Expert Review of Vaccines最新文献_第4页

Maintaining the value of influenza vaccination - the shift from quadrivalent to trivalent vaccines: an expert review. 维持流感疫苗接种的价值——从四价疫苗向三价疫苗的转变：专家评论。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-06-08 DOI: 10.1080/14760584.2025.2515597

David Fisman, Alberto Pérez-Rubio, Maarten Postma, Darvin S Smith, Joaquin Mould-Quevedo

{"title":"Maintaining the value of influenza vaccination - the shift from quadrivalent to trivalent vaccines: an expert review.","authors":"David Fisman, Alberto Pérez-Rubio, Maarten Postma, Darvin S Smith, Joaquin Mould-Quevedo","doi":"10.1080/14760584.2025.2515597","DOIUrl":"10.1080/14760584.2025.2515597","url":null,"abstract":"Introduction: This review provides an expert perspective on the sustained value of seasonal influenza vaccines as they transition from quadrivalent to trivalent formulations, based on apparent elimination of the B/Yamagata strain from circulation and subsequent advice from the World Health Organization (WHO) to remove the B/Yamagata antigen from influenza vaccines. Influenza has a high clinical and economic burden globally. However, coronavirus disease 2019 has created new challenges for managing seasonal influenza by amplifying vaccine hesitancy. Understanding why influenza virus circulation is monitored and vaccines subsequently updated is important for all relevant stakeholders to maintain confidence in the value of seasonal influenza vaccination.Areas covered: Discussion is provided on the dynamic nature of communicable diseases, influenza virus monitoring and WHO vaccine composition guidance, and maintaining the value of influenza vaccination to individuals, society, and healthcare systems.Expert opinion: The move from quadrivalent to trivalent influenza vaccines is a result of findings from strain surveillance. Continued surveillance and targeting of vaccines against strains most commonly in circulation to keep effectiveness high, and ensure the highest value of vaccination is vital to prevent influenza infection and severe illness, thus reducing pressure on healthcare systems and reducing the economic impact of influenza outbreaks.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"499-508"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215396","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}

引用次数: 0

Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. 意外接触四价登革热减毒活疫苗 TAK-003 后的妊娠结局。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-27 DOI: 10.1080/14760584.2025.2480297

Martina Rauscher, Zeb Youard, Alice Faccin, Sanjay S Patel, Hang Pang, Olaf Zent

{"title":"Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine.","authors":"Martina Rauscher, Zeb Youard, Alice Faccin, Sanjay S Patel, Hang Pang, Olaf Zent","doi":"10.1080/14760584.2025.2480297","DOIUrl":"10.1080/14760584.2025.2480297","url":null,"abstract":"Background: The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy. Pregnant women were excluded from TAK-003 clinical studies; however, some pregnancies occurred unintentionally.Research design and methods: This post-hoc analysis of phase 2 and 3 studies, evaluated pregnancy outcomes and neonatal adverse events (AEs) following unintentional vaccination during the time period ('exposure window') when women could be pregnant (within 44 days before last menstrual period until the outcome of pregnancy).Results: Of the 557 reported pregnancies, 38 (TAK-003, n = 28/375; placebo, n = 10/182) occurred inside the exposure window. Of these, 28 (TAK-003, n = 23; placebo, n = 5) resulted in live births, four resulted in elective terminations (TAK-003, n = 2; placebo, n = 2), five in spontaneous abortions (TAK-003, n = 3; placebo, n = 2) and one unknown outcome (placebo).Of the spontaneous abortions, there was no significant difference between TAK-003 and placebo recipients, or between those occurring within or outside the exposure window. Six participants who received TAK-003 in the exposure window and two neonates experienced serious AEs; none were considered TAK-003 related.Conclusions: This post-hoc analysis found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.Clinical trial registration: The clinical trials from which data were extracted are registered at www.clinicaltrials.gov (identifiers are NCT02193087, NCT01511250, NCT02302066, NCT02425098, NCT03746015, NCT02747927, NCT03999996, NCT03423173, NCT03342898, NCT03771963, NCT04313244, NCT02948829, NCT035252119, NCT03341637).","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"221-229"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656611","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}

引用次数: 0

Estimating the potential public health and economic impact of vaccination strategies with an adapted vaccine in Colombia using a combined Markov-decision tree model. 使用马尔可夫决策树模型估计哥伦比亚适应疫苗接种战略的潜在公共卫生和经济影响。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-30 DOI: 10.1080/14760584.2025.2485251

Jair Alberto Arciniegas, Juan Manuel Reyes, Carlos Fernando Mendoza, Iustina Chirila, Moe Hein Kyaw, Omar Escobar, Jorge Enrique La Rotta, Ben Yarnoff

{"title":"Estimating the potential public health and economic impact of vaccination strategies with an adapted vaccine in Colombia using a combined Markov-decision tree model.","authors":"Jair Alberto Arciniegas, Juan Manuel Reyes, Carlos Fernando Mendoza, Iustina Chirila, Moe Hein Kyaw, Omar Escobar, Jorge Enrique La Rotta, Ben Yarnoff","doi":"10.1080/14760584.2025.2485251","DOIUrl":"10.1080/14760584.2025.2485251","url":null,"abstract":"Background: Using adapted COVID-19 vaccines targeting current variants in circulation is necessary for addressing the dynamic evolution of the SARS-CoV-2 virus and protecting against emerging variants. This study evaluated the impact of various vaccination strategies with an adapted vaccine in Colombia.Research design and methods: Using a previously published combined Markov-decision tree model adapted for the Colombia context, this study estimated the outcomes of different vaccination strategies targeting various age and risk groups. The model used age-specific epidemiology, clinical, cost, and quality of life inputs derived from the published literature and national surveillance data. Scenario and sensitivity analyses were conducted to assess uncertainty.Results: Compared to no vaccination, the vaccination strategy targeting older adults aged ≥65 years and the high-risk population was estimated to prevent 306,460 symptomatic cases, 5,200 hospitalizations, 3,381 deaths, and 39,454 lost QALYs, translating to total direct and societal cost savings of USD 70,840,305 and USD 128,918,995, respectively. These gains were further increased by expanding vaccination to additional age groups. Results were most sensitive to parameters for the attack rate and duration of protection.Conclusions: Implementing vaccination strategies targeting a broader age range with an adapted vaccine would result in considerable health and economic benefits in Colombia.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"242-251"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729651","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}

引用次数: 0

How to improve pertussis vaccination in pregnancy: a European expert review. 如何改善妊娠期百日咳疫苗接种：欧洲专家综述。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-14 DOI: 10.1080/14760584.2025.2473328

Adam Finn, Nicole Guiso, Carl Heinz Wirsing von König, Federico Martinón-Torres, Arto A Palmu, Paolo Bonanni, Pierre Bakhache, Helena C Maltezou, Pierre Van Damme

{"title":"How to improve pertussis vaccination in pregnancy: a European expert review.","authors":"Adam Finn, Nicole Guiso, Carl Heinz Wirsing von König, Federico Martinón-Torres, Arto A Palmu, Paolo Bonanni, Pierre Bakhache, Helena C Maltezou, Pierre Van Damme","doi":"10.1080/14760584.2025.2473328","DOIUrl":"10.1080/14760584.2025.2473328","url":null,"abstract":"Introduction: Pertussis vaccination in pregnancy is a safe and highly effective strategy to protect young infants against severe pertussis, but cases continue to occur. In November 2023, the authors of this paper met to discuss difficulties faced by pertussis vaccination programs in pregnant women in Europe, and the need and potential for new vaccines.Areas covered: We summarize current pertussis epidemiology, the status of pertussis vaccination in pregnancy in Europe, followed by a summary of the meeting on benefits of pertussis-only vaccines and pertussis vaccines with improved immunogenicity, including a review of available vaccines.Expert opinion: Ongoing surveillance and registers documenting vaccine uptake in pregnant women are important to monitor changes in pertussis epidemiology and estimated effectiveness of maternal pertussis vaccination programs in individual countries. While current programs have been effective, Tdap or Tdap-IPV combined vaccines are not the ideal choice but are the only vaccines available for pertussis immunization in pregnancy in Europe. Pertussis-only vaccine would avoid exposing women to unnecessary tetanus and diphtheria boosters in every pregnancy. Recombinant pertussis vaccines with higher immunogenicity could prolong passive immune protection against pertussis in young infants.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"175-182"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556241","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}

引用次数: 0

Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response. 尼帕疫苗开发和流行病防范和应对许可方面的进展和挑战。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-11 DOI: 10.1080/14760584.2025.2476523

Sol Kim, Hyolim Kang, Laura Skrip, Sushant Sahastrabuddhe, Ausraful Islam, Sung-Mok Jung, Juan F Vesga, Akira Endo, W John Edmunds, Kaja Abbas

{"title":"Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response.","authors":"Sol Kim, Hyolim Kang, Laura Skrip, Sushant Sahastrabuddhe, Ausraful Islam, Sung-Mok Jung, Juan F Vesga, Akira Endo, W John Edmunds, Kaja Abbas","doi":"10.1080/14760584.2025.2476523","DOIUrl":"10.1080/14760584.2025.2476523","url":null,"abstract":"Introduction: Nipah virus is a high-consequence pathogen that causes sporadic outbreaks with high mortality, and there are currently no vaccines or therapeutics available for Nipah. Vaccine development against Nipah faces challenges due to its current epidemiology with limited outbreak sizes, which impedes the feasibility of conducting vaccine efficacy trials focused on disease endpoints.Areas covered: We review the progress of Nipah vaccine candidates in human clinical trials and highlight the challenges in evaluating the vaccine efficacy due to the sporadic nature of Nipah outbreaks, given the epidemic potential of Nipah virus and its implications for pandemic preparedness. We examine the alternative regulatory pathways, including the US FDA's Animal Rule and EMA's conditional marketing authorization, which permit vaccine approval based on surrogate markers rather than efficacy data from the large-scale Phase-3 efficacy trials. The need for standardized immune surrogate markers is emphasized, alongside calls for international collaboration to develop such endpoints and manage stockpile strategies.Expert opinion: We recommend alignment among vaccine developers, regulators, and global health stakeholders to incentivize Nipah vaccine development and approval through alternative regulatory pathways, as well as ensuring epidemic preparedness via strategic vaccine stockpiling and response through targeted deployment strategies.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"183-193"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566539","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}

引用次数: 0

Toward elimination of hepatitis A and B in Europe: vaccination successes, challenges, and opportunities. 在欧洲实现消除甲型和乙型肝炎：疫苗接种的成功、挑战和机遇。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-05-20 DOI: 10.1080/14760584.2025.2502030

Maria Buti, Paolo Bonanni, Nimzing Ladep, George Papatheodoridis, Markus Frühwein, Cary James, John W Ward, Volker Vetter, Pasquale Cacciatore, Divya Kesters, Pavitra Dewda, Pierre Van Damme

{"title":"Toward elimination of hepatitis A and B in Europe: vaccination successes, challenges, and opportunities.","authors":"Maria Buti, Paolo Bonanni, Nimzing Ladep, George Papatheodoridis, Markus Frühwein, Cary James, John W Ward, Volker Vetter, Pasquale Cacciatore, Divya Kesters, Pavitra Dewda, Pierre Van Damme","doi":"10.1080/14760584.2025.2502030","DOIUrl":"10.1080/14760584.2025.2502030","url":null,"abstract":"Introduction: Hepatitis B and hepatitis A are vaccine-preventable infections of global concern. Hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccines available in Europe are underutilized in some age groups. While most European countries implemented childhood HBV universal routine vaccination (URV), vaccination coverage among adults remains low. Low HAV vaccination coverage among high-risk populations due to variable national vaccination policies, low awareness of vaccination benefits, and other barriers, increases the risk for outbreaks.Areas covered: We discuss the awareness of hepatitis B and hepatitis A burden in different populations in Europe, vaccination recommendations, successes, challenges, and opportunities for their implementation.Expert opinion: Awareness of at-risk populations and HBV/HAV vaccination recommendations should be raised among healthcare providers and the general population to increase access to vaccination. Increasing awareness that HBV vaccination contributes to reduction in the incidence of hepatocellular carcinoma can motivate adults to get vaccinated. Adult HBV URV may be considered in Europe, as in the United States, pending cost-effectiveness assessment at national levels. HAV vaccination recommendations should be updated and expanded to all at-risk persons. National HBV/HAV targets and vaccination strategies should be actively promoted to accelerate the elimination of viral hepatitis in Europe.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"373-383"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965363","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}

引用次数: 0

Trends in co-administration of adult vaccinations in the US retail pharmacy setting. 在美国零售药房设置成人疫苗共同管理的趋势。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-06-05 DOI: 10.1080/14760584.2025.2514517

Neha Agrawal, Alon Yehoshua, Jeffrey T Vietri, Tianyan Hu, Taryn Pond, Maria J Tort, Jingyan Yang, Verna Welch, Constantina Boikos, Sen Deng, Hao Zheng, Anchita Goswami, Manvi Sharma, Reiko Sato

{"title":"Trends in co-administration of adult vaccinations in the US retail pharmacy setting.","authors":"Neha Agrawal, Alon Yehoshua, Jeffrey T Vietri, Tianyan Hu, Taryn Pond, Maria J Tort, Jingyan Yang, Verna Welch, Constantina Boikos, Sen Deng, Hao Zheng, Anchita Goswami, Manvi Sharma, Reiko Sato","doi":"10.1080/14760584.2025.2514517","DOIUrl":"10.1080/14760584.2025.2514517","url":null,"abstract":"Background: Evidence on trends in co-administration of vaccines among adults is limited. This study assessed monthly trends in co-administration of US Advisory Committee on Immunization Practices (ACIP) recommended vaccines in the retail pharmacy setting and evaluated commonly co-administered vaccine combinations.Research design and methods: This retrospective study used Adheris Pharmacy Dataset, including adults aged ≥ 19 years who received ≥ 1 vaccine from August 2018 to December 2023. Co-administration was defined as administration of > 1 vaccine on same day. Numbers and proportions of co-administrations were assessed by month of administration and age group. Five most commonly co-administered combinations of vaccines were identified between August 2022 and December 2023.Results: Out of 161,415,432 visits with ≥ 1 vaccine administration 16,164,321 (10.0%) visits involved co-administration. Monthly co-administrations showed an upward trend from August 2018 (75,449 [11.6%]) to December 2023 (470,959 [24.0%]), with a peak in October 2023 (2,103,903 [32.6%]). Co-administration was considerably higher between September and November across the years and age groups. Influenza and COVID-19 vaccines were most commonly co-administered combination.Conclusions: Most vaccination visits (~90%) were associated with single administrations, with 10% co-administrations. An increase in vaccine co-administrations was noted in 2022 and 2023 for all age groups compared to those between 2018-2021.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"470-478"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198568","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}

引用次数: 0

Control measures for neglected tropical diseases: vaccine updates. 被忽视的热带病控制措施：疫苗更新。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-06-14 DOI: 10.1080/14760584.2025.2517712

Vivek P Chavda, Suneetha Vuppu, Toshika Mishra, Nikita Sharma, Sathvika Kamaraj, Shatakshi Mishra, Bhumi Sureshbhai, John Matsoukas, Vasso Apostolopoulos

{"title":"Control measures for neglected tropical diseases: vaccine updates.","authors":"Vivek P Chavda, Suneetha Vuppu, Toshika Mishra, Nikita Sharma, Sathvika Kamaraj, Shatakshi Mishra, Bhumi Sureshbhai, John Matsoukas, Vasso Apostolopoulos","doi":"10.1080/14760584.2025.2517712","DOIUrl":"10.1080/14760584.2025.2517712","url":null,"abstract":"Introduction: Infectious diseases like neglected tropical diseases (NTDs) have seen a rapid surge in recent times, threatening public health. These diseases impose a significant global health burden, affecting individuals, particularly in tropical locations characterized by low-income populations. The comprehensive compilation of NTDs includes an array of bacterial, viral, and parasitic infections. The prioritization of 20-NTD action plans in 2020 was undertaken by the WHO to acknowledge their importance. Infections such as leishmaniasis, schistosomiasis, and human African trypanosomiasis exhibit high rates of mortality. This highlights the pressing need for collaborative initiatives aimed at addressing these diseases and minimizing their detrimental impact on susceptible populations.Areas covered: The etiology, types of NTDs, and management strategies, particularly vaccinations are discussed. The limitations of the available vaccines and the scope of development of novel formulations are also covered.Expert opinion: The emergence of vaccines for NTDs poses significant challenges, mostly arising from the complex developmental phases of diverse diseases, inadequate resources for research, minimal involvement from the pharmaceutical industry, and the wide spectrum of infections, impeding vaccine development. Advancements in technology have improved vaccine quality, which could lead to the development of personalized vaccines tailored to individual susceptibility to specific NTD pathogens.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"535-555"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247250","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}

引用次数: 0

Cost-effectiveness of bivalent respiratory syncytial virus prefusion F vaccine for prevention of respiratory syncytial virus among older adults in Germany. 德国老年人接种二价呼吸道合胞病毒预混 F 疫苗预防呼吸道合胞病毒的成本效益。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2024-12-18 DOI: 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":"Introduction: 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.Research design and methods: 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.Results: Among adults aged 60-99 years (N = 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.Conclusions: RSVpreF has the potential to greatly reduce the public health and economic burden of RSV among older adults in Germany.","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}

引用次数: 0

Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine. mRNA疫苗中dsRNA杂质的免疫机制及控制策略研究进展。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-06-02 DOI: 10.1080/14760584.2025.2510335

Xinjun Liu, Chaoying Hu, Qian He, Yu Bai, Xuanxuan Zhang, Zhihao Fu, Xiao Ma, Miao Xu, Zhenglun Liang, Qunying Mao

{"title":"Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine.","authors":"Xinjun Liu, Chaoying Hu, Qian He, Yu Bai, Xuanxuan Zhang, Zhihao Fu, Xiao Ma, Miao Xu, Zhenglun Liang, Qunying Mao","doi":"10.1080/14760584.2025.2510335","DOIUrl":"10.1080/14760584.2025.2510335","url":null,"abstract":"Introduction: Double-stranded RNA (dsRNA) is a key impurity of mRNA vaccines prepared by in vitro transcription (IVT) and is primarily transcribed by T7 RNA polymerase. It can trigger innate immunity and induce a series of side effects that may influence the safety of mRNA vaccines.Areas covered: This manuscript summarizes dsRNA generation mechanisms and immunity activation and analyzes the current challenges in dsRNA detection and control strategies. Regulatory standards for dsRNA impurities in mRNA vaccines have also been discussed.Expert opinion: dsRNA as a critical quality attribute (CQA), the structural heterogeneity of it (including length and structure) and its precise immunomodulatory mechanisms affecting vaccine safety are poorly understood. Regulatory authorities have not released specific standards for dsRNA. Additionally, there is a lack of comparative analysis data on different corporate testing methods. Therefore, to ensure the safety of dsRNA containing mRNA vaccines and improve mRNA-based platforms, it is of great significance to establish standardized detection methods and standards for dsRNA; to design mRNA production with low dsRNA impurities by adopting the quality by design (QbD) approach; and to evaluate the immune stimulation mechanism of dsRNA impurities in mRNA vaccines.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"457-469"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119203","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}

引用次数: 0