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Zero-Dose Children and Nutrition-Service Gaps: A Case for Integrated Delivery in Low- and Middle-Income Countries. 零剂量儿童和营养服务缺口:低收入和中等收入国家综合提供的案例。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090740
Kevin Tang, Uchenna Agu, Fanny Sandalinas, Andreas Hasman, Annette Imohe, Ibrahim Dadari
{"title":"Zero-Dose Children and Nutrition-Service Gaps: A Case for Integrated Delivery in Low- and Middle-Income Countries.","authors":"Kevin Tang, Uchenna Agu, Fanny Sandalinas, Andreas Hasman, Annette Imohe, Ibrahim Dadari","doi":"10.3390/vaccines14090740","DOIUrl":"10.3390/vaccines14090740","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Zero-dose children, defined as those who have not received any routine vaccines, are a central priority of global immunization equity efforts and are widely considered to be among the most deprived children. This study examined whether zero-dose status also identifies children who have not received nutrition services and who are nutritionally vulnerable. <b>Methods:</b> We analyzed data from the Demographic and Health Surveys and Multiple Indicator Cluster Surveys across 55 low- and middle-income countries, including 560,314 children aged 12 to 23 months. We assessed the association between zero-dose status and non-receipt of vitamin A supplementation (VAS) and deworming, and between zero-dose status and the Multidimensional Poverty Index (MPI). <b>Results:</b> Zero-dose status was weakly associated with non-receipt of VAS and deworming (most phi coefficients between 0.1 and 0.3) and with the MPI (mean 0.11), and showed negligible correlation with child nutritional status, measured by stunting and wasting (mean phi 0.03). Most zero-dose children nonetheless had not received these nutrition services, with 62% not receiving VAS and 72% not receiving deworming, amounting to an estimated 12.5 and 14.4 million children, concentrated in a small number of countries. This reflected the generally low coverage of nutrition interventions across all children rather than a specific concentration among the zero-dose. <b>Conclusions:</b> Immunization outreach platforms can therefore be used to extend nutrition services to large numbers of under-reached children.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Memory B Cell Repertoire of a Repeatedly Vaccinated Individual Includes Influenza Hemagglutinin-Specific Cross-Group Binders with Affinity Beyond A(H1N1)pdm09 and A(H3N2) Seasonal Strains. 反复接种疫苗个体的记忆B细胞库包括流感血凝素特异性跨组结合物,其亲和力超过a (H1N1)pdm09和a (H3N2)季节性菌株。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090742
Margarita Mishina, Christopher M Horn, Zachary Ende, Vasiliy Mishin, Crystal Holiday, Sujatha Seenu, Jason R Wilson, Weiping Cao, Mili Sheth, Dhwani Batra, Jessie Chang, Paul Carney, Min Z Levine, James Stevens, Michael R Weigand, Ian A York, Shivaprakash Gangappa
{"title":"Memory B Cell Repertoire of a Repeatedly Vaccinated Individual Includes Influenza Hemagglutinin-Specific Cross-Group Binders with Affinity Beyond A(H1N1)pdm09 and A(H3N2) Seasonal Strains.","authors":"Margarita Mishina, Christopher M Horn, Zachary Ende, Vasiliy Mishin, Crystal Holiday, Sujatha Seenu, Jason R Wilson, Weiping Cao, Mili Sheth, Dhwani Batra, Jessie Chang, Paul Carney, Min Z Levine, James Stevens, Michael R Weigand, Ian A York, Shivaprakash Gangappa","doi":"10.3390/vaccines14090742","DOIUrl":"10.3390/vaccines14090742","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Humans are primarily infected by two distinct seasonal influenza A virus (IAV) subtypes, A(H1N1)pdm09 and A(H3N2). Because IAV mutates rapidly, it continuously escapes existing protective antibodies. However, repeated exposure to these evolving strains increases the diversity of virus-specific memory B cell (MBC) population. To investigate the extent of this diversity and cross-reactivity of IAV- specific immunity in adults, and its possible impact on emerging strains, we analyzed the hemagglutinin (HA)-specific MBC repertoire of an adult frequently immunized with seasonal vaccines. <b>Methods</b>: High-throughput single-cell sequencing of HA probe-positive MBCs collected from an individual with repeated seasonal influenza vaccination was performed. Monoclonal antibodies (mAbs) from multicell clonotypes were tested for HA binding and influenza virus neutralization. <b>Results</b>: Two clonotypes were identified that bound to both A(H1) and A(H3) HAs from strains circulating before and after the season of blood collection. Both clonotypes neutralized A(H3N2) strains, while one also neutralized A(H1N1)pdm09 strains. Notably, these cross-group binders showed affinity for A(H5), A(H7) and A(H9) avian influenza HAs and neutralized bovine A(H5N1) IAV. <b>Conclusions</b>: Our findings suggest that seasonal vaccination can support pre-existing cross-reactive B-cell immunity in some individuals. This underscores the importance of studying influenza-specific MBC repertoires across diverse populations to better understand immune dynamics and improve vaccine design.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Does Migration Affect a Child's Immunization Coverage? A Cross-Sectional Analytical Study of India. 移民是否会影响儿童的免疫接种覆盖率?印度的横断面分析研究。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090744
Pawan Kumar, Pritu Dhalaria, Sanjay Kapur, Ajay Kumar Verma, Ajeet Kumar Singh, Pretty Priyadarshini, Kapil Singh, Bhupendra Tripathi, Arindam Ray
{"title":"Does Migration Affect a Child's Immunization Coverage? A Cross-Sectional Analytical Study of India.","authors":"Pawan Kumar, Pritu Dhalaria, Sanjay Kapur, Ajay Kumar Verma, Ajeet Kumar Singh, Pretty Priyadarshini, Kapil Singh, Bhupendra Tripathi, Arindam Ray","doi":"10.3390/vaccines14090744","DOIUrl":"10.3390/vaccines14090744","url":null,"abstract":"<p><p><b>Introduction</b>: India's immunization initiatives are among the largest globally, characterized by a substantial birth cohort of 27 million children annually, and have achieved significant progress in increasing coverage through the UIP. However, there are still challenges that persist, and multiple determinants contribute to the existing challenges; migration is one of them. Migration has always been a key driver of socio-economic and demographic changes, particularly in low and middle-income countries (LMICs). Specifically, there is a need to better understand the vulnerabilities of immunization among recent migrants. To examine this, the study explores the association between a mother's recent migration and the full immunization coverage of children aged 12-23 months in India. <b>Data & Methods</b>: Our study utilized data from the National Family Health Survey-5 (2019-21). The outcome variable of interest in this study is the full immunization among children aged 12-23 months (receipt of all basic vaccinations). The primary predictor variable in this study was recent maternal migration, defined as the mother's duration of residence at the current place of residence. We used a series of multivariate logistic regression models to examine the relationship between full Immunization among children and maternal migration status, with some data restrictions in the models. <b>Results</b>: The results show a 17 percentage-point difference in full immunization between children of migrant and non-migrant mothers. The adjusted odds ratios of children of mothers who had recently migrated had significantly lower odds of full immunization (aOR: 0.39, 95% CI: 0.35-0.43) compared to children whose mothers had not recently migrated. Even across the household wealth quintile and social groups, the recent migration of the mother was associated with being less likely to be fully immunized among children 12-23 months. <b>Conclusions</b>: The findings of this study provide significant quantitative evidence that recent migration (less than 3 years) of mother is a key factor influencing Immunization coverage and is a predictor of full immunization among children aged 12-23 months in India. The recent migration was consistently linked with lower odds of full immunization coverage across different household wealth levels and social groups. This study suggests that children of recently migrated mother are a vulnerable subgroup of the population at risk of not receiving full immunization among children aged 12-23 months.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
HPV Genotype Distribution, Vaccine Protection Gaps, and Co-Infection Network Centrality Among 8515 Clinical Women in Wuxi, China: A Retrospective Cross-Sectional Study. 中国无锡8515名临床妇女的HPV基因型分布、疫苗保护差距和共感染网络中心性:一项回顾性横断面研究
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090741
Baocai Ran, Han Wu, Fengjuan Zhang
{"title":"HPV Genotype Distribution, Vaccine Protection Gaps, and Co-Infection Network Centrality Among 8515 Clinical Women in Wuxi, China: A Retrospective Cross-Sectional Study.","authors":"Baocai Ran, Han Wu, Fengjuan Zhang","doi":"10.3390/vaccines14090741","DOIUrl":"10.3390/vaccines14090741","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Regional HPV genotype data for the Yangtze River Delta remain scarce, limiting evidence-based vaccine and screening policies. This study characterised the HPV genotype distribution, the vaccine protection gaps, and the co-infection network structure among clinical women in Wuxi, a prefecture-level city in the Yangtze River Delta region of Jiangsu Province, China. <b>Methods</b>: We retrospectively analysed all 8515 cervical HPV genotyping records from Xishan People's Hospital of Wuxi City (January 2024-June 2025) using a 23-type fluorescent PCR panel classified by the International Agency for Research on Cancer (IARC) criteria. <b>Results</b>: The overall HPV prevalence was 22.83% (1944/8515; 95% CI 21.9-23.8%). The five leading types were HPV52 (4.82%), HPV58 (3.14%), HPV16 (2.96%), HPV53 (2.50%), and HPV42 (2.08%); HPV18 (0.74%) ranked below two unvaccinated carcinogens, HPV51 (1.76%, IARC Group 1) and HPV68 (1.68%, Group 2A). The age-stratified prevalence was U-shaped (χ<sup>2</sup> = 123.27, <i>p</i> < 0.001), peaking at ≤20 years (52.94%; exploratory, n = 51) and ≥61 years (34.66%). Among the 1944 women with positive results, 43.0% were completely unprotected by the nonavalent vaccine, and 60.4% harboured at least one non-9vHPV type; HPV51 and HPV68 together accounted for 15.08% of the positive cases. In the co-infection network (n = 585 multiple-type infections), HPV52 achieved the highest degree centrality (281 co-infection events; normalised degree = 0.0218) and appeared in 8 of the 15 most frequent dual-type pairs, with observed/expected ratios of 6.5-14.8-fold. <b>Conclusions</b>: These findings reveal a clinically substantial vaccine protection gap and support the prioritisation of HPV51 and HPV68 in next-generation vaccine design.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Farm-Gate Prices as an Economic Signal of Foot-and-Mouth Disease Vaccination Performance in Hanwoo Cattle: A Nationwide Time-Lag Analysis. 农场收购价作为韩宇牛口蹄疫疫苗接种效果的经济信号:一个全国性的时滞分析。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090743
Dae Sung Yoo, Yoonyoung Choi, Ji-Hyun Son, Ho-Seong Cho, Yeonsu Oh
{"title":"Farm-Gate Prices as an Economic Signal of Foot-and-Mouth Disease Vaccination Performance in Hanwoo Cattle: A Nationwide Time-Lag Analysis.","authors":"Dae Sung Yoo, Yoonyoung Choi, Ji-Hyun Son, Ho-Seong Cho, Yeonsu Oh","doi":"10.3390/vaccines14090743","DOIUrl":"10.3390/vaccines14090743","url":null,"abstract":"<p><p><b>Background/Objectives</b>: In mandatory livestock vaccination programs, post-vaccination immunity depends on both vaccine characteristics and consistent on-farm implementation. We evaluated whether Hanwoo farm-gate prices were temporally associated with subsequent foot-and-mouth disease (FMD) structural protein (SP) antibody seropositivity, used as a population-level proxy for vaccination performance. <b>Methods</b>: We analyzed 75,408 individual SP antibody records from Hanwoo cattle on commercial farms (≥50 head) sampled on-farm from April 2019 to December 2022 and linked monthly seropositivity to four price metrics. A separate 2022 cohort (<i>n</i> = 131,805) was analyzed by multivariable logistic regression. Cross-correlations assessed price-leading lags of 0-12 months; linear and exploratory hinge models evaluated association magnitude and a candidate breakpoint. <b>Results</b>: Overall SP seropositivity was 96.3%. Cattle from commercial farms had higher odds of antibody negativity than those from smaller farms (adjusted odds ratio [OR] 1.15, 95% confidence interval [CI] 1.05-1.26), whereas each additional recorded vaccination was associated with lower odds (OR 0.89, 95% CI 0.88-0.90). Monthly price and the 3-month moving-average price showed their strongest associations with subsequent seropositivity at 7 and 6 months, respectively (r = 0.519 and 0.506; both <i>p</i> < 0.001). Month-to-month price changes were not associated with seropositivity. An exploratory hinge model identified a candidate breakpoint near KRW 6.26 million per 600 kg live animal. <b>Conclusions</b>: Sustained farm-gate price conditions, rather than short-term volatility, were associated with subsequent FMD post-vaccination seropositivity. Livestock price data may provide a contextual signal for targeting communication and vaccination support activities; however, this ecological association does not demonstrate price-driven behavioral change at individual farms, and the candidate breakpoint requires prospective validation.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Decoding the Factors Influencing Parental Vaccine Decision-Making: Insights from Saudi Arabia on COVID-19 Vaccination for Children-Lessons for Future Pandemics. 解读影响父母疫苗决策的因素:沙特阿拉伯对儿童COVID-19疫苗接种的见解——为未来大流行提供的经验教训。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-27 DOI: 10.3390/vaccines14090745
Lamyaa Kassem, Mohammed Saif Anaam, Fatimah A Aldaiji, Fatimah A Alqarzaee, Farah A Almogarri, Hana A Almansour, Nouf A Almutairi, Mohamed Hassan Elnaem, Hadiah Almutairi, Sulaiman Ibrahim Alsohaim, Khalid Siddeeg, Waleed M Altowayan
{"title":"Decoding the Factors Influencing Parental Vaccine Decision-Making: Insights from Saudi Arabia on COVID-19 Vaccination for Children-Lessons for Future Pandemics.","authors":"Lamyaa Kassem, Mohammed Saif Anaam, Fatimah A Aldaiji, Fatimah A Alqarzaee, Farah A Almogarri, Hana A Almansour, Nouf A Almutairi, Mohamed Hassan Elnaem, Hadiah Almutairi, Sulaiman Ibrahim Alsohaim, Khalid Siddeeg, Waleed M Altowayan","doi":"10.3390/vaccines14090745","DOIUrl":"10.3390/vaccines14090745","url":null,"abstract":"<p><p><b>Background</b>: In Gulf nations such as Saudi Arabia, where COVID-19 vaccination is optional, parental decision-making regarding vaccinating children is critical. Understanding the psychological factors that drive these decisions can shape future vaccination strategies. <b>Methods</b>: Between November 2021 and January 2022, a cross-sectional, web-based validated survey was conducted using chain-referral (snowball) sampling across multiple social media platforms. A total of 2176 parents residing in Saudi Arabia with children aged 5-18 years participated. The 5C psychological antecedents (confidence, complacency, constraints, calculation, and collective responsibility) were assessed. Multinomial logistic regression was employed to determine factors influencing parental decision-making across three child age groups: 5-11 years only, 12-18 years only, and both age ranges (5-18 years). <b>Results</b>: Overall, 77.9% of parents agreed to receive all scheduled doses of the COVID-19 vaccine themselves, while 58.6% agreed to vaccinate children aged 12 years or older, and only 41.9% agreed to vaccinate children younger than 12 years. Fathers were significantly more likely to accept vaccination [Odds ratio (OR) = 17.48, <i>p</i> = 0.01] compared to mothers, who showed higher reluctance (OR = 15.08, <i>p</i> = 0.01). Having a child aged 5-11 years increased reluctance threefold (OR = 3.16, <i>p</i> = 0.01). Parents who believed that returning to school was safe showed increased vaccine acceptance (OR = 4.32, <i>p</i> = 0.01). Confidence and collective responsibility were the strongest positive predictors of vaccine acceptance, particularly for younger children, with OR estimates of 1.23-1.53 for confidence and 1.33-2.13 for collective responsibility. Conversely, extensive information seeking (calculation) was associated with lower acceptance (OR = 0.09, <i>p</i> = 0.03). A history of COVID-19 hospitalization among family or friends was significantly associated with increased parental reluctance (<i>p</i> = 0.03). <b>Conclusions</b>: This study identifies key psychological and demographic factors influencing parental decisions regarding COVID-19 vaccination for children. Building parental confidence and fostering collective responsibility are essential for increasing vaccination rates, particularly among parents of younger children aged 5-11 years. Healthcare authorities should address vaccine safety concerns, provide clear and accurate information, and tailor strategies to parents who remain hesitant.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611791/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Expert Perspective on a New Recombinant Pertussis-Only Vaccine and Its Potential Clinical and Programmatic Advantages in Australia, New Zealand, and Beyond. 一种新的重组百日咳疫苗及其在澳大利亚、新西兰和其他地区潜在的临床和规划优势的专家观点。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-26 DOI: 10.3390/vaccines14090736
Peter McIntyre, Anita H J van den Biggelaar, Frank Beard, Mary Nowlan, Annette K Regan, Rodney Pearce, Terry Nolan, Catherine Hughes, Peter Richmond
{"title":"An Expert Perspective on a New Recombinant Pertussis-Only Vaccine and Its Potential Clinical and Programmatic Advantages in Australia, New Zealand, and Beyond.","authors":"Peter McIntyre, Anita H J van den Biggelaar, Frank Beard, Mary Nowlan, Annette K Regan, Rodney Pearce, Terry Nolan, Catherine Hughes, Peter Richmond","doi":"10.3390/vaccines14090736","DOIUrl":"10.3390/vaccines14090736","url":null,"abstract":"<p><p>Despite high childhood coverage and booster doses of pertussis vaccination across the life course, pertussis (whooping cough) outbreaks continue to occur, including in Australia and New Zealand. In January 2026, the European Medicines Agency (EMA) granted marketing authorisation to a new pertussis-only booster vaccine (VacPertagen<sup>TM</sup>): the first time in two decades that a new acellular pertussis vaccine has been approved in the European Union. Anticipating future licensure of the vaccine in Australia and New Zealand, an expert panel was convened to discuss the clinical and programmatic advantages that this new vaccine may offer in the context of current pertussis epidemiology and vaccination strategies inSuch advantages may also be applicable to other high-income countries experiencing ongoing pertussis outbreaks.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developing an Evidence-Informed Strategic Framework for Veterinary Vaccine Manufacturing Modernization Toward PIC/S GMP Compliance. 为符合PIC/S GMP的兽医疫苗生产现代化制定循证战略框架。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-26 DOI: 10.3390/vaccines14090738
Terdsak Yano, Thanaporn Eiamsam-Ang, Tossapond Kewprasopsak, Panuwat Yamsakul
{"title":"Developing an Evidence-Informed Strategic Framework for Veterinary Vaccine Manufacturing Modernization Toward PIC/S GMP Compliance.","authors":"Terdsak Yano, Thanaporn Eiamsam-Ang, Tossapond Kewprasopsak, Panuwat Yamsakul","doi":"10.3390/vaccines14090738","DOIUrl":"10.3390/vaccines14090738","url":null,"abstract":"&lt;p&gt;&lt;p&gt;&lt;b&gt;Background/Objectives&lt;/b&gt;: Veterinary vaccine manufacturing is essential for controlling transboundary animal diseases, strengthening animal health systems, and supporting livestock development, particularly in Southeast Asia where livestock production continues to expand. However, modernization toward Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) compliance remains challenging because it requires coordinated development across regulatory, technical, organizational, financial, and governance domains. This study aimed to develop an evidence-informed strategic framework for veterinary vaccine manufacturing modernization through a structured and systematically documented framework development methodology integrating multidisciplinary evidence and practice-informed implementation experience. &lt;b&gt;Methods&lt;/b&gt;: An evidence-informed framework development study was conducted through the multidisciplinary integration of multiple evidence sources, including international regulatory guidance, peer-reviewed scientific literature, multidisciplinary feasibility assessment, and practice-informed implementation experience derived from a government-commissioned consultancy project. Framework development followed a structured methodology comprising evidence collection, evidence categorization, multidisciplinary evidence synthesis, framework development, iterative refinement, and expert-informed validation. Only generalized methodological principles and potentially transferable implementation knowledge were incorporated to ensure confidentiality of project-specific information. &lt;b&gt;Results&lt;/b&gt;: Multidisciplinary evidence synthesis identified ten evidence domains encompassing regulatory, technical, organizational, economic, legal, environmental, governance, workforce, infrastructure, and implementation considerations. These domains were translated through a structured process into an evidence-informed strategic framework organized around four sequential modernization phases-Design, Construction, Validation, and Continuous Improvement-supported by cross-cutting strategic enablers. Iterative refinement through expert review, technical consultation, and implementation verification strengthened the framework's scientific consistency, regulatory alignment, and practical applicability. &lt;b&gt;Conclusions&lt;/b&gt;: Veterinary vaccine manufacturing modernization should be regarded as a multidisciplinary organizational transformation rather than solely as an infrastructure or engineering project. Beyond proposing a strategic framework, this study provides a transparent, systematically documented and traceable methodology for translating multidisciplinary evidence into strategic decision-support tools. The proposed framework may assist governments, regulatory authorities, vaccine manufacturers, and researchers in developing evidence-informed modernization strategies for veterinary biological manufacturing systems, particularly in low- an","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Estimating and Projecting Efficacy of Monoclonal Antibodies Against Respiratory Syncytial Virus Beyond Clinical Trial Periods. 估计和预测抗呼吸道合胞病毒单克隆抗体在临床试验期后的疗效。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-26 DOI: 10.3390/vaccines14090737
Dawei Wang, John C Lang, Klodeta Kura, Yao-Hsuan Chen
{"title":"Estimating and Projecting Efficacy of Monoclonal Antibodies Against Respiratory Syncytial Virus Beyond Clinical Trial Periods.","authors":"Dawei Wang, John C Lang, Klodeta Kura, Yao-Hsuan Chen","doi":"10.3390/vaccines14090737","DOIUrl":"10.3390/vaccines14090737","url":null,"abstract":"<p><strong>Background: </strong>Clinical trials of respiratory syncytial virus (RSV) monoclonal antibodies (mAbs) have followed participants for up to 180 days, covering a typical single RSV season. However, to assess the full clinical impact of mAb administration, post-trial efficacy estimates are needed, particularly in countries where RSV circulation extends beyond six months.</p><p><strong>Methods: </strong>In this study, we applied a previously published Bayesian framework to estimate how the level of protective efficacy against RSV provided by clesrovimab and nirsevimab changes over the first year after administration. Using this Bayesian framework, which modeled new infections as Poisson processes with a Gaussian process prior for the force of infection and a parametric waning function for the intervention arm, we estimated placebo incidence rates and posterior waning functions. We validated our estimates by calculating model-estimated cumulative trial-period efficacy using an Incidence Rate Ratio (IRR) approach and by reconstructing event-free probability curves, comparing both with published clinical trial results.</p><p><strong>Results: </strong>Model-derived cumulative efficacy estimates closely matched trial-reported results for both products. The model-projected instantaneous probability of being protected at one year-an extrapolation beyond the observed trial follow-up-was 24.6% (95% CrI: 1.6-57.0%) for clesrovimab and 12.8% (95% CrI: 1.2-44.4%) for nirsevimab, with substantially overlapping credible intervals.</p><p><strong>Conclusions: </strong>Both RSV mAbs were projected to provide some level of protection throughout the first year following administration, with broadly similar levels of protection.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond Efficacy: Policy, Delivery, and Equity Determinants of Long-Acting Monoclonal Antibody Uptake for Infant RSV Prevention-A WAidid Consensus Document. 功效之外:用于婴儿RSV预防的长效单克隆抗体摄取的政策、递送和公平决定因素——一份待定共识文件。
IF 3.5 3区 医学
Vaccines Pub Date : 2026-08-26 DOI: 10.3390/vaccines14090739
Susanna Esposito, Bahaa Abu-Raya, Brian Eley, Natasha Halasa, Federico Martinon-Torres, Asuncion Mejias, Vana Spoulou, Tobias Tenenbaum, Juan Pablo Torres, Albert Osterhaus, Octavio Ramilo, Nicola Principi
{"title":"Beyond Efficacy: Policy, Delivery, and Equity Determinants of Long-Acting Monoclonal Antibody Uptake for Infant RSV Prevention-A WAidid Consensus Document.","authors":"Susanna Esposito, Bahaa Abu-Raya, Brian Eley, Natasha Halasa, Federico Martinon-Torres, Asuncion Mejias, Vana Spoulou, Tobias Tenenbaum, Juan Pablo Torres, Albert Osterhaus, Octavio Ramilo, Nicola Principi","doi":"10.3390/vaccines14090739","DOIUrl":"10.3390/vaccines14090739","url":null,"abstract":"&lt;p&gt;&lt;p&gt;&lt;b&gt;Background:&lt;/b&gt; Long-acting monoclonal antibodies have become an important strategy for preventing respiratory syncytial virus (RSV) disease in infants. Nirsevimab is the first product for which substantial post-licensure implementation data are available, whereas real-world evidence on clesrovimab remains limited. Although nirsevimab has demonstrated high efficacy, its uptake varies considerably across countries, healthcare systems, delivery settings, and population subgroups. This World Association for Infectious Diseases and Immunological Disorders (WAidid) consensus document examines the policy, organizational, economic, and equity-related determinants that shape real-world implementation of long-acting monoclonal antibodies for infant RSV prevention. &lt;b&gt;Methods:&lt;/b&gt; This study was conducted as a structured narrative review and WAidid expert consensus document. A structured literature search was performed in PubMed and Embase for English-language publications relevant to nirsevimab uptake and implementation, complemented by targeted review of surveillance reports, policy documents, and public health guidance from the ECDC, UKHSA, and CDC, as well as reference lists of selected publications. Eligible sources included observational and real-world implementation studies, systematic reviews and meta-analyses, economic evaluations, guidelines, policy statements, surveillance reports, and relevant narrative reviews. Evidence was synthesized qualitatively according to policy frameworks, financing and reimbursement, delivery pathways, demographic and socioeconomic determinants, and healthcare-system factors influencing uptake. No statistical software was used because no quantitative re-analysis or meta-analysis was performed. &lt;b&gt;Results&lt;/b&gt;: Nirsevimab uptake was strongly influenced by national RSV prevention policies, particularly whether countries adopted universal infant monoclonal antibody programs, maternal RSV vaccination strategies, dual maternal-infant approaches, or targeted risk-based models. Universal, publicly funded programs integrated into neonatal care achieved the highest and most homogeneous coverage, especially when administration occurred before hospital discharge and was supported by registry-based recall systems for infants born outside the RSV season. In contrast, fragmented, outpatient-only, insurance-dependent, or partially reimbursed models were associated with lower, delayed, or more variable uptake. Additional determinants included product cost, reimbursement pathways, provider practices, caregiver awareness and health literacy, insurance status, income, race and ethnicity, geographic deprivation, and access to primary pediatric care. Most available evidence comes from high-income countries, limiting generalizability to low- and middle-income settings, where RSV burden is greatest and implementation constraints may differ. &lt;b&gt;Conclusions:&lt;/b&gt; Successful implementation of long-acting monoclonal antibodies for infant","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"14 9","pages":""},"PeriodicalIF":3.5,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13611142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149064535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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