vaccination. (RI:1.03, 95 %CI: 0.91, 1.16, <em>P</em> = 0.20).</div></div><div><h3>Conclusion</h3><div>This study demonstrated a transient increase in menstrual change presentations for up to three months following COVID-19 mRNA vaccination. These findings affirm community concerns raised on social media and are important to ensure people who are vaccinated or are considering future vaccines feel heard, supported, and validated. Our analyses highlight the value of using large real-world datasets to gather reliable evidence for public health decision-making.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127511"},"PeriodicalIF":4.5,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144672032","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}
引用次数: 0
New adult and adolescent tuberculosis vaccines and Indonesia: policy planning and evidence, November 2024 新的成人和青少年结核病疫苗与印度尼西亚:政策规划和证据,2024年11月
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-21 DOI: 10.1016/j.vaccine.2025.127490
Mohammed Alfaqeeh , Sarah Ewart , Rodri Tanoto , Widyaretna Buenastuti , Ina Agustina Isturini , Prima Yosephine , Erlina Burhan , Ria C. Siagian , Sri Rezeki Hadinegoro , Diah Lenggogeni , Richard G. White , Auliya A. Suwantika , Tereza Kasaeva , Birgitte Giersing
{"title":"New adult and adolescent tuberculosis vaccines and Indonesia: policy planning and evidence, November 2024","authors":"Mohammed Alfaqeeh ,&nbsp;Sarah Ewart ,&nbsp;Rodri Tanoto ,&nbsp;Widyaretna Buenastuti ,&nbsp;Ina Agustina Isturini ,&nbsp;Prima Yosephine ,&nbsp;Erlina Burhan ,&nbsp;Ria C. Siagian ,&nbsp;Sri Rezeki Hadinegoro ,&nbsp;Diah Lenggogeni ,&nbsp;Richard G. White ,&nbsp;Auliya A. Suwantika ,&nbsp;Tereza Kasaeva ,&nbsp;Birgitte Giersing","doi":"10.1016/j.vaccine.2025.127490","DOIUrl":"10.1016/j.vaccine.2025.127490","url":null,"abstract":"<div><div>This report summarizes the proceedings of a policy and planning meeting convened in Indonesia, by the Ministry of Health and the World Health Organization, on potential new tuberculosis (TB) vaccines intended for adults and adolescents. Given that Indonesia bears the second highest TB burden globally, and that it is participating in the phase III efficacy study for one of the leading vaccine candidates that could be approved for use by 2028, the meeting aimed to discuss strategies and evidence needs that could accelerate vaccine introduction. The meeting, held in November 2024, was attended by Indonesian policymakers, researchers, health advocates and community representatives, alongside observers from immunization and TB programmes working at the global level, as well as donors. This report offers several key recommendations to ensure new TB vaccines for adults and adolescents are available, accessible and acceptable in Indonesia, as soon as possible after regulatory approval.</div><div>The vaccine implementation strategy is expected to be through a stratified, geographical approach, initiating in provinces with the highest disease and socio-economic burden. As such, improved data on disease, infection prevalence and acceptability within different age cohorts and populations are needed to inform national and sub-national (e.g., province or district level) health and economic impact modelling. Early studies on knowledge, attitudes and practices of new TB vaccines for adults and adolescents will help to engage community leaders and advocates and ensure effective, culturally acceptable communication to improve acceptability. Of greatest urgency, a national strategic plan for new TB vaccine introduction, including a roadmap of critical activities, responsible entities and a stakeholder engagement plan are needed.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127490"},"PeriodicalIF":4.5,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144672026","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}
引用次数: 0
Factors related to COVID-19 vaccine effectiveness perception in racially diverse adults in Canada 加拿大不同种族成年人对COVID-19疫苗有效性认知的相关因素
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-21 DOI: 10.1016/j.vaccine.2025.127498
Rose Darly Dalexis , Mwali Muray , Taddele Cherinet Kibret , Seyed Mohammad Mahdi Moshirian Farahi , Jude Mary Cénat
{"title":"Factors related to COVID-19 vaccine effectiveness perception in racially diverse adults in Canada","authors":"Rose Darly Dalexis ,&nbsp;Mwali Muray ,&nbsp;Taddele Cherinet Kibret ,&nbsp;Seyed Mohammad Mahdi Moshirian Farahi ,&nbsp;Jude Mary Cénat","doi":"10.1016/j.vaccine.2025.127498","DOIUrl":"10.1016/j.vaccine.2025.127498","url":null,"abstract":"<div><div>While disparities in COVID-19 vaccine confidence, mistrust, hesitancy, and uptake are well documented, the perception of vaccine efficacy remains understudied in Canada. This study investigates racial differences in COVID-19 vaccine efficacy perception and examines associated factors across Arab, Asian, Black, Indigenous, and White populations. A representative sample of 4220 participants (2358 women) aged 16 and older completed measures assessing perception of COVID-19 vaccine efficacy, conspiracy beliefs, health literacy, and racial discrimination in healthcare settings. Data were collected through a randomly selected online panel in October 2023. The overall mean vaccine efficacy perception score was 17.1 (SD = 4.5), with significant variation across racial groups (<em>F</em>(6, 4213) = 8.0, <em>p</em> &lt; .001). Asian participants (<em>M</em> = 18.4; <em>SD</em> = 3.1) reported higher scores compared to Arab (<em>M</em> = 17.0; <em>SD</em> = 4.3), Black (<em>M</em> = 17.2; <em>SD</em> = 4.3), Indigenous (<em>M</em> = 16.4; <em>SD</em> = 5.2), and White (<em>M</em> = 17.1; <em>SD</em> = 4.4) participants. The most important factors associated with vaccine efficacy perception were conspiracy beliefs (β = −0.32, <em>p</em> &lt; .001), health literacy (β = 0.07, <em>p</em> &lt; .001), and the number of vaccine doses in White individuals. Conspiracy beliefs (β = −0.19, <em>p</em> &lt; .001), higher education (β = 0.28, <em>p</em> &lt; .001), health literacy (β = 0.16, <em>p</em> &lt; .001), more vaccine doses (β = 1.61, <em>p</em> &lt; .001), and experiences of racial discrimination in healthcare prior to accounting for conspiracy beliefs (β = −0.10, <em>p</em> &lt; .05) were the most important factors for racialized individuals. This study highlights significant differences in COVID-19 vaccine efficacy perceptions across racial groups. The findings underscore the impact of factors such as conspiracy beliefs, health literacy, education level, age, and racial discrimination in healthcare on vaccine efficacy perceptions. Public health strategies should address misinformation, prioritize health literacy, and promote anti-racist practices in healthcare to improve vaccine confidence and acceptance.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127498"},"PeriodicalIF":4.5,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144680311","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}
引用次数: 0
Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study 无硫柳汞重组戊型肝炎疫苗的安全性和免疫原性:一项随机、双盲、主动对照研究
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127510
Junrong Li , Xiujuan Wang , Dengxiang Zhang , Fangqin Xie , Sumei Zhong , Xiaoshan Yu , Shasha Chen , Qinbiao Huang , Rui Wang , Qiufen Zhang , Dongjuan Zhang
{"title":"Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study","authors":"Junrong Li ,&nbsp;Xiujuan Wang ,&nbsp;Dengxiang Zhang ,&nbsp;Fangqin Xie ,&nbsp;Sumei Zhong ,&nbsp;Xiaoshan Yu ,&nbsp;Shasha Chen ,&nbsp;Qinbiao Huang ,&nbsp;Rui Wang ,&nbsp;Qiufen Zhang ,&nbsp;Dongjuan Zhang","doi":"10.1016/j.vaccine.2025.127510","DOIUrl":"10.1016/j.vaccine.2025.127510","url":null,"abstract":"<div><h3>Introduction</h3><div>The first recombinant hepatitis E vaccine (<em>Escherichia Coli</em>), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years. Innovax has developed a thiomersal-free formulation process change according to the requirement of <em>2020 Chinese Pharmacopoeia</em>. This study aimed to evaluate the safety and immunogenicity of the thiomersal-free hepatitis E vaccine compared with the licensed hepatitis E vaccine in people aged ≥16 years. Clinical Trial Registration: <span><span>NCT06564116</span><svg><path></path></svg></span>.</div></div><div><h3>Methods</h3><div>This was a single-center, randomized, double-blind, active-controlled study conducted in China. Eligible participants were randomly assigned in a 1:1 ratio to the thiomersal-free hepatitis E vaccine group (HEV-TF group) or the hepatitis E vaccine group (HEV group) stratified by sex and age. Each participant received three doses of the vaccine intramuscularly at 0, 1 and 6 months. Safety was evaluated based on adverse events (AEs) occurred within 30 days following each dose, serious adverse events (SAEs) and pregnancy events occurred during the study period. Immunogenicity was evaluated through quantification of anti-HEV IgG in serum samples collected at 0 and 7 months.</div></div><div><h3>Results</h3><div>A total of 612 eligible participants were enrolled and received at least 1 dose of vaccine. 558 participants were included in the per protocol set for immunogenicity. All participants seroconverted in both groups by month 7. The seroconversion rate difference was 0.00 % (95 % confidence interval [CI] -1.38 to 1.34). The geometric mean concentrations (GMCs) in HEV-TF group and HEV group were 16.57 U/mL and 18.47 U/mL, respectively. The GMC ratio was 0.90 (95 % CI 0.79 to 1.01). The overall AEs rates were similar between the groups (16.88 % vs. 12.50 %). Most of AEs were grade 1 or 2. No vaccine-related SAE occurred during the study period.</div></div><div><h3>Conclusions</h3><div>The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127510"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665845","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}
引用次数: 0
Racial and ethnic differences among Mpox vaccination recipients by vaccination facility type in New York City—August–December 2022 2022年8月至12月,纽约市按疫苗接种机构类型划分的麻疹疫苗接种者的种族和民族差异
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127520
Melanie S. Askari , Michelle Macaraig, Alexandra Ternier, Bindy Crouch
{"title":"Racial and ethnic differences among Mpox vaccination recipients by vaccination facility type in New York City—August–December 2022","authors":"Melanie S. Askari ,&nbsp;Michelle Macaraig,&nbsp;Alexandra Ternier,&nbsp;Bindy Crouch","doi":"10.1016/j.vaccine.2025.127520","DOIUrl":"10.1016/j.vaccine.2025.127520","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate if race and ethnicity were associated with mpox vaccination at routine care sites (i.e., existing healthcare facilities), compared with temporary sites (i.e., government-operated sites).</div></div><div><h3>Methods</h3><div>We analyzed data from New York City's (NYC's) Immunization Information System during August 8–December 14, 2022, the period when routine and temporary mpox vaccination sites were operational. We used generalized estimating equations to assess whether race and ethnicity were associated with vaccination facility type, adjusting for demographics and accounting for doses received.</div></div><div><h3>Results</h3><div>In NYC, 102,583 mpox vaccine doses were administered during August 8–December 14, 2022 (22.1 % at routine care sites and 77.9 % at temporary sites). Black non-Latino and Latino New Yorkers were 61 % and 34 % more likely, respectively, than White non-Latino New Yorkers to get vaccinated at routine care vs temporary sites (adjusted odds ratio [aOR] = 1.61; 95 % CI = 1.54–1.68; aOR = 1.34, 95 % CI = 1.29–1.39).</div></div><div><h3>Conclusions</h3><div>Although fewer persons were vaccinated at routine care sites, compared with temporary sites, routine care enhanced vaccine access for historically marginalized populations during NYC's 2022 mpox outbreak.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127520"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665558","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}
引用次数: 0
COVID-19 vaccine hesitancy and perceived post-vaccination adverse event: Findings from a cross-sectional survey COVID-19疫苗犹豫和疫苗接种后感知的不良事件:来自横断面调查的结果
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127529
Maude Dionne , Chantal Sauvageau , Jeremy K. Ward , Jérémie Sylvain-Morneau , Fátima Gauna , Radhouene Doggui , Ève Dubé
{"title":"COVID-19 vaccine hesitancy and perceived post-vaccination adverse event: Findings from a cross-sectional survey","authors":"Maude Dionne ,&nbsp;Chantal Sauvageau ,&nbsp;Jeremy K. Ward ,&nbsp;Jérémie Sylvain-Morneau ,&nbsp;Fátima Gauna ,&nbsp;Radhouene Doggui ,&nbsp;Ève Dubé","doi":"10.1016/j.vaccine.2025.127529","DOIUrl":"10.1016/j.vaccine.2025.127529","url":null,"abstract":"<div><h3>Introduction</h3><div>In Quebec, COVID-19 vaccine uptake among adults was high for the first two doses but decreased for the subsequent booster doses. This study assesses the relationships between attitudes towards vaccination and self-reported experience and severity of adverse events following immunization (AEFIs).</div></div><div><h3>Methods</h3><div>A web survey of Quebec adults who received at least one dose of the COVID-19 vaccine was conducted in September 2023. Participants share their level of vaccine hesitancy before vaccination and their experience with AEFIs after receiving a dose. Participants were asked to note the severity of the symptoms they believed were due to vaccination. Intention to receive other vaccines in the future was questioned. Two coders performed a qualitative content analysis on reported AEFIs (<em>N</em> = 3808). Descriptive and multivariate logistic regression analyses were performed.</div></div><div><h3>Results</h3><div>Among the 8419 vaccinated respondents, 46.7 % reported having experienced AEFIs. Fatigue or malaise (20.7 %), injection site disorder (17.3 %), musculoskeletal pain (11.2 %), headache (11.0 %), and fever (10.6 %) were the most commonly reported, respectively. Respondents who were very hesitant before the COVID-19 vaccine reported more frequently having a severe AEFI compared to those who were not hesitant (25.0 % vs 3.4 % =, <em>p</em> &lt; 0.001). This affirmation stays true when all severity of adverse events are considered (68.7 % vs 36.9 %) (<em>p</em> &lt; 0.001). Younger age (aOR = 0.98), being a female (aOR = 1.31), a higher education level (University degree aOR = 1.56 vs high school or less), being vaccine-hesitant in general (aOR = 1.69 vs non or less hesitant) were significantly associated (<em>p</em> &lt; 0.001) with self-reported AEFIs in multivariate analysis. Self-reported AEFIs that prevented doing activities (aOR = 4.87) and being vaccine-hesitant in general (aOR = 4.94) were significantly associated with reduced intention to receive other vaccines in the future.</div></div><div><h3>Conclusion</h3><div>Vaccine hesitancy could influence self-reported AEFIs and their perceived severity. Transparent and tailored communication explaining AEFIs while emphasizing strategies to mitigate these effects could helpful. Our findings also have implications for pharmacovigilance.</div><div>301 mots.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127529"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665835","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}
引用次数: 0
Non-typhoidal Salmonella combination vaccines: clinical development plan and regulatory considerations 非伤寒沙门氏菌联合疫苗:临床开发计划和监管考虑
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-19 DOI: 10.1016/j.vaccine.2025.127515
Jean-Louis Excler , Tarun Saluja , Annelies Wilder-Smith , Robert W. Kaminski , Calman A. MacLennan , Marco Cavaleri , Jerome H. Kim
{"title":"Non-typhoidal Salmonella combination vaccines: clinical development plan and regulatory considerations","authors":"Jean-Louis Excler ,&nbsp;Tarun Saluja ,&nbsp;Annelies Wilder-Smith ,&nbsp;Robert W. Kaminski ,&nbsp;Calman A. MacLennan ,&nbsp;Marco Cavaleri ,&nbsp;Jerome H. Kim","doi":"10.1016/j.vaccine.2025.127515","DOIUrl":"10.1016/j.vaccine.2025.127515","url":null,"abstract":"<div><div>Invasive non-typhoidal serovars of <em>Salmonella enterica,</em> <em>S.</em> Typhimurium and <em>S.</em> Enteritidis, (iNTS<em>)</em> are estimated to cause over 500,000 cases of disease leading to more than 79,000 deaths with a high case fatality ratio of 14.5 %. Most infections occur in infants and young children in LMICs in sub–Saharan Africa where host risk factors for iNTS disease such as malaria, malnutrition, HIV infection, and anemia are common. iNTS disease is observed from birth, with a peak incidence early in the second year of life, declining before the age of 3 years. The prevalence of multiple drug resistance of iNTS has increased markedly by decade, emphasizing the need for effective vaccines.</div><div>A clinical development plan and regulatory pathway for licensure of iNTS vaccines has been shaped following the development of Preferred Product Characteristics and R&amp;D Roadmap through a series of expert consultations. Several iNTS alone or combined with Typhoid Conjugate Vaccine platforms are in early clinical development. Encouraging safety and immunogenicity data have prompted developers and manufacturers to plan efficacy trials, aligned with regulatory expectations. It is critical to clearly communicate iNTS disease burden in endemic countries and to discuss complexities related to iNTS single component or combination vaccine clinical development with regulators. An essential component is the disease burden in infants less than 6 months of age, which will inform the optimal age of first vaccination (less than or from 6 months), compatibility across national expanded programme on immunization schedules, and whether a booster dose would be needed. Early regulatory guidance is essential to make informed regulatory decisions and to guide the clinical development plan and licensure pathway. Continued communication with public health stakeholders and end-user representatives will effectively contribute to better awareness and education about iNTS disease and protection afforded by vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127515"},"PeriodicalIF":4.5,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144662409","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}
引用次数: 0
Real-world effectiveness of NVX-CoV2373 and BNT162b2 mRNA COVID-19 vaccination in South Korea NVX-CoV2373和BNT162b2 mRNA COVID-19疫苗在韩国的实际有效性
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-18 DOI: 10.1016/j.vaccine.2025.127496
Eunseon Gwak , Seung-Ah Choe , Kyuwon Kim , Erdenetuya Bolormaa , Jonathan Fix , Muruga Vadivale , Matthew D. Rousculp , Young June Choe
{"title":"Real-world effectiveness of NVX-CoV2373 and BNT162b2 mRNA COVID-19 vaccination in South Korea","authors":"Eunseon Gwak ,&nbsp;Seung-Ah Choe ,&nbsp;Kyuwon Kim ,&nbsp;Erdenetuya Bolormaa ,&nbsp;Jonathan Fix ,&nbsp;Muruga Vadivale ,&nbsp;Matthew D. Rousculp ,&nbsp;Young June Choe","doi":"10.1016/j.vaccine.2025.127496","DOIUrl":"10.1016/j.vaccine.2025.127496","url":null,"abstract":"<div><h3>Objectives</h3><div>In February 2022, NVX-CoV2373 became available in South Korea; real-world effectiveness of multiple doses compared with mRNA-based vaccines has not been thoroughly evaluated.</div></div><div><h3>Methods</h3><div>This retrospective study identified NVX-CoV2373 and BNT162b2 recipients aged ≥12 years from the K-COV-N database. Vaccine groups were propensity score–matched based on demographic characteristics, Seoul capital area residence, income level, comorbidity/disability, prior SARS-CoV-2 infection, and prior vaccination dose/timing. Outcomes were any and severe (intensive-care-unit admission or death within 8 weeks of infection) laboratory-confirmed SARS-CoV-2 infection assessed from 7 days after the third and fourth dose. Adjusted hazard ratios (aHRs) from matched groups measured vaccine effectiveness up to a 180-day risk window.</div></div><div><h3>Results</h3><div>From February to December 2022, 923,833 NVX-CoV2373 and 1,286,604 BNT162b2 doses were administered. The 180-day risk-window aHRs (95% CI) for NVX-CoV2373 compared with BNT162b2 for any SARS-CoV-2 infection were 0.78 (0.76–0.79) post third dose and 0.86 (0.86–0.87) post fourth dose. The 180-day aHRs (95% CI) for severe infection were 0.73 (0.53–1.00) after the third dose and 1.21 (1.03–1.42) after the fourth dose.</div></div><div><h3>Conclusions</h3><div>NVX-CoV2373 demonstrated favorable and similar effectiveness against any and severe SARS-CoV-2 infection, respectively, compared with BNT162b2, with evidence of enhanced NVX-CoV2373 durability.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127496"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657242","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}
引用次数: 0
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