Pub Date : 2026-01-31DOI: 10.1016/j.vaccine.2026.128280
Katerina S. Cheliotis , Patricia Gonzalez-Dias , Esther L. German , André N.A. Gonçalves , Elena Mitsi , Elissavet Nikolaou , Sherin Pojar , Eliane N. Miyaji , Rafaella Tostes , Jesús Reiné , Andrea M. Collins , Helder I. Nakaya , Stephen B. Gordon , Ying-Jie Lu , Shaun H. Pennington , Andrew J. Pollard , Richard Malley , Simon P. Jochems , Britta Urban , Carla Solórzano , Daniela M. Ferreira
Identifying conserved, immunogenic proteins that confer protection against Streptococcus pneumoniae (pneumococcus) colonization could enable development of serotype-independent vaccines.
In our controlled human infection model, no individual IgG or cytokine/chemokine response correlated significantly with protection against colonization with pneumococcus, suggesting that effective immunity reflects a coordinated, multi-antigen response. To capture these complex patterns, we trained independent Random Forest models on humoral and cellular datasets. The humoral model identified IgG responses to PdB, SP1069, and SP0899 as predictive of protection. The cellular model revealed that MCP-1 responses to SP1069 and SP0899, and IL-17A production in response to SP0648-3, were associated with protection. Elevated baseline IFN-γ, RANTES, and anti-protein IgG levels were linked to reduced colonization density.
We highlight SP1069 and SP0899 as potential serotype-independent vaccine candidates and demonstrate the utility of machine learning to identify immune correlates of protection.
{"title":"Machine learning-driven identification of serotype-independent pneumococcal vaccine candidates using samples from human infection challenge studies","authors":"Katerina S. Cheliotis , Patricia Gonzalez-Dias , Esther L. German , André N.A. Gonçalves , Elena Mitsi , Elissavet Nikolaou , Sherin Pojar , Eliane N. Miyaji , Rafaella Tostes , Jesús Reiné , Andrea M. Collins , Helder I. Nakaya , Stephen B. Gordon , Ying-Jie Lu , Shaun H. Pennington , Andrew J. Pollard , Richard Malley , Simon P. Jochems , Britta Urban , Carla Solórzano , Daniela M. Ferreira","doi":"10.1016/j.vaccine.2026.128280","DOIUrl":"10.1016/j.vaccine.2026.128280","url":null,"abstract":"<div><div>Identifying conserved, immunogenic proteins that confer protection against <em>Streptococcus pneumoniae</em> (<em>pneumococcus</em>) colonization could enable development of serotype-independent vaccines.</div><div>In our controlled human infection model, no individual IgG or cytokine/chemokine response correlated significantly with protection against colonization with pneumococcus, suggesting that effective immunity reflects a coordinated, multi-antigen response. To capture these complex patterns, we trained independent Random Forest models on humoral and cellular datasets. The humoral model identified IgG responses to PdB, SP1069, and SP0899 as predictive of protection. The cellular model revealed that MCP-1 responses to SP1069 and SP0899, and IL-17A production in response to SP0648-3, were associated with protection. Elevated baseline IFN-γ, RANTES, and anti-protein IgG levels were linked to reduced colonization density.</div><div>We highlight SP1069 and SP0899 as potential serotype-independent vaccine candidates and demonstrate the utility of machine learning to identify immune correlates of protection.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128280"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101241","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128298
Moses Mwale
Background
Measles remains a leading vaccine-preventable killer in low- and middle-income countries (LMICs). Using the WHO/UNICEF Estimates of National Immunization Coverage (WUENIC) 2024 revisions, this article assesses measles-containing vaccine first-dose (MCV1) and second-dose (MCV2) coverage trends, inequities, and priority groups for targeted action.
Methods
Data from 2019 to 2024 for 137 LMICs were analysed using descriptive statistics; Welch's t-tests and Wilcoxon rank-sum tests to compare fragile versus non-fragile states; Gini coefficients for inequality; k-means clustering (k = 4) on coverage, MCV1-to-MCV2 dropout, change, unvaccinated counts, and fragility; and bounded linear models to project MCV1 to 2030.
Results
In 2024, mean MCV1 coverage was 79.2% (95% CI: 76.8–81.6)—below the 95% threshold—with fragile LMICs at 68.5% versus 87.4% in non-fragile LMICs (difference − 18.1 percentage points; p < 0.001). MCV2 gaps were larger (−26.9 percentage points; p < 0.001). DTP1-based zero-dose prevalence was 20.8%, with 15.6 million children unvaccinated for MCV1 and 22.4 million for MCV2; West and Central Africa accounted for 7.2 million MCV1-unvaccinated (46.2%). Inequality rose (Gini 0.22 → 0.25, 2019–2024). Projections indicate MCV1 of 84.2% by 2030, with fragile LMICs off-track. Clustering identified four profiles: (1) very low coverage, high dropout, high fragility (22 countries); (2) high coverage, low dropout (44); (3) low coverage, severe dropout (31); and (4) low coverage, moderate dropout (40), each implying distinct priorities (conflict-adapted SIAs; sustaining gains; follow-up campaigns; expanding first-dose access).
Conclusions
Persistent and widening measles immunization gaps—especially in fragile settings—threaten IA2030's 90% coverage targets. Pairing the 2024 WUENIC revision with fragility-sensitive clustering and bounded projections provides a practical framework to prioritize equity-focused funding and operational strategies where need is greatest.
{"title":"Persistent measles immunization gaps in LMICs: Insights from the 2024 revision of the WHO/UNICEF estimates of National Immunization Coverage","authors":"Moses Mwale","doi":"10.1016/j.vaccine.2026.128298","DOIUrl":"10.1016/j.vaccine.2026.128298","url":null,"abstract":"<div><h3>Background</h3><div>Measles remains a leading vaccine-preventable killer in low- and middle-income countries (LMICs). Using the WHO/UNICEF Estimates of National Immunization Coverage (WUENIC) 2024 revisions, this article assesses measles-containing vaccine first-dose (MCV1) and second-dose (MCV2) coverage trends, inequities, and priority groups for targeted action.</div></div><div><h3>Methods</h3><div>Data from 2019 to 2024 for 137 LMICs were analysed using descriptive statistics; Welch's <em>t</em>-tests and Wilcoxon rank-sum tests to compare fragile versus non-fragile states; Gini coefficients for inequality; k-means clustering (k = 4) on coverage, MCV1-to-MCV2 dropout, change, unvaccinated counts, and fragility; and bounded linear models to project MCV1 to 2030.</div></div><div><h3>Results</h3><div>In 2024, mean MCV1 coverage was 79.2% (95% CI: 76.8–81.6)—below the 95% threshold—with fragile LMICs at 68.5% versus 87.4% in non-fragile LMICs (difference − 18.1 percentage points; <em>p</em> < 0.001). MCV2 gaps were larger (−26.9 percentage points; p < 0.001). DTP1-based zero-dose prevalence was 20.8%, with 15.6 million children unvaccinated for MCV1 and 22.4 million for MCV2; West and Central Africa accounted for 7.2 million MCV1-unvaccinated (46.2%). Inequality rose (Gini 0.22 → 0.25, 2019–2024). Projections indicate MCV1 of 84.2% by 2030, with fragile LMICs off-track. Clustering identified four profiles: (1) very low coverage, high dropout, high fragility (22 countries); (2) high coverage, low dropout (44); (3) low coverage, severe dropout (31); and (4) low coverage, moderate dropout (40), each implying distinct priorities (conflict-adapted SIAs; sustaining gains; follow-up campaigns; expanding first-dose access).</div></div><div><h3>Conclusions</h3><div>Persistent and widening measles immunization gaps—especially in fragile settings—threaten IA2030's 90% coverage targets. Pairing the 2024 WUENIC revision with fragility-sensitive clustering and bounded projections provides a practical framework to prioritize equity-focused funding and operational strategies where need is greatest.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128298"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101217","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128297
Katarzyna Pasik , Ewelina Iwan , Arkadiusz Bomba , Katarzyna Domańska - Blicharz
Salmonella vaccines constitute the largest group of antibacterial immunological veterinary medicinal products (IVMPs) introduced to the EU market by the Polish Official Medicines Control Laboratory (OMCL). This is especially relevant, as Poland is the EU's leading producer of poultry meat. The General European OMCL Network is coordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Despite strict control of IVMPs, genomic aspect has not yet been controlled in veterinary pharmacy. The aim of the project was to assess the usefulness of High-throughput sequencing (HTS) for the genetic control of vaccines. The research was conducted on the most commonly marketed serovar in Poland – Salmonella enterica subspecies enterica serovar Enteritidis (SE). Live attenuated Salmonella vaccines for chickens were tested - three batches of different vaccines (coded B-01, B-05, B-07). Several publicly available genomic tools were applied for comprehensive characterization of vaccines. Generated sequences confirmed that the main genetic component of each vaccine was S. enteritidis without significant contaminants and with stability across batches. Comparative analysis showed that B-05 and B-07 IVMPs were genetically almost identical, while B-01 was quite distant. No major antibiotic resistance genes or point mutations were detected. HTS confirmed presence of multiple virulence markers in all tested batches. Further data indicated presence of multireplicon plasmid IncF in B-05 and B-07, harbouring two virulence cassettes - pef (plasmid-encoded fimbriae) and spv (type III secretion system). The presented work is an interdisciplinary project linking quality control of IVMPs with advanced genomics. This study provides the first comprehensive genomic characterization of Salmonella enterica vaccine strains on the European market, confirming their safety, genetic stability, compliance with manufacturer declarations, and highlighting HTS as a valuable tool for vaccine quality assessment. As a supplement to phenotypic methods, HTS implementation requires coordination with manufacturers and EDQM before routine use in OMCLs.
{"title":"HTS-based control of Salmonella Enteritidis vaccines for chickens – pilot study","authors":"Katarzyna Pasik , Ewelina Iwan , Arkadiusz Bomba , Katarzyna Domańska - Blicharz","doi":"10.1016/j.vaccine.2026.128297","DOIUrl":"10.1016/j.vaccine.2026.128297","url":null,"abstract":"<div><div><em>Salmonella</em> vaccines constitute the largest group of antibacterial immunological veterinary medicinal products (IVMPs) introduced to the EU market by the Polish Official Medicines Control Laboratory (OMCL). This is especially relevant, as Poland is the EU's leading producer of poultry meat. The General European OMCL Network is coordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Despite strict control of IVMPs, genomic aspect has not yet been controlled in veterinary pharmacy. The aim of the project was to assess the usefulness of High-throughput sequencing (HTS) for the genetic control of vaccines. The research was conducted on the most commonly marketed serovar in Poland – <em>Salmonella enterica</em> subspecies <em>enterica</em> serovar Enteritidis (SE). Live attenuated <em>Salmonella</em> vaccines for chickens were tested - three batches of different vaccines (coded B-01, B-05, B-07). Several publicly available genomic tools were applied for comprehensive characterization of vaccines. Generated sequences confirmed that the main genetic component of each vaccine was <em>S. enteritidis</em> without significant contaminants and with stability across batches. Comparative analysis showed that B-05 and B-07 IVMPs were genetically almost identical, while B-01 was quite distant. No major antibiotic resistance genes or point mutations were detected. HTS confirmed presence of multiple virulence markers in all tested batches. Further data indicated presence of multireplicon plasmid IncF in B-05 and B-07, harbouring two virulence cassettes - <em>pef</em> (plasmid-encoded fimbriae) and <em>spv</em> (type III secretion system). The presented work is an interdisciplinary project linking quality control of IVMPs with advanced genomics. This study provides the first comprehensive genomic characterization of <em>Salmonella enterica</em> vaccine strains on the European market, confirming their safety, genetic stability, compliance with manufacturer declarations, and highlighting HTS as a valuable tool for vaccine quality assessment. As a supplement to phenotypic methods, HTS implementation requires coordination with manufacturers and EDQM before routine use in OMCLs.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128297"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101186","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128292
Gregory A. Poland , Tamar Ratishvili , Peter J. Pitts
{"title":"COVID-19 vaccine policy: a response and way forward","authors":"Gregory A. Poland , Tamar Ratishvili , Peter J. Pitts","doi":"10.1016/j.vaccine.2026.128292","DOIUrl":"10.1016/j.vaccine.2026.128292","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128292"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101254","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128282
In Young Park , Alejandra Cantu-Aldana , Natalie Grafft , Brian K. Lo , Katherine W. Bauer , Brent A. McBride , Sebastien J. Haneuse , Jess Haines , Kirsten K. Davison
Understanding how parents make decisions about child vaccination is important to guide interventions to increase child vaccination rates. However, few studies have examined parent vaccine decision making within households and no studies have examined this question from the perspective of fathers. In a sample of 943 fathers, from the Fathers & Families cohort and living in two-parent (father-mother) households, this study examines parents' decision making and agreement about their child receiving, or not receiving, the COVID-19 vaccine, and links with children's vaccination status. The association between fathers' and mothers' agreement about whether or not to vaccinate child against COVID-19 and child COVID-19 vaccination status was examined using multivariate logistic regression, adjusting for parent characteristics. The vast majority of fathers (89.0%) reported that they and their child's mother jointly decided on vaccinating their child and typically agreed on whether or not to vaccinate their child against COVID-19. Multivariate logistic analysis showed that children whose parents agreed on whether or not to vaccinate them were 14.8 times (B = 2.70, 95% CI: 7.1–31.2) more likely to have received the COVID-19 vaccine than those whose parents disagreed or had not discussed vaccination. The findings highlight a new avenue for outreach efforts aimed at promoting child vaccination rates through understanding fathers' specific concerns about child vaccines and communication with fathers and mothers about child vaccination.
{"title":"Fathers' reports of within-household vaccine decision making and young children's COVID-19 vaccination status","authors":"In Young Park , Alejandra Cantu-Aldana , Natalie Grafft , Brian K. Lo , Katherine W. Bauer , Brent A. McBride , Sebastien J. Haneuse , Jess Haines , Kirsten K. Davison","doi":"10.1016/j.vaccine.2026.128282","DOIUrl":"10.1016/j.vaccine.2026.128282","url":null,"abstract":"<div><div>Understanding how parents make decisions about child vaccination is important to guide interventions to increase child vaccination rates. However, few studies have examined parent vaccine decision making within households and no studies have examined this question from the perspective of fathers. In a sample of 943 fathers, from the <em>Fathers & Families</em> cohort and living in two-parent (father-mother) households, this study examines parents' decision making and agreement about their child receiving, or not receiving, the COVID-19 vaccine, and links with children's vaccination status. The association between fathers' and mothers' agreement about whether or not to vaccinate child against COVID-19 and child COVID-19 vaccination status was examined using multivariate logistic regression, adjusting for parent characteristics. The vast majority of fathers (89.0%) reported that they and their child's mother jointly decided on vaccinating their child and typically agreed on whether or not to vaccinate their child against COVID-19. Multivariate logistic analysis showed that children whose parents agreed on whether or not to vaccinate them were 14.8 times (B = 2.70, 95% CI: 7.1–31.2) more likely to have received the COVID-19 vaccine than those whose parents disagreed or had not discussed vaccination. The findings highlight a new avenue for outreach efforts aimed at promoting child vaccination rates through understanding fathers' specific concerns about child vaccines and communication with fathers and mothers about child vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128282"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101247","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128275
Timothy Kenealy , Nelson Aguirre-Duarte , Richard H. Roxburgh , Gordon Royle , Bryan Mitchelson , Joan Ingram , Nicky Williams , Helen Petousis-Harris
Background
Hospital discharge codes can be used to identify possible Adverse Events of Special Interest (AESI) following COVID-19 vaccinations.
Aim
We sought to estimate the positive predictive value (PPV) and level of certainty of ICD-10-AM and SNOMED coding for meeting Brighton Collaboration case definitions of AESIs in Aotearoa, New Zealand.
Methods
Our expert panel identified 24 ICD-10-AM codes and 2 SNOMED codes expected to identify 9 AESIs. We sought codes likely to be specific rather than sensitive. Medical record reviews were conducted by an experienced coder, adjudicated by medical specialists, for the level of certainty that each case met the target case definition. Admissions coded to an explicit alternative diagnosis were classified as Not a Case.
Results
Our data covered over 3 million people. Reviews were conducted on 761 medical records, randomly selected from admissions principally in calendar years 2016 to 2019. We report the PPV of each code with respect to its level of certainty of meeting the case definition. Only Guillain-Barré had a single code specific to a single AESI. Several neurological conditions had overlapping codes, conditions and case definitions. PPVs for individual codes to meet case definitions ranged from 11% to 100%. Level of certainty of each code and PPV are specified.
Conclusion
PPVs of codes for each AESI need to be assessed on a case-by-case basis. Many codes are arguably insufficiently ‘accurate’ to identify a target AESI. We did not assess PPVs for combinations of codes. Our method did not allow us to estimate the number of cases missed by the coding.
{"title":"Accuracy of ICD and SNOMED search strategies for adverse events following COVID-19 vaccination: Analysis of hospital administrative data","authors":"Timothy Kenealy , Nelson Aguirre-Duarte , Richard H. Roxburgh , Gordon Royle , Bryan Mitchelson , Joan Ingram , Nicky Williams , Helen Petousis-Harris","doi":"10.1016/j.vaccine.2026.128275","DOIUrl":"10.1016/j.vaccine.2026.128275","url":null,"abstract":"<div><h3>Background</h3><div>Hospital discharge codes can be used to identify possible Adverse Events of Special Interest (AESI) following COVID-19 vaccinations.</div></div><div><h3>Aim</h3><div>We sought to estimate the positive predictive value (PPV) and level of certainty of ICD-10-AM and SNOMED coding for meeting Brighton Collaboration case definitions of AESIs in Aotearoa, New Zealand.</div></div><div><h3>Methods</h3><div>Our expert panel identified 24 ICD-10-AM codes and 2 SNOMED codes expected to identify 9 AESIs. We sought codes likely to be specific rather than sensitive. Medical record reviews were conducted by an experienced coder, adjudicated by medical specialists, for the level of certainty that each case met the target case definition. Admissions coded to an explicit alternative diagnosis were classified as Not a Case.</div></div><div><h3>Results</h3><div>Our data covered over 3 million people. Reviews were conducted on 761 medical records, randomly selected from admissions principally in calendar years 2016 to 2019. We report the PPV of each code with respect to its level of certainty of meeting the case definition. Only Guillain-Barré had a single code specific to a single AESI. Several neurological conditions had overlapping codes, conditions and case definitions. PPVs for individual codes to meet case definitions ranged from 11% to 100%. Level of certainty of each code and PPV are specified.</div></div><div><h3>Conclusion</h3><div>PPVs of codes for each AESI need to be assessed on a case-by-case basis. Many codes are arguably insufficiently ‘accurate’ to identify a target AESI. We did not assess PPVs for combinations of codes. Our method did not allow us to estimate the number of cases missed by the coding.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128275"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101278","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 : 2026-01-31DOI: 10.1016/j.vaccine.2026.128289
David Cassie , Vanja Komlenovic , Geraldine Parrera , Bojan Drobic
ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] is an attenuated vaccinia vaccine indicated in the US for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. The current study assessed the ability of a screening algorithm to identify a population of previously vaccinated individuals for whom revaccination with ACAM2000 vaccine could be used to assess safety (NCT02443623). Vaccination in this study stimulated anti-vaccinia antibodies in plasma donors for the preparation of vaccinia immune globulin intravenous (VIGIV).
This was an open label, single-arm, multi-center study. The protocol criteria were designed to screen out individuals with risk factors associated with increased risk of adverse events, specifically myocarditis/pericarditis, including an algorithm to be followed in the event of symptom development. Post-vaccination safety data was collected including solicitation for symptoms of myocarditis/pericarditis.
There were 4088 participants screened, of which 3032 were vaccinated, 850 failed the screening criteria and 206 were enrolled but not vaccinated. The median age was 51, ranged from 18 to 65, and was comprised of 75% males. Out of the 3032 vaccinated participants, 1420 (47%) reported 2478 adverse events (AEs), of which 1468 AEs in 1190 (39.2%) participants were considered related. Twenty-one participants (0.7%) reported severe events, serious adverse events were uncommon (0.8%), two were considered related to vaccination and there was one unrelated death. Inadvertent autoinoculation was reported in six participants but did not require medical intervention. The most frequently reported vaccination related AEs were cutaneous reactions and constitutional symptoms. Out of 3032 vaccinated participants, 65 had potential symptoms of myocarditis/pericarditis (myopericarditis) which were resolved, and there were no diagnoses of myopericarditis.
Administration of ACAM2000 vaccine was well tolerated in this population of previously vaccinated participants.
{"title":"A phase 4, open-label, single arm, multi-center study to evaluate the safety of a smallpox vaccine in previously vaccinated individuals","authors":"David Cassie , Vanja Komlenovic , Geraldine Parrera , Bojan Drobic","doi":"10.1016/j.vaccine.2026.128289","DOIUrl":"10.1016/j.vaccine.2026.128289","url":null,"abstract":"<div><div>ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] is an attenuated vaccinia vaccine indicated in the US for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. The current study assessed the ability of a screening algorithm to identify a population of previously vaccinated individuals for whom revaccination with ACAM2000 vaccine could be used to assess safety (<span><span>NCT02443623</span><svg><path></path></svg></span>). Vaccination in this study stimulated anti-vaccinia antibodies in plasma donors for the preparation of vaccinia immune globulin intravenous (VIGIV).</div><div>This was an open label, single-arm, multi-center study. The protocol criteria were designed to screen out individuals with risk factors associated with increased risk of adverse events, specifically myocarditis/pericarditis, including an algorithm to be followed in the event of symptom development. Post-vaccination safety data was collected including solicitation for symptoms of myocarditis/pericarditis.</div><div>There were 4088 participants screened, of which 3032 were vaccinated, 850 failed the screening criteria and 206 were enrolled but not vaccinated. The median age was 51, ranged from 18 to 65, and was comprised of 75% males. Out of the 3032 vaccinated participants, 1420 (47%) reported 2478 adverse events (AEs), of which 1468 AEs in 1190 (39.2%) participants were considered related. Twenty-one participants (0.7%) reported severe events, serious adverse events were uncommon (0.8%), two were considered related to vaccination and there was one unrelated death. Inadvertent autoinoculation was reported in six participants but did not require medical intervention. The most frequently reported vaccination related AEs were cutaneous reactions and constitutional symptoms. Out of 3032 vaccinated participants, 65 had potential symptoms of myocarditis/pericarditis (myopericarditis) which were resolved, and there were no diagnoses of myopericarditis.</div><div>Administration of ACAM2000 vaccine was well tolerated in this population of previously vaccinated participants.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128289"},"PeriodicalIF":4.5,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101249","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 : 2026-01-30DOI: 10.1016/j.vaccine.2026.128256
Rachel Wittenauer , Parth D. Shah , Jennifer L. Bacci , Stephen J. Mooney , Andy Stergachis
Importance
Community pharmacists provide many important healthcare services, including routine adult vaccinations. However, an estimated 15.8 million people in the US live in pharmacy deserts and may lack access to these services. The relationship between pharmacy deserts and adult vaccine receipt has yet to be thoroughly explored empirically.
Objective
We evaluated the relationship between census tract-level pharmacy access and shingles vaccination receipt.
Design, setting, and participants
This propensity score matched analysis used 2022 vaccination data from seven collaborating State Departments of Health: Colorado, Louisiana, Massachusetts, Nevada, Oklahoma, Washington, and Wisconsin. Census tracts in those states were classified based on their access to community pharmacies in April 2022. The dataset for analysis contained 9652 census tracts representing 13.7 million adults aged 50+ years.
Exposure
Our primary exposure was whether a census tract was a “pharmacy desert”, defined as being both low-income and having low geographic access to pharmacies. Our secondary exposure was whether a tract had low geographic access to pharmacies regardless of income status of that tract.
Main outcomes
The primary outcome was completed shingles vaccinations per 1000 population age 50+ years in 2022.
Results
Pharmacy deserts had 0.4 fewer shingles vaccinations per 1000 population (p = 0.83; 95% CI -3.8, 3.6) compared to matched non-pharmacy-desert tracts. Our secondary analysis indicated that low-access tracts had 2.4 fewer vaccinations per 1000 population (p = 0.004, 95% CI: −3.9, −0.7).
Conclusions
Low pharmacy access is associated with lower rates of shingles vaccination. The definition of pharmacy desert that includes a low-income criterion may not add further precision in identifying areas with inadequate access to pharmacy-based vaccinations. Efforts at the state and national levels to prevent pharmacy closures and support pharmacists in delivering care may improve access to important pharmacy services such as vaccination.
{"title":"Pharmacy access and shingles vaccinations in the US: a propensity score matching analysis","authors":"Rachel Wittenauer , Parth D. Shah , Jennifer L. Bacci , Stephen J. Mooney , Andy Stergachis","doi":"10.1016/j.vaccine.2026.128256","DOIUrl":"10.1016/j.vaccine.2026.128256","url":null,"abstract":"<div><h3>Importance</h3><div>Community pharmacists provide many important healthcare services, including routine adult vaccinations. However, an estimated 15.8 million people in the US live in pharmacy deserts and may lack access to these services. The relationship between pharmacy deserts and adult vaccine receipt has yet to be thoroughly explored empirically.</div></div><div><h3>Objective</h3><div>We evaluated the relationship between census tract-level pharmacy access and shingles vaccination receipt.</div></div><div><h3>Design, setting, and participants</h3><div>This propensity score matched analysis used 2022 vaccination data from seven collaborating State Departments of Health: Colorado, Louisiana, Massachusetts, Nevada, Oklahoma, Washington, and Wisconsin. Census tracts in those states were classified based on their access to community pharmacies in April 2022. The dataset for analysis contained 9652 census tracts representing 13.7 million adults aged 50+ years.</div></div><div><h3>Exposure</h3><div>Our primary exposure was whether a census tract was a “pharmacy desert”, defined as being both low-income and having low geographic access to pharmacies. Our secondary exposure was whether a tract had low geographic access to pharmacies regardless of income status of that tract.</div></div><div><h3>Main outcomes</h3><div>The primary outcome was completed shingles vaccinations per 1000 population age 50+ years in 2022.</div></div><div><h3>Results</h3><div>Pharmacy deserts had 0.4 fewer shingles vaccinations per 1000 population (<em>p</em> = 0.83; 95% CI -3.8, 3.6) compared to matched non-pharmacy-desert tracts. Our secondary analysis indicated that low-access tracts had 2.4 fewer vaccinations per 1000 population (<em>p</em> = 0.004, 95% CI: −3.9, −0.7).</div></div><div><h3>Conclusions</h3><div>Low pharmacy access is associated with lower rates of shingles vaccination. The definition of pharmacy desert that includes a low-income criterion may not add further precision in identifying areas with inadequate access to pharmacy-based vaccinations. Efforts at the state and national levels to prevent pharmacy closures and support pharmacists in delivering care may improve access to important pharmacy services such as vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128256"},"PeriodicalIF":4.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079700","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 : 2026-01-30DOI: 10.1016/j.vaccine.2026.128285
Karan Thakkar , Rengina Kefalogianni , Jessie Zhang , Chee Fu Yung , Shephali Tagore , Pradip Dashraath , Amy W. Law , Diana Mendes
Background
Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections in children. A novel bivalent RSV prefusion F protein subunit (RSVpreF) vaccine has recently been approved by the Health Sciences Authority (HSA) in Singapore. This study estimated the clinical and economic impact of a year-round RSVpreF maternal vaccination program on the prevention of RSV among infants in Singapore.
Methods
A Markov cohort model was used to project clinical and economic outcomes of RSV from birth to one year of age for RSVpreF vaccine compared to no intervention. Analyses were conducted from the healthcare system perspective, with direct costs (2025 Singapore dollars [S$]) and outcomes discounted at 3% annually; scenario and sensitivity analyses tested the robustness of the model. Findings: Compared to no intervention, a year-round RSVpreF program with 80% coverage would prevent 308 hospitalizations and 1995 outpatient visits annually, averting S$2.15 million in direct medical costs and saving 29 quality-adjusted life years (QALYs). The RSVpreF vaccine would be cost-effective up to S$237.68/dose under a cost-effectiveness threshold of 1 x gross domestic product per capita (S$121,378) per QALY gained.
Interpretation
Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program.
{"title":"Clinical and economic benefits of bivalent respiratory syncytial virus prefusion F (RSVpreF) maternal vaccine for prevention of RSV illness in infants: A cost-effectiveness analysis for Singapore","authors":"Karan Thakkar , Rengina Kefalogianni , Jessie Zhang , Chee Fu Yung , Shephali Tagore , Pradip Dashraath , Amy W. Law , Diana Mendes","doi":"10.1016/j.vaccine.2026.128285","DOIUrl":"10.1016/j.vaccine.2026.128285","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections in children. A novel bivalent RSV prefusion F protein subunit (RSVpreF) vaccine has recently been approved by the Health Sciences Authority (HSA) in Singapore. This study estimated the clinical and economic impact of a year-round RSVpreF maternal vaccination program on the prevention of RSV among infants in Singapore.</div></div><div><h3>Methods</h3><div>A Markov cohort model was used to project clinical and economic outcomes of RSV from birth to one year of age for RSVpreF vaccine compared to no intervention. Analyses were conducted from the healthcare system perspective, with direct costs (2025 Singapore dollars [S$]) and outcomes discounted at 3% annually; scenario and sensitivity analyses tested the robustness of the model. Findings: Compared to no intervention, a year-round RSVpreF program with 80% coverage would prevent 308 hospitalizations and 1995 outpatient visits annually, averting S$2.15 million in direct medical costs and saving 29 quality-adjusted life years (QALYs). The RSVpreF vaccine would be cost-effective up to S$237.68/dose under a cost-effectiveness threshold of 1 x gross domestic product per capita (S$121,378) per QALY gained.</div></div><div><h3>Interpretation</h3><div>Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128285"},"PeriodicalIF":4.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079794","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 : 2026-01-29DOI: 10.1016/j.vaccine.2026.128231
Monica E. Embers , Nicole R. Hasenkampf , Amanda C. Tardo , Yekaterina Timofeyeva , Sabine Wellnitz , Yan Li , Alexey Gribenko , Jeong-Jin Park , Alexandre Esadze , Sirena Tran , Jun Sun , Jill Dane , Donna Giordano-Schmidt , Guy Singh , Michelle Gaylord , Danielle Baranova , Andreas Meinke , Urban Lundberg , Romana Hochreiter , Sandra Jost , Raphael Simon
Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, Borrelia burgdorferi sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by B. burgdorferi s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent B. burgdorferi infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six B. burgdorferi s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with Ixodes scapularis ticks bearing B. burgdorferi sensu stricto (s.s.) (OspA ST1). Levels of residual B. burgdorferi s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing in vitro and clearance of spirochetes in ticks versus those directed against other parts of the protein.
{"title":"Protective properties of a candidate C-terminal domain OspA vaccine for prevention of Lyme disease","authors":"Monica E. Embers , Nicole R. Hasenkampf , Amanda C. Tardo , Yekaterina Timofeyeva , Sabine Wellnitz , Yan Li , Alexey Gribenko , Jeong-Jin Park , Alexandre Esadze , Sirena Tran , Jun Sun , Jill Dane , Donna Giordano-Schmidt , Guy Singh , Michelle Gaylord , Danielle Baranova , Andreas Meinke , Urban Lundberg , Romana Hochreiter , Sandra Jost , Raphael Simon","doi":"10.1016/j.vaccine.2026.128231","DOIUrl":"10.1016/j.vaccine.2026.128231","url":null,"abstract":"<div><div>Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, <em>Borrelia burgdorferi</em> sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by <em>B. burgdorferi</em> s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent <em>B. burgdorferi</em> infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six <em>B. burgdorferi</em> s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with <em>Ixodes scapularis</em> ticks bearing <em>B. burgdorferi</em> sensu stricto (s.s.) (OspA ST1). Levels of residual <em>B. burgdorferi</em> s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing <em>in vitro</em> and clearance of spirochetes in ticks versus those directed against other parts of the protein.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128231"},"PeriodicalIF":4.5,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146079699","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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号