Expert Review of VaccinesPub Date : 2025-12-01Epub Date: 2024-12-18DOI: 10.1080/14760584.2024.2436183
Ahuva Averin, Bennet Huebbe, Mark Atwood, Lea J Bayer, Caroline Lade, Christof von Eiff, Reiko Sato
{"title":"Cost-effectiveness of bivalent respiratory syncytial virus prefusion F vaccine for prevention of respiratory syncytial virus among older adults in Germany.","authors":"Ahuva Averin, Bennet Huebbe, Mark Atwood, Lea J Bayer, Caroline Lade, Christof von Eiff, Reiko Sato","doi":"10.1080/14760584.2024.2436183","DOIUrl":"https://doi.org/10.1080/14760584.2024.2436183","url":null,"abstract":"<p><strong>Introduction: </strong>Among older adults, lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) is common. We evaluated the cost-effectiveness of bivalent RSV prefusion F protein-based vaccine (RSVpreF) for prevention of RSV-LRTI among older adults in Germany.</p><p><strong>Research design and methods: </strong>A static cohort model was developed to estimate lifetime health and economic outcomes of RSV-LRTI among adults aged 60-99 years in Germany, with (vs. without) use of RSVpreF. Vaccine uptake ranged from 27% to 54%. Vaccine effectiveness was derived from trial data and was assumed to last over 3 years, with some waning, following vaccination. Base case analyses were conducted from the societal perspective (costs/benefits discounted 3% annually); sensitivity analyses also were conducted.</p><p><strong>Results: </strong>Among adults aged 60-99 years (<i>N</i> = 25.3 M), RSVpreF prevented 117,360 cases of hospitalized RSV-LRTI, 100,433 cases of ambulatory RSV-LRTI, and 9,298 RSV-LRTI-related deaths over a lifetime horizon. With total overall costs higher by 1.8 € billion and 49,576 quality-adjusted life-years (QALYs) gained, cost-effectiveness of RSVpreF was 36,064 €/QALY. In probabilistic sensitivity analyses, the mean cost-effectiveness ratio was 36,518 €/QALY; 925 of 1,000 replications yielded ratios <50,000 €/QALY.</p><p><strong>Conclusions: </strong>RSVpreF has the potential to greatly reduce the public health and economic burden of RSV among older adults in Germany.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"24 1","pages":"1-10"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846217","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}
Expert Review of VaccinesPub Date : 2025-12-01Epub Date: 2025-01-27DOI: 10.1080/14760584.2025.2458179
Alane Izu, Eleanora Aml Mutsaerts, Courtney Olwagen, Lisa Jose, Anthonet Koen, Amit J Nana, Clare L Cutland, Shabir A Madhi
{"title":"Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study.","authors":"Alane Izu, Eleanora Aml Mutsaerts, Courtney Olwagen, Lisa Jose, Anthonet Koen, Amit J Nana, Clare L Cutland, Shabir A Madhi","doi":"10.1080/14760584.2025.2458179","DOIUrl":"https://doi.org/10.1080/14760584.2025.2458179","url":null,"abstract":"<p><strong>Background: </strong>Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valent (PCV10) and 13-valent (PCV13) vaccines.</p><p><strong>Research design and methods: </strong>A single-center, open-label, randomized trial conducted in Soweto, South Africa, evaluated the immunogenicity of differing dosing schedule for PCV10 and PCV13. Six hundred children were randomly assigned to six study arms (1:1:1:1:1:1). Non-inferiority was concluded when the lower limit of the 96% confidence interval of the ratio of geometric mean concentrations (GMCs) of the 1 + 1 and 2 + 1 schedules was >0.5 for at least 10 and eight of the PCV13 and PCV10 serotypes, respectively.</p><p><strong>Results: </strong>GMCs in children who received the PCV13_6w + 1 and PCV13_14w + 1 schedule were non-inferior for 11 and 10 of the PCV13 serotypes, respectively, compared with the PCV13_2 + 1 arm. For PCV10, GMCs for both 1 + 1 schedules were non-inferior to a 2 + 1 schedule for nine of the PCV10 serotypes.</p><p><strong>Conclusion: </strong>Transitioning to a 1 + 1 schedule should be considered for early immunization programs.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov identifier is NCT02943902.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"24 1","pages":"121-127"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046157","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}
{"title":"Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged ≥18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial.","authors":"Bei-Fang Yang, Jing Jin, Xi-Ran He, Zhong-Hua Yang, Xiao'ai Qian, Ye-Qing Tong, Chang-Xian Ke, Zhao-Hong Li, Zhao-Xia Li, Lin-Feng Zhong, Ze-Hong Gan, Xian-Feng Zhang, Ying Zeng","doi":"10.1080/14760584.2024.2446288","DOIUrl":"10.1080/14760584.2024.2446288","url":null,"abstract":"<p><strong>Background: </strong>LYB001 is a recombinant protein COVID-19 vaccine displaying a receptor-binding domain (RBD) in a highly immunogenic array on virus-like particles (VLPs). This study assessed the immunogenicity and safety of LYB001 as a booster.</p><p><strong>Research design and methods: </strong>In this randomized, active-controlled, double-blinded, phase 3 trial, participants aged ≥ 18 years received a booster with LYB001 or ZF2001 (Recombinant COVID-19 Vaccine). The primary endpoint was to compare the geometric mean titer (GMT) of neutralizing antibodies against Omicron BA.4/5 at 14 days after the booster.</p><p><strong>Results: </strong>Overall, 1,200 participants aged ≥ 18 years were enrolled, 599 received LYB001, and 601 received ZF2001. Based on similar baseline level, the 14-day GMT ratio (LYB001/ZF2001) against Omicron BA.4/5 was 1.39 (95% CI: 1.25, 1.56), demonstrating superiority (95% CI lower limit > 1) of LYB001. The spike protein-binding IgG concentrations induced by LYB001 were significantly higher than those induced by ZF2001 on day 14 and day 28 after the booster (<i>p</i>-value <0.0001). LYB001 recipients reported more adverse reactions than ZF2001 recipients (21.4% vs. 15.0%); however, all adverse reactions in the LYB001 group were mild-to-moderate.</p><p><strong>Conclusions: </strong>LYB001 is highly immunogenic and retains a well-characterized safety profile in adults aged ≥ 18 years.</p><p><strong>Clinical trial registration: </strong>www.clinicaltrials.gov, identifier is NCT05664932.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"81-90"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885396","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}
Expert Review of VaccinesPub Date : 2025-12-01Epub Date: 2025-02-03DOI: 10.1080/14760584.2025.2459751
Richard Voellmy, David C Bloom, Nuria Vilaboa
{"title":"Regulated microbe vaccines: from concept to (pre-clinical) reduction to practice.","authors":"Richard Voellmy, David C Bloom, Nuria Vilaboa","doi":"10.1080/14760584.2025.2459751","DOIUrl":"10.1080/14760584.2025.2459751","url":null,"abstract":"<p><strong>Introduction: </strong>Vaccines to prevent important infections involving, e.g. influenza viruses, severe acute respiratory syndrome-causing coronaviruses (e.g. SARS-CoV-2), respiratory syncytial viruses (RSV), and human immunodeficiency viruses (HIV) have remained insufficiently effective or are not available at all. Regulated microbes constitute novel vaccine platforms that may be employed for the development of more potent and/or more broadly effective vaccines.</p><p><strong>Areas covered: </strong>We review the development and characterization of the vaccine potential of replication-competent controlled herpesviruses (RCCVs) which represent the first examples of regulated microbes used as vaccines.</p><p><strong>Expert opinion: </strong>The RCCVs developed to date are suitable for application to the skin and can be activated deliberately to replicate efficiently, but only transiently, in the administration site. Without activation, the RCCVs are incapable of replicating in the nervous system and elsewhere. The RCCVs were found to induce potent anti-herpetic immune responses in mice. Vaccination with RCCVs expressing an influenza virus hemagglutinin broadly protected animals against lethal influenza virus challenges. This protection appeared to be at least in part antibody-mediated. These findings support a rational expectation that RCCVs may be developed into universal, non-seasonal vaccines against influenza and, possibly, against other rapidly evolving pathogens.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"146-156"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052110","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}
{"title":"Estimating the time required to reach HPV vaccination targets across Europe.","authors":"Ilias Gountas,Mohammed Aman,Deepak Alexander,Robert Hughes,Georgie Weston,Ugne Sabale","doi":"10.1080/14760584.2024.2402535","DOIUrl":"https://doi.org/10.1080/14760584.2024.2402535","url":null,"abstract":"BACKGROUNDCervical cancer (CC) is one of the most common causes of cancer-related deaths in women. The World Health Organization (WHO) has called for the CC elimination as a public health priority and has urged countries to achieve a 90% vaccine coverage rate of human papilloma virus (HPV) vaccination among 15-year-old girls by 2030.RESEARCH DESIGN AND METHODSRegression models were fitted to the WHO HPV vaccine coverage rate data to estimate when the 90% vaccine coverage rate target would be achieved in 22 European countries.RESULTSThe mean vaccine coverage rate of included countries was 62.2% (SD: 18.3). Nine countries (Iceland, Norway, Portugal, Ireland, Hungary, Spain, Sweden, Denmark, and Switzerland) are expected to achieve a 90% vaccine coverage rate by 2030. Six countries (Estonia, Cyprus, Netherlands, France, Germany, and Italy) are expected to reach a 90% vaccine coverage rate between 2030 and 2040 whereas seven countries (Belgium, Bulgaria, Finland, Latvia, Luxembourg, Malta, and Slovenia) are not expected to achieve the 90% vaccine coverage rate target by 2040.CONCLUSIONThe majority of European countries are not on track to achieve 90% vaccine coverage rate by 2030. To achieve this, a significant increase in the annual vaccine coverage rate growth rate is required.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"21 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142268865","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}
Mary Bausch-Jurken,Rachel S Dawson,Francesca Ceddia,Veronica Urdaneta,Morgan A Marks,Yohei Doi
{"title":"A descriptive review on the real-world impact of Moderna, inc. COVID-19 vaccines.","authors":"Mary Bausch-Jurken,Rachel S Dawson,Francesca Ceddia,Veronica Urdaneta,Morgan A Marks,Yohei Doi","doi":"10.1080/14760584.2024.2402955","DOIUrl":"https://doi.org/10.1080/14760584.2024.2402955","url":null,"abstract":"INTRODUCTIONSince the original COVID-19 vaccines were developed, abundant clinical trial and real-world evidence evaluating the efficacy, effectiveness, and safety of COVID-19 vaccines has been collected. Knowledge of the relative benefits and risks of COVID-19 vaccines is essential for building trust within target populations, ensuring they remain effectively and safely protected against an enduring infectious threat.AREAS COVEREDThis descriptive review discusses the benefits and risks associated with marketed Moderna, Inc. mRNA-based COVID-19 vaccines, focusing on their real-world effectiveness and safety profiles in various age groups. Adverse events of interest and potential benefits of vaccination are reviewed, including reduced risk for severe COVID-19 and long-term health outcomes, reduced economic and societal costs, and reduced risk for SARS-CoV-2 transmission.EXPERT OPINIONPost-marketing safety and real-world data for Moderna, Inc. COVID-19 mRNA vaccines strongly support a positive benefit - risk profile favoring vaccination across all age groups. Although COVID-19 is no longer considered a global health pandemic, health risks associated with SARS-CoV-2 infection remain high. Concerted efforts are required to engage communities and maintain protection through vaccination. Continued surveillance of emerging variants and monitoring of vaccine safety and effectiveness are crucial for ensuring sustained protection against SARS-CoV-2.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"81 5 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142268864","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}
Mario Rivera-Izquierdo,Arturo Morales-Portillo,Inmaculada Guerrero-Fernández de Alba,Nicolás Francisco Fernández-Martínez,Joan Antoni Schoenenberger-Arnaiz,José Luis Barranco-Quintana,Carmen Valero-Ubierna
{"title":"Vaccination strategies for patients under monoclonal antibody and other biological treatments: an updated comprehensive review based on EMA authorizations to January 2024.","authors":"Mario Rivera-Izquierdo,Arturo Morales-Portillo,Inmaculada Guerrero-Fernández de Alba,Nicolás Francisco Fernández-Martínez,Joan Antoni Schoenenberger-Arnaiz,José Luis Barranco-Quintana,Carmen Valero-Ubierna","doi":"10.1080/14760584.2024.2401839","DOIUrl":"https://doi.org/10.1080/14760584.2024.2401839","url":null,"abstract":"INTRODUCTIONMonoclonal antibodies (mAbs) and other biological agents are being increasingly approved in the last years with very different indications. Their highly heterogeneous immunosuppressive effects, mechanisms of action and pharmacokinetics require comprehensive individualized vaccination schedules.AREAS COVEREDVaccination for immunocompromised patients. Prevention and treatment with mAbs and other biological therapies.EXPERT OPINIONCurrent recommendations on vaccine schedules for patients under mAbs or other biological treatments are based on expert opinions and are not individualized according to each vaccine and treatment. No studies are focusing on the high heterogeneity of these agents, that are exponentially developed and used for many different indications. Recent paradigm changes in vaccine development (boosted by the COVID-19 pandemic) and in the mAbs use for prophylactic purposes (changing 'vaccination' by 'immunization' schedules) has been witnessed in the last years. We aimed at collecting all mAbs used for treatment or prevention, approved as of 1 January 2024, by the EMA. Based on available data on mAbs and vaccines, we propose a comprehensive guide for personalizing vaccination. Recent vaccine developments and current population strategies (e.g. zoster vaccination or prophylactic nirsevimab) are discussed. This review aims to be a practical guideline for professionals working in vaccine consultations for immunosuppressed patients.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"45 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142195989","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}
{"title":"Anti-neuraminidase immunity in the combat against influenza","authors":"Xiaojian Zhang, Ted M. Ross","doi":"10.1080/14760584.2024.2343689","DOIUrl":"https://doi.org/10.1080/14760584.2024.2343689","url":null,"abstract":"Anti-neuraminidase (NA) immunity correlates with the protection against influenza virus infection in both human and animal models. The aim of this review is to better understand the mechanism of an...","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"34 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140613032","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}
Shanti Pather, Alexander Muik, Ruben Rizzi, Federico Mensa
{"title":"Developing variant-adapted COVID-19 vaccines to improve protection against Omicron and other recent variants: a plain language summary","authors":"Shanti Pather, Alexander Muik, Ruben Rizzi, Federico Mensa","doi":"10.1080/14760584.2024.2320858","DOIUrl":"https://doi.org/10.1080/14760584.2024.2320858","url":null,"abstract":"What are variant-adapted COVID-19 vaccines?The COVID-19 vaccine developed by BioNTech and Pfizer is known as BNT162b2 (Comirnaty). BNT162b2 contains messenger RNA, or mRNA, from SARS-CoV-2. SARS-Co...","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"118 1","pages":""},"PeriodicalIF":6.2,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140565870","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-01-04DOI: 10.1080/14760584.2023.2299401
Dominika A Kalkowska, Kamran Badizadegan, Janell A Routh, Cara C Burns, Eli S Rosenberg, I Ravi Brenner, Jane R Zucker, Marisa Langdon-Embry, Kimberly M Thompson
{"title":"Modeling undetected poliovirus circulation following the 2022 outbreak in the United States.","authors":"Dominika A Kalkowska, Kamran Badizadegan, Janell A Routh, Cara C Burns, Eli S Rosenberg, I Ravi Brenner, Jane R Zucker, Marisa Langdon-Embry, Kimberly M Thompson","doi":"10.1080/14760584.2023.2299401","DOIUrl":"10.1080/14760584.2023.2299401","url":null,"abstract":"<p><strong>Background: </strong>New York State (NYS) reported a polio case (June 2022) and outbreak of imported type 2 circulating vaccine-derived poliovirus (cVDPV2) (last positive wastewater detection in February 2023), for which uncertainty remains about potential ongoing undetected transmission.</p><p><strong>Research design and methods: </strong>Extending a prior deterministic model, we apply an established stochastic modeling approach to characterize the confidence about no circulation (CNC) of cVDPV2 as a function of time since the last detected signal of transmission (i.e. poliovirus positive acute flaccid myelitis case or wastewater sample).</p><p><strong>Results: </strong>With the surveillance coverage for the NYS population majority and its focus on outbreak counties, modeling suggests a high CNC (95%) within 3-10 months of the last positive surveillance signal, depending on surveillance sensitivity and population mixing patterns. Uncertainty about surveillance sensitivity implies longer durations required to achieve higher CNC.</p><p><strong>Conclusions: </strong>In populations that maintain high overall immunization coverage with inactivated poliovirus vaccine (IPV), rare polio cases may occur in un(der)-vaccinated individuals. Modeling demonstrates the unlikeliness of type 2 outbreaks reestablishing endemic transmission or resulting in large absolute numbers of paralytic cases. Achieving and maintaining high immunization coverage with IPV remains the most effective measure to prevent outbreaks and shorten the duration of imported poliovirus transmission.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"186-195"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11284832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139073821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}