Pub Date : 2026-01-25DOI: 10.1016/j.vaccine.2026.128261
Cassandra Barber , Mikayla Barber , Janet S.W. Lee , Joseph Ting , Shannon E. MacDonald
Aim
Infant prematurity, low birth weight, and critical illness often require neonatal intensive care unit (NICU) admission. Although beneficial, hospitalization may interrupt the usual processes through which infants receive vaccines in the community. To mitigate potential disruptions to scheduled vaccinations, an infant's NICU stay may be an opportunity for timely vaccine delivery. The frequency and nature of these practices are known to vary across Canada. This study aimed to determine what vaccination policies, practices, and procedures exist in Canadian Level-III NICUs.
Methods
A pan-Canadian environmental scan was conducted from May to October 2023 to identify vaccine policies, practices, and procedures from Level-III NICUs. Data collection included an internet search and email consultation with NICU professionals (i.e., nurses, physicians, etc.). Information was synthesized to identify the commonalities and differences between vaccination practices across Canada.
Results
Twenty-one (out of 32 contacted) Level-III NICUs responded, with all respondents (21/21) confirming that their NICU provided selected routine vaccinations and respiratory syncytial virus (RSV) prophylaxis to admitted infants. NICU nurses (21/21) were the main vaccine provider, with hospitals in one province augmenting delivery with public health nurses (3/21). Only 8/21 NICUs reported delivering rotavirus vaccines prior to discharge.
Conclusion
Across Canada, all surveyed Level-III NICUs reported delivering some routine vaccinations, indicating an effort to optimize vaccine uptake during hospitalization. There were variations in the specific vaccines (e.g. rotavirus vaccines) provided. Understanding where and why these variations exist is crucial for informing and enhancing evidence-informed NICU vaccination programs nationwide.
{"title":"Vaccination policies, practices, and procedures in level-III neonatal intensive care units across Canada: An environmental scan","authors":"Cassandra Barber , Mikayla Barber , Janet S.W. Lee , Joseph Ting , Shannon E. MacDonald","doi":"10.1016/j.vaccine.2026.128261","DOIUrl":"10.1016/j.vaccine.2026.128261","url":null,"abstract":"<div><h3>Aim</h3><div>Infant prematurity, low birth weight, and critical illness often require neonatal intensive care unit (NICU) admission. Although beneficial, hospitalization may interrupt the usual processes through which infants receive vaccines in the community. To mitigate potential disruptions to scheduled vaccinations, an infant's NICU stay may be an opportunity for timely vaccine delivery. The frequency and nature of these practices are known to vary across Canada. This study aimed to determine what vaccination policies, practices, and procedures exist in Canadian Level-III NICUs.</div></div><div><h3>Methods</h3><div>A pan-Canadian environmental scan was conducted from May to October 2023 to identify vaccine policies, practices, and procedures from Level-III NICUs. Data collection included an internet search and email consultation with NICU professionals (i.e., nurses, physicians, etc.). Information was synthesized to identify the commonalities and differences between vaccination practices across Canada.</div></div><div><h3>Results</h3><div>Twenty-one (out of 32 contacted) Level-III NICUs responded, with all respondents (21/21) confirming that their NICU provided selected routine vaccinations and respiratory syncytial virus (RSV) prophylaxis to admitted infants. NICU nurses (21/21) were the main vaccine provider, with hospitals in one province augmenting delivery with public health nurses (3/21). Only 8/21 NICUs reported delivering rotavirus vaccines prior to discharge.</div></div><div><h3>Conclusion</h3><div>Across Canada, all surveyed Level-III NICUs reported delivering some routine vaccinations, indicating an effort to optimize vaccine uptake during hospitalization. There were variations in the specific vaccines (e.g. rotavirus vaccines) provided. Understanding where and why these variations exist is crucial for informing and enhancing evidence-informed NICU vaccination programs nationwide.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128261"},"PeriodicalIF":4.5,"publicationDate":"2026-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055878","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}
Pub Date : 2026-01-24DOI: 10.1016/j.vaccine.2026.128240
Alexandra N. Paxitzis , Oladayo A. Oyebanji , Olajide J. Olagunju , Debbie Keresztesy , Mike Payne , Vaishnavi Ragavapuram , Nicholas Sundheimer , Ellen See , Dennis Wilk , Yi Cao , Yasin Abul , Clare Nugent , Evan Dickerson , Tiffany Wallace , Laurel Holland , Aman Nanda , Walther M. Pfeifer , Alejandro B. Balazs , Christopher L. King , Stefan Gravenstein , Jürgen Bosch
Background
The COVID-19 pandemic has greatly affected nursing home residents (NHRs), a vulnerable group with high rates of illness and death. While vaccination is essential for reducing infections and severe outcomes in the short term, it is important to understand how long antibody levels and neutralizing activity last. This understanding will help us create effective public health strategies for the long term. According to current CDC guidelines, individuals over 65 should receive a booster dose six months after their previous vaccination.
Methods
This observational retrospective cohort study analyzed post-vaccination serum from samples with up to 400 days of follow-up from 697 NHRs and 127 healthcare workers (HCWs) across Northeast Ohio and Rhode Island. Analyses were conducted to model decay rates of neutralizing and binding antibody titers and the impact of previous exposures to SARS-CoV-2 on these decay rates.
Results
Results indicate that NHRs show Wuhan and Omicron BA.4/5 neutralizing and binding antibody titers diminish significantly from 2 weeks to 12 months post-vaccination. NHRs with prior infection show higher peak antibody titers and slower decay than those naive to infection. Antibody levels after vaccination for infection-naive NHR lagged HCW and NHR with prior infection, but then decayed at a similar rate.
Conclusion
The immunologic findings in this cohort of NHR align with the existing real-world clinical effectiveness data in older individuals and support the CDC recommendation of a bi-annual vaccination to reduce severe COVID-19 outcomes in persons age 65 and older.
{"title":"Antibody responses to SARS-CoV-2 vaccine in nursing home residents support a Bi-annual update schedule","authors":"Alexandra N. Paxitzis , Oladayo A. Oyebanji , Olajide J. Olagunju , Debbie Keresztesy , Mike Payne , Vaishnavi Ragavapuram , Nicholas Sundheimer , Ellen See , Dennis Wilk , Yi Cao , Yasin Abul , Clare Nugent , Evan Dickerson , Tiffany Wallace , Laurel Holland , Aman Nanda , Walther M. Pfeifer , Alejandro B. Balazs , Christopher L. King , Stefan Gravenstein , Jürgen Bosch","doi":"10.1016/j.vaccine.2026.128240","DOIUrl":"10.1016/j.vaccine.2026.128240","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic has greatly affected nursing home residents (NHRs), a vulnerable group with high rates of illness and death. While vaccination is essential for reducing infections and severe outcomes in the short term, it is important to understand how long antibody levels and neutralizing activity last. This understanding will help us create effective public health strategies for the long term. According to current CDC guidelines, individuals over 65 should receive a booster dose six months after their previous vaccination.</div></div><div><h3>Methods</h3><div>This observational retrospective cohort study analyzed post-vaccination serum from samples with up to 400 days of follow-up from 697 NHRs and 127 healthcare workers (HCWs) across Northeast Ohio and Rhode Island. Analyses were conducted to model decay rates of neutralizing and binding antibody titers and the impact of previous exposures to SARS-CoV-2 on these decay rates.</div></div><div><h3>Results</h3><div>Results indicate that NHRs show Wuhan and Omicron BA.4/5 neutralizing and binding antibody titers diminish significantly from 2 weeks to 12 months post-vaccination. NHRs with prior infection show higher peak antibody titers and slower decay than those naive to infection. Antibody levels after vaccination for infection-naive NHR lagged HCW and NHR with prior infection, but then decayed at a similar rate.</div></div><div><h3>Conclusion</h3><div>The immunologic findings in this cohort of NHR align with the existing real-world clinical effectiveness data in older individuals and support the CDC recommendation of a bi-annual vaccination to reduce severe COVID-19 outcomes in persons age 65 and older.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128240"},"PeriodicalIF":4.5,"publicationDate":"2026-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047752","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}
Pub Date : 2026-01-23DOI: 10.1016/j.vaccine.2026.128262
George N. Okoli , Mike Y.W. Kwan , Eunice L.Y. Chan , Caitriona Murphy , Joshua S.C. Wong , Huiying Chua , Malik Peiris , Benjamin J. Cowling , So-Lun Lee
Background
We assessed the effectiveness of SARS-CoV-2 vaccines against COVID-19-associated hospitalisation in paediatric patients in Hong Kong.
Methods
We conducted a test-negative design study in hospitalised children 1–17 years old admitted with recent-onset (≤5 days) acute respiratory illness in two large public hospitals in Hong Kong during successive SARS-CoV-2 epidemic waves between April 2022 and February 2024 dominated by the Omicron variant. We defined having been vaccinated as receipt of ≥1 SARS-CoV-2 vaccine dose within six months prior to hospitalisation, and for a sensitivity analysis, within twelve months of hospitalisation. Children who had only received one dose of vaccine and had no prior infection were excluded. We estimated VE against laboratory-confirmed SARS-CoV-2 infection separately for 1–4-year-olds and 5–17-year-olds, by conditional logistic regression stratified by calendar time (week) and adjusted for potential confounders.
Results
There were 6308 patients. The proportion of the vaccinated within six months of hospitalisation differed significantly between cases and controls in all strata of the assessed individual sociodemographic/health-related characteristics in the 5–17-year-olds, and in 1–4-year-olds who had a chronic medical condition. Overall, VE was moderate for 1–4-year-olds [41% (23–56%)] and for 5–17-year-olds [54% (10–66%)]. VE was higher in those who had received a mRNA vaccine: 87% (0–98%) and 82% (59–92%) compared with a lower VE for those who had received an inactivated vaccine: 39% (17–54%) and 30% (−19–58%), respectively for 1–4-year-olds and 5–17-year-olds although with a higher degree of imprecision in the VE for mRNA in 1–4-year-olds. In both age groups, VE was higher for those who had had no previous SARS-CoV-2 infection compared with for those who had had a previous infection.
Conclusions
SARS-CoV-2 vaccines, particularly mRNA vaccines, provided substantial protection against paediatric COVID-19-associated hospitalisations in Hong Kong during two successive SARS-CoV-2 epidemic waves dominated by the Omicron variant.
{"title":"Estimates of SARS-CoV-2 vaccine effectiveness against COVID-19-associated hospitalisation in paediatric patients in Hong Kong during two successive SARS-CoV-2 epidemic waves dominated by the Omicron variant: A test-negative design study","authors":"George N. Okoli , Mike Y.W. Kwan , Eunice L.Y. Chan , Caitriona Murphy , Joshua S.C. Wong , Huiying Chua , Malik Peiris , Benjamin J. Cowling , So-Lun Lee","doi":"10.1016/j.vaccine.2026.128262","DOIUrl":"10.1016/j.vaccine.2026.128262","url":null,"abstract":"<div><h3>Background</h3><div>We assessed the effectiveness of SARS-CoV-2 vaccines against COVID-19-associated hospitalisation in paediatric patients in Hong Kong.</div></div><div><h3>Methods</h3><div>We conducted a test-negative design study in hospitalised children 1–17 years old admitted with recent-onset (≤5 days) acute respiratory illness in two large public hospitals in Hong Kong during successive SARS-CoV-2 epidemic waves between April 2022 and February 2024 dominated by the Omicron variant. We defined having been vaccinated as receipt of ≥1 SARS-CoV-2 vaccine dose within six months prior to hospitalisation, and for a sensitivity analysis, within twelve months of hospitalisation. Children who had only received one dose of vaccine and had no prior infection were excluded. We estimated VE against laboratory-confirmed SARS-CoV-2 infection separately for 1–4-year-olds and 5–17-year-olds, by conditional logistic regression stratified by calendar time (week) and adjusted for potential confounders.</div></div><div><h3>Results</h3><div>There were 6308 patients. The proportion of the vaccinated within six months of hospitalisation differed significantly between cases and controls in all strata of the assessed individual sociodemographic/health-related characteristics in the 5–17-year-olds, and in 1–4-year-olds who had a chronic medical condition. Overall, VE was moderate for 1–4-year-olds [41% (23–56%)] and for 5–17-year-olds [54% (10–66%)]. VE was higher in those who had received a mRNA vaccine: 87% (0–98%) and 82% (59–92%) compared with a lower VE for those who had received an inactivated vaccine: 39% (17–54%) and 30% (−19–58%), respectively for 1–4-year-olds and 5–17-year-olds although with a higher degree of imprecision in the VE for mRNA in 1–4-year-olds. In both age groups, VE was higher for those who had had no previous SARS-CoV-2 infection compared with for those who had had a previous infection.</div></div><div><h3>Conclusions</h3><div>SARS-CoV-2 vaccines, particularly mRNA vaccines, provided substantial protection against paediatric COVID-19-associated hospitalisations in Hong Kong during two successive SARS-CoV-2 epidemic waves dominated by the Omicron variant.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128262"},"PeriodicalIF":4.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146039549","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}
Duck Hepatitis A Virus type 1 (DHAV-1) is a highly pathogenic virus that causes severe mortality in ducklings and results in substantial economic losses to the global duck industry. Live-attenuated DHAV vaccine remains one of the most effective strategies for controlling this disease. We developed a safe and effective live attenuated vaccine candidate E23-SP80 adapted to specific-pathogen-free (SPF) chicken embryos by serial passage of a field isolate. The E23-SP80 exhibited an adaptive growth capacity in SPF chicken embryos with a viral titer of 107.25 ELD50/0.2 mL and lost its pathogenicity in 2-day-old Cherry Valley ducklings. The vaccine strain maintained its attenuation and showed no virulence reversion after back propagation into 2-day-old ducklings for five rounds. An immunizing dose of only 103.0 ELD₅₀ of E23-SP80 could provide 100% protection against challenge with lethal parental DHAV-1 strain. After a single intramuscular vaccination, virus-neutralizing antibody titers exceeded 9 log2 from 7 to 28 days post-vaccination and the titers were markedly higher than those of a commercial vaccine. Genomic analysis of E23-SP9 and E23-SP80 revealed fifteen amino acid substitutions, most of which were located in VP1 and 2A2 proteins, and the hypervariable region of VP1 (T180I and D193N) might contribute to attenuation. These results suggest that E23-SP80 strain is a promising commercial vaccine candidate for the prevention and control of DHAV-1 infection.
{"title":"Development of duck hepatitis A virus type 1 attenuated vaccine E23-SP80 and its protective efficacy evaluation against DHAV-1 infection in ducks","authors":"Jiajia Li, Phoo Eikari Kyaw, Chanjuan Tan, Kairui Wen, Jiabin Zhang, Yichen Tian, Dengfei Feng, Wenjian Liu, Shuhui Liu, Suquan Song, Liping Yan","doi":"10.1016/j.vaccine.2026.128258","DOIUrl":"10.1016/j.vaccine.2026.128258","url":null,"abstract":"<div><div>Duck Hepatitis A Virus type 1 (DHAV-1) is a highly pathogenic virus that causes severe mortality in ducklings and results in substantial economic losses to the global duck industry. Live-attenuated DHAV vaccine remains one of the most effective strategies for controlling this disease. We developed a safe and effective live attenuated vaccine candidate E23-SP80 adapted to specific-pathogen-free (SPF) chicken embryos by serial passage of a field isolate. The E23-SP80 exhibited an adaptive growth capacity in SPF chicken embryos with a viral titer of 10<sup>7.25</sup> ELD<sub>50</sub>/0.2 mL and lost its pathogenicity in 2-day-old Cherry Valley ducklings. The vaccine strain maintained its attenuation and showed no virulence reversion after back propagation into 2-day-old ducklings for five rounds. An immunizing dose of only 10<sup>3.0</sup> ELD₅₀ of E23-SP80 could provide 100% protection against challenge with lethal parental DHAV-1 strain. After a single intramuscular vaccination, virus-neutralizing antibody titers exceeded 9 log<sub>2</sub> from 7 to 28 days post-vaccination and the titers were markedly higher than those of a commercial vaccine. Genomic analysis of E23-SP9 and E23-SP80 revealed fifteen amino acid substitutions, most of which were located in VP1 and 2A2 proteins, and the hypervariable region of VP1 (T180I and D193N) might contribute to attenuation. These results suggest that E23-SP80 strain is a promising commercial vaccine candidate for the prevention and control of DHAV-1 infection.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128258"},"PeriodicalIF":4.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038941","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}
Pub Date : 2026-01-23DOI: 10.1016/j.vaccine.2026.128274
Megan E. Mansfield , Lillian Okui , Selebaleng Simon , Divya Hosangadi , Milton Montebatsi , Kaizer Ikgopoleng , Lesego Kuate , Basego Mothowaeng , Nessa Ryan , Daiva Yee , Melissa Dahlke , Kristen A. Stafford , Ndwapi Ndwapi , Abia Sebaka , Stacie M. Greby
Background
In 2022, despite initial coverage data indicating good acceptance of the vaccine by eligible groups, COVID-19 vaccination coverage in Botswana was below the Ministry of Health's goal of 80%, with underlying reasons unclear. Therefore, we conducted a study to identify facilitators and barriers to COVID-19 vaccination to inform the design and implementation of a toolkit to improve COVID-19 vaccination rates.
Methods
We conducted a sequential two-phased exploratory mixed methods study: Phase 1 (toolkit development and refinement) followed by Phase 2 (toolkit implementation and evaluation). Phase 1 involved two rounds of focus group discussions (FGDs) with general population and health care providers from various regions, followed by thematic analysis. Round 1 (32 FGDs, n = 298) aimed to identify facilitators and barriers to vaccination, while Round 2 (10 FGDs, n = 86) provided feedback to refine the toolkit. Phase 2 included training across 14 districts and evaluated knowledge and competence of vaccine providers (n = 92) through electronic pre-post questionnaires and Wilcoxon Signed-Rank Tests to assess differences.
Results
Facilitators of vaccination included access to accurate and trusted information as well as realistic expectations about vaccine benefits and side effects. Barriers included misinformation, lack of access to trusted information, difficulty accessing vaccines, and concerns about side effects. The toolkit content was tailored to the local context for providers and the public. Feedback indicated the toolkit was informative and helpful, with recommendations to add information on booster doses, vaccinating adolescents, and additional visuals, while limiting referrals to external information sources. Post-training assessments showed improvements in vaccine-related knowledge (Z = 221, p < 0.001) and competence in vaccine care and counseling (Z = 22, p < 0.001). Participants showed increased knowledge (Z = 292, p < 0.01) and competence (Z = 77, p < 0.001) in motivational interviewing.
Conclusion
Engagement with general public and providers in Botswana informed the design of an evidence-based, culturally appropriate toolkit and training that effectively improved vaccine knowledge and provider competence.
2022年，尽管初步覆盖率数据表明符合条件的人群对疫苗的接受程度良好，但博茨瓦纳的COVID-19疫苗接种覆盖率仍低于卫生部80%的目标，其根本原因尚不清楚。因此，我们开展了一项研究，以确定COVID-19疫苗接种的促进因素和障碍，为设计和实施提高COVID-19疫苗接种率的工具包提供信息。方法我们进行了连续两阶段的探索性混合方法研究：第一阶段（工具包开发和改进），第二阶段（工具包实施和评估）。第一阶段涉及两轮焦点小组讨论，对象是来自不同地区的普通民众和保健提供者，随后进行专题分析。第1轮（32个fgd， n = 298）旨在确定疫苗接种的促进因素和障碍，而第2轮（10个fgd， n = 86）提供反馈以完善工具包。第二阶段包括在14个地区进行培训，并通过电子事后问卷和Wilcoxon签名秩检验评估疫苗提供者的知识和能力（n = 92）。结果疫苗接种的促进因素包括获得准确和可信的信息以及对疫苗益处和副作用的现实期望。障碍包括错误信息、无法获得可信信息、难以获得疫苗以及对副作用的担忧。工具包内容针对提供者和公众的本地环境进行了定制。反馈表明，该工具包内容丰富、有益，并建议增加关于加强剂量、青少年接种疫苗的信息和额外的视觉效果，同时限制转诊到外部信息来源。培训后评估显示疫苗相关知识（Z = 221, p < 0.001）和疫苗护理和咨询能力（Z = 22, p < 0.001）有所改善。参与者在动机访谈中表现出知识（Z = 292, p < 0.01）和能力（Z = 77, p < 0.001）的提高。结论博茨瓦纳与公众和提供者的接触为设计循证、文化上适当的工具包和培训提供了信息，有效地提高了疫苗知识和提供者能力。
{"title":"Understanding COVID-19 vaccination choices and development of a toolkit and training for Botswana, 2022–2023","authors":"Megan E. Mansfield , Lillian Okui , Selebaleng Simon , Divya Hosangadi , Milton Montebatsi , Kaizer Ikgopoleng , Lesego Kuate , Basego Mothowaeng , Nessa Ryan , Daiva Yee , Melissa Dahlke , Kristen A. Stafford , Ndwapi Ndwapi , Abia Sebaka , Stacie M. Greby","doi":"10.1016/j.vaccine.2026.128274","DOIUrl":"10.1016/j.vaccine.2026.128274","url":null,"abstract":"<div><h3>Background</h3><div>In 2022, despite initial coverage data indicating good acceptance of the vaccine by eligible groups, COVID-19 vaccination coverage in Botswana was below the Ministry of Health's goal of 80%, with underlying reasons unclear. Therefore, we conducted a study to identify facilitators and barriers to COVID-19 vaccination to inform the design and implementation of a toolkit to improve COVID-19 vaccination rates.</div></div><div><h3>Methods</h3><div>We conducted a sequential two-phased exploratory mixed methods study: Phase 1 (toolkit development and refinement) followed by Phase 2 (toolkit implementation and evaluation). Phase 1 involved two rounds of focus group discussions (FGDs) with general population and health care providers from various regions, followed by thematic analysis. Round 1 (32 FGDs, <em>n</em> = 298) aimed to identify facilitators and barriers to vaccination, while Round 2 (10 FGDs, <em>n</em> = 86) provided feedback to refine the toolkit. Phase 2 included training across 14 districts and evaluated knowledge and competence of vaccine providers (<em>n</em> = 92) through electronic pre-post questionnaires and Wilcoxon Signed-Rank Tests to assess differences.</div></div><div><h3>Results</h3><div>Facilitators of vaccination included access to accurate and trusted information as well as realistic expectations about vaccine benefits and side effects. Barriers included misinformation, lack of access to trusted information, difficulty accessing vaccines, and concerns about side effects. The toolkit content was tailored to the local context for providers and the public. Feedback indicated the toolkit was informative and helpful, with recommendations to add information on booster doses, vaccinating adolescents, and additional visuals, while limiting referrals to external information sources. Post-training assessments showed improvements in vaccine-related knowledge (Z = 221, <em>p</em> < 0.001) and competence in vaccine care and counseling (Z = 22, <em>p</em> < 0.001). Participants showed increased knowledge (Z = 292, <em>p</em> < 0.01) and competence (Z = 77, p < 0.001) in motivational interviewing.</div></div><div><h3>Conclusion</h3><div>Engagement with general public and providers in Botswana informed the design of an evidence-based, culturally appropriate toolkit and training that effectively improved vaccine knowledge and provider competence.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128274"},"PeriodicalIF":4.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146039537","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}
Pub Date : 2026-01-23DOI: 10.1016/j.vaccine.2026.128257
William P. Hausdorff , Marco Cavaleri , Marion F. Gruber , Kwasi A. Nyarko , Andrew J. Pollard , Mateusz Hasso-Agopsowicz , Julie Joseph , Rakesh Aggarwal , Ernest Agyei-Kwame , Peter M. Dull , Pieter Neels , Hugues H. Bogaerts , Christopher J. Gill , Nancy Salts , Wenxi Tang , Birgitte K. Giersing
Combination vaccine formulations contain distinct components targeting multiple strains of a single pathogen or multiple pathogens. By minimizing the number of separate vaccine administrations required, combination vaccines have been critical in allowing the broad expansion of the number and range of diseases that can now be prevented by immunization. Recent advances in vaccine development and our understanding of the immune system now make it possible to envision how new combination vaccines could play a major role in helping immunization programs address a much wider range of emerging or still problematic pathogens. However, few combinations are currently in the pipeline, in part due to their inherently increased complexity and cost of development compared to standalone formulations. This complexity, in turn, is partly driven by the regulatory requirements surrounding the clinical study program for the combination vaccine, especially the primary clinical endpoints and the required degree of precision around those endpoints, as these ultimately determine the sample size, cost, and duration of the study. As part of a larger effort to facilitate combination vaccine development, vaccine experts at the World Health Organization and PATH coordinated a one-day meeting in March 2025 gathering current and former national regulatory agency staff from a dozen countries, together with vaccine developers, representatives from funding and procurement agencies, and public health and policy officials. The convened participants held spirited discussions on how multiple immune markers and controlled human infection models (CHIM) might contribute to the demonstration of vaccine efficacy. In addition, participants considered the possibility of relying on clinical endpoints when the vaccine components are directed against pathogens causing the same disease syndrome but etiological determination of each component's contribution is not feasible. Regulators welcomed scientifically sound, creative proposals for demonstration of efficacy, and agreed that the benefit-risk of the combination vaccine as a whole should be the primary focus.
{"title":"Report of a one-day convening on regulatory science, practices, and innovative approaches to facilitate approval of novel combination vaccines","authors":"William P. Hausdorff , Marco Cavaleri , Marion F. Gruber , Kwasi A. Nyarko , Andrew J. Pollard , Mateusz Hasso-Agopsowicz , Julie Joseph , Rakesh Aggarwal , Ernest Agyei-Kwame , Peter M. Dull , Pieter Neels , Hugues H. Bogaerts , Christopher J. Gill , Nancy Salts , Wenxi Tang , Birgitte K. Giersing","doi":"10.1016/j.vaccine.2026.128257","DOIUrl":"10.1016/j.vaccine.2026.128257","url":null,"abstract":"<div><div>Combination vaccine formulations contain distinct components targeting multiple strains of a single pathogen or multiple pathogens. By minimizing the number of separate vaccine administrations required, combination vaccines have been critical in allowing the broad expansion of the number and range of diseases that can now be prevented by immunization. Recent advances in vaccine development and our understanding of the immune system now make it possible to envision how new combination vaccines could play a major role in helping immunization programs address a much wider range of emerging or still problematic pathogens. However, few combinations are currently in the pipeline, in part due to their inherently increased complexity and cost of development compared to standalone formulations. This complexity, in turn, is partly driven by the regulatory requirements surrounding the clinical study program for the combination vaccine, especially the primary clinical endpoints and the required degree of precision around those endpoints, as these ultimately determine the sample size, cost, and duration of the study. As part of a larger effort to facilitate combination vaccine development, vaccine experts at the World Health Organization and PATH coordinated a one-day meeting in March 2025 gathering current and former national regulatory agency staff from a dozen countries, together with vaccine developers, representatives from funding and procurement agencies, and public health and policy officials. The convened participants held spirited discussions on how multiple immune markers and controlled human infection models (CHIM) might contribute to the demonstration of vaccine efficacy. In addition, participants considered the possibility of relying on clinical endpoints when the vaccine components are directed against pathogens causing the same disease syndrome but etiological determination of each component's contribution is not feasible. Regulators welcomed scientifically sound, creative proposals for demonstration of efficacy, and agreed that the benefit-risk of the combination vaccine as a whole should be the primary focus.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128257"},"PeriodicalIF":4.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146039488","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}
Pub Date : 2026-01-22DOI: 10.1016/j.vaccine.2025.128187
Robyn Stuart , Nicolas Theopold , Naomi Miall , Emily Kobayashi , Sara Vernam , Tanjila Taskin , Peter M. Dull
Background
Over 2023 and 2024, 19 of the countries that were supported by Gavi to purchase HPV vaccines adopted a single-dose HPV vaccination schedule. The goal of this study is to estimate the impact on vaccination access and the number of cervical cancers averted compared to a two-dose schedule.
Methods
We estimated the population that could be targeted in countries supported by Gavi to purchase HPV vaccines. We used UNICEF shipment plans to identify the number of HPV doses shipped to each country in 2023 and 2024, plus information supplied by Gavi on the dose schedule implemented in each country and year, adjusting for vaccine wastage. We computed the number of girls that could have been reached, first assuming complete utilization of all shipped doses under a single-dose schedule, and second assuming a counterfactual scenario where all countries would have used a 2-dose schedule. We then compared this to country-reported data on the number of girls actually vaccinated. For each of the three scenarios we modeled the number of cervical cancers averted using HPVsim, a microsimulation model calibrated to each country.
Findings
We calculate that the introduction of single-dose HPV vaccination in Gavi-supported countries would have allowed these countries to target 23.3M additional girls if all supply was utilized. Reported data on girls vaccinated indicates that in actuality an additional 18.5M girls were reached due to adoption of single-dose. We estimate that the use of single-dose schedule in 2023 and 2024 could have averted up to 370,000 (356,000–376,000) additional future cervical cancers if all supply had been utilized, and 297,000 (222,000–369,000) given actual utilization.
Interpretation
The single-dose HPV vaccination strategy has had a substantial positive impact on cervical cancer elimination in context of supply constraints affecting low and middle-income countries.
{"title":"The role of HPV single-dose vaccination in expanding access in GAVI-supported countries during a period of supply constraints","authors":"Robyn Stuart , Nicolas Theopold , Naomi Miall , Emily Kobayashi , Sara Vernam , Tanjila Taskin , Peter M. Dull","doi":"10.1016/j.vaccine.2025.128187","DOIUrl":"10.1016/j.vaccine.2025.128187","url":null,"abstract":"<div><h3>Background</h3><div>Over 2023 and 2024, 19 of the countries that were supported by Gavi to purchase HPV vaccines adopted a single-dose HPV vaccination schedule. The goal of this study is to estimate the impact on vaccination access and the number of cervical cancers averted compared to a two-dose schedule.</div></div><div><h3>Methods</h3><div>We estimated the population that could be targeted in countries supported by Gavi to purchase HPV vaccines. We used UNICEF shipment plans to identify the number of HPV doses shipped to each country in 2023 and 2024, plus information supplied by Gavi on the dose schedule implemented in each country and year, adjusting for vaccine wastage. We computed the number of girls that could have been reached, first assuming complete utilization of all shipped doses under a single-dose schedule, and second assuming a counterfactual scenario where all countries would have used a 2-dose schedule. We then compared this to country-reported data on the number of girls actually vaccinated. For each of the three scenarios we modeled the number of cervical cancers averted using HPVsim, a microsimulation model calibrated to each country.</div></div><div><h3>Findings</h3><div>We calculate that the introduction of single-dose HPV vaccination in Gavi-supported countries would have allowed these countries to target 23.3M additional girls if all supply was utilized. Reported data on girls vaccinated indicates that in actuality an additional 18.5M girls were reached due to adoption of single-dose. We estimate that the use of single-dose schedule in 2023 and 2024 could have averted up to 370,000 (356,000–376,000) additional future cervical cancers if all supply had been utilized, and 297,000 (222,000–369,000) given actual utilization.</div></div><div><h3>Interpretation</h3><div>The single-dose HPV vaccination strategy has had a substantial positive impact on cervical cancer elimination in context of supply constraints affecting low and middle-income countries.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128187"},"PeriodicalIF":4.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038943","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}
Pub Date : 2026-01-22DOI: 10.1016/j.vaccine.2026.128265
Florence Anne Barbey , Maria Otth , Sabine Kroiss , Daniel Drozdov , Christoph Berger
Background
Childhood cancer diagnosis and treatment cause significant immunosuppression, increasing vulnerability to vaccine-preventable diseases and disrupting routine vaccination schedules. In Switzerland, vaccination guidelines to support physicians caring for these patients were published in 2022. Adherence to these recommendations among pediatric cancer patients remains unknown.
Methods
We conducted a retrospective chart review of pediatric cancer patients (0–16 years at diagnosis) treated at two Swiss tertiary care centers between June 2022 and November 2024. Vaccine uptake was assessed at diagnosis, during, and after treatment using descriptive analyses. Exploratory analyses evaluated risk factors for under-vaccination, and occurrence of vaccine-preventable diseases was documented.
Results
Among 105 participants (median age at diagnosis 7.6 years [IQR 2.7–12.9]), uptake of vaccines recommended during treatment was low (pneumococcal conjugate vaccine 5%, influenza vaccine 10%, COVID-19 vaccine 19%). Post-treatment vaccine uptake was delayed and insufficient, ranging from 0 to 41% within 0–3 months following recommendation date and from 15 to 76% thereafter, depending on the vaccine. Younger age at diagnosis was associated with complete post-treatment vaccine uptake (p = 0.03). Vaccine-preventable diseases, including COVID-19, influenza, varicella, herpes zoster, and pertussis, occurred in 30/105 participants (29%). Most vaccines during (82%), and all vaccines after treatment (100%), were administered in primary care.
Conclusion
In a setting where post-treatment vaccination relies exclusively on primary care and no structured in-hospital measures are set in place, vaccine uptake among pediatric cancer patients remained insufficient. Targeted strategies are needed to improve guidelines adherence and reduce the burden of vaccine-preventable diseases, particularly among older children.
{"title":"Adherence to national vaccination guidelines among pediatric cancer patients: a retrospective study from two tertiary care centers in Switzerland","authors":"Florence Anne Barbey , Maria Otth , Sabine Kroiss , Daniel Drozdov , Christoph Berger","doi":"10.1016/j.vaccine.2026.128265","DOIUrl":"10.1016/j.vaccine.2026.128265","url":null,"abstract":"<div><h3>Background</h3><div>Childhood cancer diagnosis and treatment cause significant immunosuppression, increasing vulnerability to vaccine-preventable diseases and disrupting routine vaccination schedules. In Switzerland, vaccination guidelines to support physicians caring for these patients were published in 2022. Adherence to these recommendations among pediatric cancer patients remains unknown.</div></div><div><h3>Methods</h3><div>We conducted a retrospective chart review of pediatric cancer patients (0–16 years at diagnosis) treated at two Swiss tertiary care centers between June 2022 and November 2024. Vaccine uptake was assessed at diagnosis, during, and after treatment using descriptive analyses. Exploratory analyses evaluated risk factors for under-vaccination, and occurrence of vaccine-preventable diseases was documented.</div></div><div><h3>Results</h3><div>Among 105 participants (median age at diagnosis 7.6 years [IQR 2.7–12.9]), uptake of vaccines recommended during treatment was low (pneumococcal conjugate vaccine 5%, influenza vaccine 10%, COVID-19 vaccine 19%). Post-treatment vaccine uptake was delayed and insufficient, ranging from 0 to 41% within 0–3 months following recommendation date and from 15 to 76% thereafter, depending on the vaccine. Younger age at diagnosis was associated with complete post-treatment vaccine uptake (<em>p</em> = 0.03). Vaccine-preventable diseases, including COVID-19, influenza, varicella, herpes zoster, and pertussis, occurred in 30/105 participants (29%). Most vaccines during (82%), and all vaccines after treatment (100%), were administered in primary care.</div></div><div><h3>Conclusion</h3><div>In a setting where post-treatment vaccination relies exclusively on primary care and no structured in-hospital measures are set in place, vaccine uptake among pediatric cancer patients remained insufficient. Targeted strategies are needed to improve guidelines adherence and reduce the burden of vaccine-preventable diseases, particularly among older children.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128265"},"PeriodicalIF":4.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146032253","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}
WHO recommends infiltration of category III bite wounds, and category II wounds in immunocompromised individuals, with rabies immunoglobulins (RIG) to neutralize the virus at the site of exposure. Dilution with sterile normal saline is advised to ensure adequate wound infiltration. However, data on the extent of dilution across various RIGs and rabies monoclonal antibodies (RmAbs), and their effectiveness are lacking. This study aimed to generate evidence on dilution practices and outcomes following full-dose infiltration.
Objectives
To review the dilution ratios of RIGs and RmAbs used for full-dose wound infiltration in routine practice, and assess the clinical outcomes of the exposed individuals.
Methods
A desk review was conducted on 223 animal bite cases managed at an Anti-Rabies Clinic, Bengaluru, India from January 2022 to December 2024. All animal bite victims received full-dose RIG or RmAb, diluted with normal saline as required for complete wound infiltration. Survival status was verified through telephonic follow-up.
Results
Of the 223 cases, 133 (60%) were males, 210 (94%) cases had dog bites, 71 (31.8%) had bite from suspect rabid animals.Among 210 cases who had dog bites, 65 (31%) were attributed to suspect rabid dogs. Dilution ratios reached up to 1:1 for HRIG, 1:5.4 for ERIG, 1:20.7 for Rabishield, and 1:8.2 for Twinrab. Special groups included one pregnant woman (Twinrab) and one woman on antiretroviral therapy (Rabishield). Survival was 100%, with no rabies cases observed during 6–42 months of follow-up.
Conclusion
Diluted RIGs and RmAbs were found to be effective in preventing rabies when used for adequate infiltration of multiple and severe animal bite wounds, supporting the feasibility and safety of dilution practices in real-world clinical settings.
{"title":"Effectiveness of rabies immunoglobulins and monoclonal antibodies infiltrated into animal bite wounds after dilution: Real-world evidence from an anti-rabies clinic in India","authors":"D.H. Ashwath Narayana , M.K. Poornima , C.M. Chiranthan , H.S. Ravish , Reeta S. Mani , Shrikrishna Isloor , R. Sharada , M.K. Sudarshan","doi":"10.1016/j.vaccine.2026.128233","DOIUrl":"10.1016/j.vaccine.2026.128233","url":null,"abstract":"<div><h3>Background</h3><div>WHO recommends infiltration of category III bite wounds, and category II wounds in immunocompromised individuals, with rabies immunoglobulins (RIG) to neutralize the virus at the site of exposure. Dilution with sterile normal saline is advised to ensure adequate wound infiltration. However, data on the extent of dilution across various RIGs and rabies monoclonal antibodies (RmAbs), and their effectiveness are lacking. This study aimed to generate evidence on dilution practices and outcomes following full-dose infiltration.</div></div><div><h3>Objectives</h3><div>To review the dilution ratios of RIGs and RmAbs used for full-dose wound infiltration in routine practice, and assess the clinical outcomes of the exposed individuals.</div></div><div><h3>Methods</h3><div>A desk review was conducted on 223 animal bite cases managed at an Anti-Rabies Clinic, Bengaluru, India from January 2022 to December 2024. All animal bite victims received full-dose RIG or RmAb, diluted with normal saline as required for complete wound infiltration. Survival status was verified through telephonic follow-up.</div></div><div><h3>Results</h3><div>Of the 223 cases, 133 (60%) were males, 210 (94%) cases had dog bites, 71 (31.8%) had bite from suspect rabid animals.Among 210 cases who had dog bites, 65 (31%) were attributed to suspect rabid dogs. Dilution ratios reached up to 1:1 for HRIG, 1:5.4 for ERIG, 1:20.7 for Rabishield, and 1:8.2 for Twinrab. Special groups included one pregnant woman (Twinrab) and one woman on antiretroviral therapy (Rabishield). Survival was 100%, with no rabies cases observed during 6–42 months of follow-up.</div></div><div><h3>Conclusion</h3><div>Diluted RIGs and RmAbs were found to be effective in preventing rabies when used for adequate infiltration of multiple and severe animal bite wounds, supporting the feasibility and safety of dilution practices in real-world clinical settings.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128233"},"PeriodicalIF":4.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038944","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}
Pub Date : 2026-01-22DOI: 10.1016/j.vaccine.2026.128269
G. Tembo , D. Hoving , A.C. de Kroon , L. Chimgoneko , T. Nthandira , B. Galafa , F. Thole , E. Nsomba , D. Dula , C. Ngoliwa , N. Toto , L. Makhaza , A. Muyaya , E. Kudowa , A.E. Chirwa , M.Y.R. Henrion , T. Chikaonda , B.C. Urban , D.M. Ferreira , K.C. Jambo , S.B. Gordon
Pneumococcal conjugate vaccine (PCV13) introduction has reduced vaccine-type carriage and disease; however pneumococcal carriage persists at high rates particularly in high-transmission settings. Serotype 3 remains a particular problem in Malawi and globally, with high carriage rates, as well as strain resistance to antibiotics and antibody-mediated killing. We studied antibody and B cell responses to PCV13 in 65 healthy Malawian adults (18–40 years) taking part in a randomized controlled trial. Serum, nasal fluid, and PBMC samples were collected before and after vaccination. Anti-capsular IgG for serotypes 3 and 6B were measured by ELISA, and capsule-specific B cells were assessed by spectral flow cytometry. PCV13 increased both serum and mucosal IgG levels, and IgG+ B cells in blood for serotype 6B but not serotype 3. The poor immunogenicity of serotype 3 capsular polysaccharide in Malawian young adults highlights the need for alternative vaccines to address persistent serotype 3 carriage and disease.
{"title":"13-valent pneumococcal conjugate vaccine-induced B cells produce serotype 6B but not serotype 3 capsule-specific IgG antibodies in young Malawian adults","authors":"G. Tembo , D. Hoving , A.C. de Kroon , L. Chimgoneko , T. Nthandira , B. Galafa , F. Thole , E. Nsomba , D. Dula , C. Ngoliwa , N. Toto , L. Makhaza , A. Muyaya , E. Kudowa , A.E. Chirwa , M.Y.R. Henrion , T. Chikaonda , B.C. Urban , D.M. Ferreira , K.C. Jambo , S.B. Gordon","doi":"10.1016/j.vaccine.2026.128269","DOIUrl":"10.1016/j.vaccine.2026.128269","url":null,"abstract":"<div><div>Pneumococcal conjugate vaccine (PCV13) introduction has reduced vaccine-type carriage and disease; however pneumococcal carriage persists at high rates particularly in high-transmission settings. Serotype 3 remains a particular problem in Malawi and globally, with high carriage rates, as well as strain resistance to antibiotics and antibody-mediated killing. We studied antibody and B cell responses to PCV13 in 65 healthy Malawian adults (18–40 years) taking part in a randomized controlled trial. Serum, nasal fluid, and PBMC samples were collected before and after vaccination. Anti-capsular IgG for serotypes 3 and 6B were measured by ELISA, and capsule-specific B cells were assessed by spectral flow cytometry. PCV13 increased both serum and mucosal IgG levels, and IgG<sup>+</sup> B cells in blood for serotype 6B but not serotype 3. The poor immunogenicity of serotype 3 capsular polysaccharide in Malawian young adults highlights the need for alternative vaccines to address persistent serotype 3 carriage and disease.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128269"},"PeriodicalIF":4.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146039548","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}
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