Pub Date : 2026-02-17DOI: 10.1016/j.vaccine.2025.128166
Adam Soble, Mitsuki Koh, Jessica Taaffe, Simon R Procter, Rosalind M Eggo, Stefano Malvolti, Mark Jit, Shoshanna Goldin, Naor Bar-Zeev, Joseph Bresee, Philipp Lambach
Seasonal influenza remains a significant global public health challenge, causing substantial morbidity and mortality each year and there remains a need for more effective and durable influenza vaccines. To direct and accelerate research efforts, a full value of vaccine assessment (FVVA) was initiated to quantify the value of next-generation, improved influenza vaccines and identify key challenges that may limit their uptake once available. The FVVA utilized a mixed-methods approach with rapid assessment of literature, stakeholder interviews, and surveys, and quantitative data analysis to estimate the full value of influenza vaccines with improved characteristics. These analyses found that if improved influenza vaccines are broadly employed, depending on their characteristics, using our demand forecast they could avert 6.6-18 billion additional influenza cases, 2.3-6.2 million additional influenza deaths, and 21-57 million disability-adjusted life years (DALYs) between 2025 and 2050 beyond those averted by current seasonal influenza vaccines. Under this scenario, introducing improved influenza vaccines could be cost-effective in 9-48 % of countries at the lowest assumed price point. However, uncertainties about price and future vaccine coverage may impact the potential cost-effectiveness. Furthermore, from the producer perspective, the FVVA highlighted the robust financial value proposition to develop and commercialize improved influenza vaccines, in both established and emerging markets. Strongly tiered prices could make these vaccines cost-effective in more countries and boost impact further. To ensure that improved influenza vaccines achieve the greatest public health benefit, effective collaboration between vaccine developers, vaccine manufacturers, donors, financiers, multilateral organisations, and policy- and decision-makers will be essential.
{"title":"Evaluating the broader impact of improved influenza vaccines: A full value of vaccine assessment approach.","authors":"Adam Soble, Mitsuki Koh, Jessica Taaffe, Simon R Procter, Rosalind M Eggo, Stefano Malvolti, Mark Jit, Shoshanna Goldin, Naor Bar-Zeev, Joseph Bresee, Philipp Lambach","doi":"10.1016/j.vaccine.2025.128166","DOIUrl":"https://doi.org/10.1016/j.vaccine.2025.128166","url":null,"abstract":"<p><p>Seasonal influenza remains a significant global public health challenge, causing substantial morbidity and mortality each year and there remains a need for more effective and durable influenza vaccines. To direct and accelerate research efforts, a full value of vaccine assessment (FVVA) was initiated to quantify the value of next-generation, improved influenza vaccines and identify key challenges that may limit their uptake once available. The FVVA utilized a mixed-methods approach with rapid assessment of literature, stakeholder interviews, and surveys, and quantitative data analysis to estimate the full value of influenza vaccines with improved characteristics. These analyses found that if improved influenza vaccines are broadly employed, depending on their characteristics, using our demand forecast they could avert 6.6-18 billion additional influenza cases, 2.3-6.2 million additional influenza deaths, and 21-57 million disability-adjusted life years (DALYs) between 2025 and 2050 beyond those averted by current seasonal influenza vaccines. Under this scenario, introducing improved influenza vaccines could be cost-effective in 9-48 % of countries at the lowest assumed price point. However, uncertainties about price and future vaccine coverage may impact the potential cost-effectiveness. Furthermore, from the producer perspective, the FVVA highlighted the robust financial value proposition to develop and commercialize improved influenza vaccines, in both established and emerging markets. Strongly tiered prices could make these vaccines cost-effective in more countries and boost impact further. To ensure that improved influenza vaccines achieve the greatest public health benefit, effective collaboration between vaccine developers, vaccine manufacturers, donors, financiers, multilateral organisations, and policy- and decision-makers will be essential.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"60 Suppl 2 ","pages":"128166"},"PeriodicalIF":3.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-17DOI: 10.1016/j.vaccine.2026.128356
Mark A Green, Caroline Jeffery, Christopher Cheyne, Laura Bonnett, Marta Garcia-Finana, David M Hughes, Iain Buchan, Neil French, Daniel Hungerford
Introduction: Influenza and influenza-like illness (ILI) place a heavy burden on UK healthcare. Vaccination programmes are shown to be effective but impeded by socioeconomic and demographic inequalities in uptake and outcomes. This paper examines why some neighbourhoods show atypical patterns of vaccination and illness beyond just deprivation.
Methods: Electronic health records covering influenza seasons between 2018 and 19 to 2023-24 were used to explore trends in influenza vaccination and ILI among adults aged 50+ years. Multi-level negative binomial regression models were used to examine how vaccination uptake and neighbourhood-level deprivation were associated with ILI admissions, as well as to identify outlier neighbourhoods, which were further profiled.
Results: Most ILI hospital admissions occurred among adults aged 75+. Higher vaccination coverage was linked to fewer admissions, although this association weakened after adjusting for neighbourhood deprivation, which itself showed a strong social gradient with more deprived areas experiencing two to three times higher admission rates. Vaccination uptake was consistently lower in more deprived areas, with the steepest declines in uptake seen in younger age groups during 2023-24. The temporary provision of universal access of vaccinations for the 50-64 age group between 2020 and 21 and 2022-23 was associated with the largest increases in the least deprived areas. Additional neighbourhood factors predicted little of the residual variation in ILI beyond deprivation, though communal establishments, distance to nearest general practice and older housing showed some associations.
Conclusions: Reducing influenza harms will require both boosting vaccination uptake in disadvantaged communities and addressing the wider structural determinants of health.
{"title":"Learning from the outliers: A longitudinal ecological study of social and spatial inequalities in older adult influenza vaccination and hospitalisation (Cheshire and Merseyside, UK, 2018-19 to 2023-24).","authors":"Mark A Green, Caroline Jeffery, Christopher Cheyne, Laura Bonnett, Marta Garcia-Finana, David M Hughes, Iain Buchan, Neil French, Daniel Hungerford","doi":"10.1016/j.vaccine.2026.128356","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128356","url":null,"abstract":"<p><strong>Introduction: </strong>Influenza and influenza-like illness (ILI) place a heavy burden on UK healthcare. Vaccination programmes are shown to be effective but impeded by socioeconomic and demographic inequalities in uptake and outcomes. This paper examines why some neighbourhoods show atypical patterns of vaccination and illness beyond just deprivation.</p><p><strong>Methods: </strong>Electronic health records covering influenza seasons between 2018 and 19 to 2023-24 were used to explore trends in influenza vaccination and ILI among adults aged 50+ years. Multi-level negative binomial regression models were used to examine how vaccination uptake and neighbourhood-level deprivation were associated with ILI admissions, as well as to identify outlier neighbourhoods, which were further profiled.</p><p><strong>Results: </strong>Most ILI hospital admissions occurred among adults aged 75+. Higher vaccination coverage was linked to fewer admissions, although this association weakened after adjusting for neighbourhood deprivation, which itself showed a strong social gradient with more deprived areas experiencing two to three times higher admission rates. Vaccination uptake was consistently lower in more deprived areas, with the steepest declines in uptake seen in younger age groups during 2023-24. The temporary provision of universal access of vaccinations for the 50-64 age group between 2020 and 21 and 2022-23 was associated with the largest increases in the least deprived areas. Additional neighbourhood factors predicted little of the residual variation in ILI beyond deprivation, though communal establishments, distance to nearest general practice and older housing showed some associations.</p><p><strong>Conclusions: </strong>Reducing influenza harms will require both boosting vaccination uptake in disadvantaged communities and addressing the wider structural determinants of health.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"77 ","pages":"128356"},"PeriodicalIF":3.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-16DOI: 10.1016/j.vaccine.2026.128339
Nicole M Revie, Matthew Y Guo, Anne E Mullin, Jean-Louis Excler, Annelies Wilder-Smith, Calman A MacLennan, Jerome H Kim, Donald R Walkinshaw
Invasive non-typhoidal Salmonella disease represents a major public health challenge, particularly in sub-Saharan Africa, where it is a leading cause of community-acquired bloodstream infections. Despite its significant morbidity and mortality, no licensed vaccines exist. Recognizing this unmet need, multiple global health initiatives and targeted investments have advanced iNTS vaccine development. These efforts have advanced several promising candidates employing diverse platform technologies, including the first iNTS vaccine candidate to enter clinical trials in more than 15 years in 2019. To date, three additional candidates have entered clinical development-two progressing through Phase 2 trials and one currently in a Phase 1/2 study-while many more remain in preclinical development. Several candidates also incorporate antigens targeting Salmonella Typhi or Salmonella Paratyphi A alongside iNTS components to broaden coverage and expand market potential. Despite this progress, scientific, regulatory and commercial challenges persist. In response, global health organizations have intensified efforts to support vaccine development, clarify regulatory pathways and foster engagement with key decision-makers, including through the development of Preferred Product Characteristics and a Full Value of Vaccines Assessment. These coordinated efforts mark a significant step toward enabling and accelerating iNTS vaccine development, ultimately aiming to prevent iNTS disease and its associated health burden.
{"title":"The invasive non-typhoidal Salmonella vaccine landscape: Innovations and challenges ahead.","authors":"Nicole M Revie, Matthew Y Guo, Anne E Mullin, Jean-Louis Excler, Annelies Wilder-Smith, Calman A MacLennan, Jerome H Kim, Donald R Walkinshaw","doi":"10.1016/j.vaccine.2026.128339","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128339","url":null,"abstract":"<p><p>Invasive non-typhoidal Salmonella disease represents a major public health challenge, particularly in sub-Saharan Africa, where it is a leading cause of community-acquired bloodstream infections. Despite its significant morbidity and mortality, no licensed vaccines exist. Recognizing this unmet need, multiple global health initiatives and targeted investments have advanced iNTS vaccine development. These efforts have advanced several promising candidates employing diverse platform technologies, including the first iNTS vaccine candidate to enter clinical trials in more than 15 years in 2019. To date, three additional candidates have entered clinical development-two progressing through Phase 2 trials and one currently in a Phase 1/2 study-while many more remain in preclinical development. Several candidates also incorporate antigens targeting Salmonella Typhi or Salmonella Paratyphi A alongside iNTS components to broaden coverage and expand market potential. Despite this progress, scientific, regulatory and commercial challenges persist. In response, global health organizations have intensified efforts to support vaccine development, clarify regulatory pathways and foster engagement with key decision-makers, including through the development of Preferred Product Characteristics and a Full Value of Vaccines Assessment. These coordinated efforts mark a significant step toward enabling and accelerating iNTS vaccine development, ultimately aiming to prevent iNTS disease and its associated health burden.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"76 ","pages":"128339"},"PeriodicalIF":3.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146215351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-16DOI: 10.1016/j.vaccine.2026.128349
Hieu Cong Truong, Quang Duy Pham, Thanh Van Phan, Dai Thi Trang Vo, Phuc Duy Nguyen, Hung Thanh Nguyen, Nhan Nguyen Thanh Le, Tung Huu Trinh, Qui Dinh Nguyen, Nam Tran Nguyen, Trinh Tuyet Lam, Antoine Soetewey, Trung Vu Nguyen, Thuong Vu Nguyen, Niko Speybroeck
Background: Evidence on the effectiveness of pneumococcal conjugate vaccines (PCVs) in Vietnam remains limited, despite the availability of 10-valent (PCV10) and 13-valent (PCV13) conjugate vaccines in the private sector since 2014 and 2019. We evaluated the effectiveness of PCVs against invasive pneumococcal disease (IPD) among Vietnamese children prior to national introduction.
Methods: We conducted a matched case-control study between February 2022 and January 2025 in southern Vietnam. Cases were children aged 2-59 months hospitalized with culture-confirmed IPD from normally sterile sites at three tertiary pediatric hospitals. Four age- and neighborhood-matched community controls were enrolled per case. Vaccine effectiveness (VE) was estimated using conditional logistic regression as (1 - adjusted odds ratio) × 100%.
Results: We enrolled 72 IPD cases and 288 matched controls; 37.5% of cases had received ≥1 PCV dose. The most frequent clinical syndromes were meningitis (36.1%) and pneumonia-associated sepsis (30.6%). Serotype 19A predominated (26.4%), followed by 6A (13.9%) and 19F (11.1%); 77.8% of cases were caused by serotypes included in PCV13. For vaccine-type IPD (VT-IPD), adjusted VE of PCV10 against PCV10-type IPD was 86.3% (95% CI, 13.3-97.9) for ≥1 dose and 89.5% (95% CI, 16.1-98.7) for ≥2 doses; VE of PCV13 against PCV13-type IPD was similarly high. Against all-serotype IPD, adjusted VE was 65.1% (95% CI, 21.8-84.4) for ≥1 PCV10 dose and 84.4% (95% CI, 20.0-97.0) for ≥1 PCV13 dose. No significant effectiveness was observed against non-PCV10-type IPD. VE was highest against serotype 6 A and declined with increasing time since vaccination.
Conclusions: This first Vietnamese evidence demonstrates that PCV10 and PCV13 provide substantial protection against VT-IPD and overall IPD in young children despite low vaccine coverage. The predominance of serotype 19A and waning protection over time emphasize the importance of selecting 19A-containing formulations and booster schedules to inform timely national PCV introduction in Vietnam.
{"title":"Effectiveness of pneumococcal conjugate vaccines against invasive pneumococcal disease in Vietnamese children prior to national introduction: A matched case-control study.","authors":"Hieu Cong Truong, Quang Duy Pham, Thanh Van Phan, Dai Thi Trang Vo, Phuc Duy Nguyen, Hung Thanh Nguyen, Nhan Nguyen Thanh Le, Tung Huu Trinh, Qui Dinh Nguyen, Nam Tran Nguyen, Trinh Tuyet Lam, Antoine Soetewey, Trung Vu Nguyen, Thuong Vu Nguyen, Niko Speybroeck","doi":"10.1016/j.vaccine.2026.128349","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128349","url":null,"abstract":"<p><strong>Background: </strong>Evidence on the effectiveness of pneumococcal conjugate vaccines (PCVs) in Vietnam remains limited, despite the availability of 10-valent (PCV10) and 13-valent (PCV13) conjugate vaccines in the private sector since 2014 and 2019. We evaluated the effectiveness of PCVs against invasive pneumococcal disease (IPD) among Vietnamese children prior to national introduction.</p><p><strong>Methods: </strong>We conducted a matched case-control study between February 2022 and January 2025 in southern Vietnam. Cases were children aged 2-59 months hospitalized with culture-confirmed IPD from normally sterile sites at three tertiary pediatric hospitals. Four age- and neighborhood-matched community controls were enrolled per case. Vaccine effectiveness (VE) was estimated using conditional logistic regression as (1 - adjusted odds ratio) × 100%.</p><p><strong>Results: </strong>We enrolled 72 IPD cases and 288 matched controls; 37.5% of cases had received ≥1 PCV dose. The most frequent clinical syndromes were meningitis (36.1%) and pneumonia-associated sepsis (30.6%). Serotype 19A predominated (26.4%), followed by 6A (13.9%) and 19F (11.1%); 77.8% of cases were caused by serotypes included in PCV13. For vaccine-type IPD (VT-IPD), adjusted VE of PCV10 against PCV10-type IPD was 86.3% (95% CI, 13.3-97.9) for ≥1 dose and 89.5% (95% CI, 16.1-98.7) for ≥2 doses; VE of PCV13 against PCV13-type IPD was similarly high. Against all-serotype IPD, adjusted VE was 65.1% (95% CI, 21.8-84.4) for ≥1 PCV10 dose and 84.4% (95% CI, 20.0-97.0) for ≥1 PCV13 dose. No significant effectiveness was observed against non-PCV10-type IPD. VE was highest against serotype 6 A and declined with increasing time since vaccination.</p><p><strong>Conclusions: </strong>This first Vietnamese evidence demonstrates that PCV10 and PCV13 provide substantial protection against VT-IPD and overall IPD in young children despite low vaccine coverage. The predominance of serotype 19A and waning protection over time emphasize the importance of selecting 19A-containing formulations and booster schedules to inform timely national PCV introduction in Vietnam.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"77 ","pages":"128349"},"PeriodicalIF":3.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146215331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-15DOI: 10.1016/j.vaccine.2026.128348
Fei Heng, Craig A Magaret, Nadine G Rouphael, Angela R Branche, Youyi Fong, Lindsay N Carpp, Chenchen Yu, Shiyu Chen, Bo Zhang, David J Diemert, Ann R Falsey, Daniel S Graciaa, Lindsey R Baden, Sharon E Frey, Jennifer A Whitaker, Susan J Little, Satoshi Kamidani, Emmanuel B Walter, Richard M Novak, Richard Rupp, Lisa A Jackson, Tara M Babu, Angelica C Kottkamp, Anne F Luetkemeyer, Lilly C Immergluck, Rachel M Presti, Martín Bäcker, Patricia L Winokur, Siham M Mahgoub, Paul A Goepfert, Dahlene N Fusco, Robert L Atmar, Christine M Posavad, Jinjian Mu, Mat Makowski, Mamodikoe K Makhene, Seema U Nayak, Viviana Simon, Harm van Bakel, Paul C Roberts, Peter B Gilbert
In the Coronavirus Variant Immunologic Landscape Trial (COVAIL) conducted in the United States in 2022-2023, 985 participants received a second COVID-19 booster with one of twelve monovalent or bivalent mRNA inserts. Pseudovirus serum inhibitory dilution 50% neutralizing antibody titer (nAb titer) measured two-weeks post booster significantly associated with lower COVID-19 incidence over six months follow-up in this trial. COVAIL investigators sequenced SARS-CoV-2 Spike amino acid sequences for all COVID-19 cases, with a sequence successfully obtained from 129 of 195 cases. For COVID-19 endpoint cases we calculated five distances of the case-causing sequence to a reference sequence, the first two physico-chemical weighted Hamming distances of Spike or receptor binding domain (RBD) to a participant's nearest Spike or RBD vaccine-insert sequence, and the other three estimated degrees of neutralizing antibody escape from the XBB.1.5 RBD strain calculated with deep mutational scanning. Hypothesizing that the nAb titer correlate of risk may have a stronger association with COVID-19 when focusing on COVID-19 infections more closely matched to the vaccine insert in Spike or RBD amino acid sequence or with lower RBD antibody escape score, we tested this hypothesis for the combined group receiving a monovalent Prototype (ancestral strain) booster (n = 143) and for the combined group receiving an Omicron-containing booster (n = 744). For both combined groups, the nAb titer correlate of risk did not significantly vary across any of the assessed sequence distances from the vaccine insert (all p-values >0.10), although RBD Hamming distance had point estimates consistent with a weakening correlate with distance, motivating further exploration in settings with greater antigenic heterogeneity. Indeed, statistical power was bounded by the limited antigenic variability of viruses infecting trial participants over the follow-up period (April 21, 2022 to May 25, 2023), which spanned only a 3.02-fold nAb titer range of differential sensitivity to sera from XBB.1.5-infected individuals. ClinicalTrials.gov Identifier: NCT05289037.
{"title":"The neutralizing antibody titer correlate of COVID-19 risk in the COVID-19 variant immunologic landscape (COVAIL) trial was not modified by SARS-CoV-2 amino acid sequence distances.","authors":"Fei Heng, Craig A Magaret, Nadine G Rouphael, Angela R Branche, Youyi Fong, Lindsay N Carpp, Chenchen Yu, Shiyu Chen, Bo Zhang, David J Diemert, Ann R Falsey, Daniel S Graciaa, Lindsey R Baden, Sharon E Frey, Jennifer A Whitaker, Susan J Little, Satoshi Kamidani, Emmanuel B Walter, Richard M Novak, Richard Rupp, Lisa A Jackson, Tara M Babu, Angelica C Kottkamp, Anne F Luetkemeyer, Lilly C Immergluck, Rachel M Presti, Martín Bäcker, Patricia L Winokur, Siham M Mahgoub, Paul A Goepfert, Dahlene N Fusco, Robert L Atmar, Christine M Posavad, Jinjian Mu, Mat Makowski, Mamodikoe K Makhene, Seema U Nayak, Viviana Simon, Harm van Bakel, Paul C Roberts, Peter B Gilbert","doi":"10.1016/j.vaccine.2026.128348","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128348","url":null,"abstract":"<p><p>In the Coronavirus Variant Immunologic Landscape Trial (COVAIL) conducted in the United States in 2022-2023, 985 participants received a second COVID-19 booster with one of twelve monovalent or bivalent mRNA inserts. Pseudovirus serum inhibitory dilution 50% neutralizing antibody titer (nAb titer) measured two-weeks post booster significantly associated with lower COVID-19 incidence over six months follow-up in this trial. COVAIL investigators sequenced SARS-CoV-2 Spike amino acid sequences for all COVID-19 cases, with a sequence successfully obtained from 129 of 195 cases. For COVID-19 endpoint cases we calculated five distances of the case-causing sequence to a reference sequence, the first two physico-chemical weighted Hamming distances of Spike or receptor binding domain (RBD) to a participant's nearest Spike or RBD vaccine-insert sequence, and the other three estimated degrees of neutralizing antibody escape from the XBB.1.5 RBD strain calculated with deep mutational scanning. Hypothesizing that the nAb titer correlate of risk may have a stronger association with COVID-19 when focusing on COVID-19 infections more closely matched to the vaccine insert in Spike or RBD amino acid sequence or with lower RBD antibody escape score, we tested this hypothesis for the combined group receiving a monovalent Prototype (ancestral strain) booster (n = 143) and for the combined group receiving an Omicron-containing booster (n = 744). For both combined groups, the nAb titer correlate of risk did not significantly vary across any of the assessed sequence distances from the vaccine insert (all p-values >0.10), although RBD Hamming distance had point estimates consistent with a weakening correlate with distance, motivating further exploration in settings with greater antigenic heterogeneity. Indeed, statistical power was bounded by the limited antigenic variability of viruses infecting trial participants over the follow-up period (April 21, 2022 to May 25, 2023), which spanned only a 3.02-fold nAb titer range of differential sensitivity to sera from XBB.1.5-infected individuals. ClinicalTrials.gov Identifier: NCT05289037.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"76 ","pages":"128348"},"PeriodicalIF":3.5,"publicationDate":"2026-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146208595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-14DOI: 10.1016/j.vaccine.2026.128273
Matthias Helble, Claudia Nannei, Martin Friede, Martin W Nicholson
In an effort to improve pandemic preparedness and health security, many low- and middle-income countries (LMICs) have launched initiatives to expand regional vaccine manufacturing. A number of elements relating to vaccine markets, production, value chains, and ecosystems significantly impact the ability to generate economically viable and sustainable vaccine manufacturing in LMICs. This paper provides an overview of vaccine manufacturing characteristics and global vaccine markets dynamics. Establishing vaccine manufacturing is a complex undertaking due to a variety of factors including intense competition, associated uncertainty regarding the ability to capture market share and substantial capital investment requirements. Substantive government commitment and investment are essential to ensure new local entrants compete successfully. In the medium to long run, the role of government should shift from supporting individual firms to strengthening local science ecosystems as this bolsters economic sustainability in three ways. First, investment in science promotes technological advances which can reduce production costs, e.g., through process innovations for vaccine manufacturing. Second, strong science ecosystems help to address the skills gap faced by manufacturers. And third, strong science ecosystems enable research and development of new vaccines that address local unmet needs and open new markets. Furthermore, developing a regional approach to vaccine manufacturing and procurement, with associated regulatory harmonization, is crucial to achieving economically viable and distributed vaccine manufacturing. Importantly, investment in research and development and fostering of regional collaborations drives innovation, feeding into new product discovery and consequently a strong pipeline of new vaccine products, driving economically sustainable regional vaccine manufacturing. This offers the potential to prevent endemic infectious diseases with significant socioeconomic and health burden or to develop therapeutic vaccines, generating regular interpandemic demand for regional vaccine manufacturers, consequently sustaining capacity retention and associated pandemic preparedness.
{"title":"Pathways to economically viable and sustainable vaccine manufacturing in LMICs.","authors":"Matthias Helble, Claudia Nannei, Martin Friede, Martin W Nicholson","doi":"10.1016/j.vaccine.2026.128273","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128273","url":null,"abstract":"<p><p>In an effort to improve pandemic preparedness and health security, many low- and middle-income countries (LMICs) have launched initiatives to expand regional vaccine manufacturing. A number of elements relating to vaccine markets, production, value chains, and ecosystems significantly impact the ability to generate economically viable and sustainable vaccine manufacturing in LMICs. This paper provides an overview of vaccine manufacturing characteristics and global vaccine markets dynamics. Establishing vaccine manufacturing is a complex undertaking due to a variety of factors including intense competition, associated uncertainty regarding the ability to capture market share and substantial capital investment requirements. Substantive government commitment and investment are essential to ensure new local entrants compete successfully. In the medium to long run, the role of government should shift from supporting individual firms to strengthening local science ecosystems as this bolsters economic sustainability in three ways. First, investment in science promotes technological advances which can reduce production costs, e.g., through process innovations for vaccine manufacturing. Second, strong science ecosystems help to address the skills gap faced by manufacturers. And third, strong science ecosystems enable research and development of new vaccines that address local unmet needs and open new markets. Furthermore, developing a regional approach to vaccine manufacturing and procurement, with associated regulatory harmonization, is crucial to achieving economically viable and distributed vaccine manufacturing. Importantly, investment in research and development and fostering of regional collaborations drives innovation, feeding into new product discovery and consequently a strong pipeline of new vaccine products, driving economically sustainable regional vaccine manufacturing. This offers the potential to prevent endemic infectious diseases with significant socioeconomic and health burden or to develop therapeutic vaccines, generating regular interpandemic demand for regional vaccine manufacturers, consequently sustaining capacity retention and associated pandemic preparedness.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128273"},"PeriodicalIF":3.5,"publicationDate":"2026-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146204513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Following approval of the first Maternal RSV vaccine (MV) and long-acting monoclonal RSV antibody (la-mAbs) in Europe, several countries have begun integrating the products into their infant RSV immunization programs.
Methods: Based on a survey supplemented by policy documents, this paper provides a descriptive, policy-focused cross-sectional overview of RSV immunization strategies across 32 European countries.
Results: As of September 2025, 22 countries offered programmatic RSV prophylaxis for infants. Of these, 5 use only MV, 10 use only la-mAbs and 7 countries offer both. Considerable variation was observed in programmatic approaches with respect to (gestational) age of administration, delivery pathways, eligibility criteria for mothers and infants, and reimbursement mechanisms.
Conclusions: The RSV immunization policy landscape in Europe is diverse and dynamic, presenting both challenges and opportunities for shared learning and policy development.
{"title":"The evolving landscape of RSV immunization: Current policies and practices across Europe.","authors":"Zazie Franck, Sanne Hofstraat, Lotte Jonker, Leyla Kragten, Chiara Messina, Ricardo M Fernandes, Patricia Bruijning-Verhagen","doi":"10.1016/j.vaccine.2026.128222","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128222","url":null,"abstract":"<p><strong>Background: </strong>Following approval of the first Maternal RSV vaccine (MV) and long-acting monoclonal RSV antibody (la-mAbs) in Europe, several countries have begun integrating the products into their infant RSV immunization programs.</p><p><strong>Methods: </strong>Based on a survey supplemented by policy documents, this paper provides a descriptive, policy-focused cross-sectional overview of RSV immunization strategies across 32 European countries.</p><p><strong>Results: </strong>As of September 2025, 22 countries offered programmatic RSV prophylaxis for infants. Of these, 5 use only MV, 10 use only la-mAbs and 7 countries offer both. Considerable variation was observed in programmatic approaches with respect to (gestational) age of administration, delivery pathways, eligibility criteria for mothers and infants, and reimbursement mechanisms.</p><p><strong>Conclusions: </strong>The RSV immunization policy landscape in Europe is diverse and dynamic, presenting both challenges and opportunities for shared learning and policy development.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128222"},"PeriodicalIF":3.5,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146198359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-25Epub Date: 2025-12-07DOI: 10.1016/j.vaccine.2025.128040
Mona Askar, Karam Adel, Madeleine Batke, Yuan Chi, Lea Gorenflo, Anna Hayman Robertson, Kari Johansen, Jorgen de Jonge, Philipp Kapp, Tyra Grove Krause, Elizabeth Lynch, Joerg J Meerpohl, Angeliki Melidou, Hanna Nohynek, Carmen Olmedo, Kate Olsson, Ioanna Pavlopoulou, Jaime Jesús Pérez, Vanessa Piechotta, Catalina Hamon Pinilla, Johanna Rubin, Veronika Učakar, Julia Wilhelm, Ole Wichmann, Thomas Harder
Objectives: To investigate indirect vaccine effectiveness (indirVE) of vaccination of children and adolescents with seasonal influenza vaccines against influenza-related outcomes occurring in other population groups.
Methods: We performed a systematic review of studies (randomized and non-randomized) on indirVE of vaccination of participants aged 6 months-17 years with tri- or quadrivalent seasonal influenza vaccines against influenza (lab-confirmed; non-lab-confirmed) occurring in contacts of vaccinated persons or members of the wider community (last search: 17th March 2024). GRADE certainty of evidence (CoE) was evaluated (PROSPERO: CRD42024546400).
Results: We identified 28 studies (5 randomized; 23 non-randomized). In community-based studies, indirect protection against laboratory-confirmed influenza (LCI) ranged from -38 % [95 % CI: -574 to 72] to 61 % [95 % CI: 8-83] (very low CoE). In household-based settings, indirVE against LCI varied between -151.2 % [95 % CI: -1194.6 to 51.3] and 39.4 % [95 % CI: 7.4 to 60.3] (very low CoE). In school-based settings, highly variable indirect effects were observed on LCI, hospitalization, emergency department visits and school/work absenteeism (very low CoE).
Conclusions: There is no clear evidence of indirect effects from influenza vaccination in children. While plausible, effect size is uncertain and varies by study design, population, and vaccine type. Stronger indirect effects appeared only when direct VE was high.
{"title":"Population effects of influenza vaccination in children and adolescents: Systematic review.","authors":"Mona Askar, Karam Adel, Madeleine Batke, Yuan Chi, Lea Gorenflo, Anna Hayman Robertson, Kari Johansen, Jorgen de Jonge, Philipp Kapp, Tyra Grove Krause, Elizabeth Lynch, Joerg J Meerpohl, Angeliki Melidou, Hanna Nohynek, Carmen Olmedo, Kate Olsson, Ioanna Pavlopoulou, Jaime Jesús Pérez, Vanessa Piechotta, Catalina Hamon Pinilla, Johanna Rubin, Veronika Učakar, Julia Wilhelm, Ole Wichmann, Thomas Harder","doi":"10.1016/j.vaccine.2025.128040","DOIUrl":"10.1016/j.vaccine.2025.128040","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate indirect vaccine effectiveness (indirVE) of vaccination of children and adolescents with seasonal influenza vaccines against influenza-related outcomes occurring in other population groups.</p><p><strong>Methods: </strong>We performed a systematic review of studies (randomized and non-randomized) on indirVE of vaccination of participants aged 6 months-17 years with tri- or quadrivalent seasonal influenza vaccines against influenza (lab-confirmed; non-lab-confirmed) occurring in contacts of vaccinated persons or members of the wider community (last search: 17th March 2024). GRADE certainty of evidence (CoE) was evaluated (PROSPERO: CRD42024546400).</p><p><strong>Results: </strong>We identified 28 studies (5 randomized; 23 non-randomized). In community-based studies, indirect protection against laboratory-confirmed influenza (LCI) ranged from -38 % [95 % CI: -574 to 72] to 61 % [95 % CI: 8-83] (very low CoE). In household-based settings, indirVE against LCI varied between -151.2 % [95 % CI: -1194.6 to 51.3] and 39.4 % [95 % CI: 7.4 to 60.3] (very low CoE). In school-based settings, highly variable indirect effects were observed on LCI, hospitalization, emergency department visits and school/work absenteeism (very low CoE).</p><p><strong>Conclusions: </strong>There is no clear evidence of indirect effects from influenza vaccination in children. While plausible, effect size is uncertain and varies by study design, population, and vaccine type. Stronger indirect effects appeared only when direct VE was high.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"71 ","pages":"128040"},"PeriodicalIF":3.5,"publicationDate":"2026-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","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.2026.128272
Emily Jane Woo
{"title":"Adjuvanted recombinant zoster vaccine and live attenuated zoster vaccine are vastly different.","authors":"Emily Jane Woo","doi":"10.1016/j.vaccine.2026.128272","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.128272","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128272"},"PeriodicalIF":3.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146041987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-15DOI: 10.1016/j.vaccine.2025.127988
J M McLaughlin, J Wassil
{"title":"Response to Anticipated impact of novel adult-specific pneumococcal conjugate vaccine by Joshi et al.","authors":"J M McLaughlin, J Wassil","doi":"10.1016/j.vaccine.2025.127988","DOIUrl":"https://doi.org/10.1016/j.vaccine.2025.127988","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"127988"},"PeriodicalIF":3.5,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145531058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}