Vaccine: X最新文献

{"title":"A cost benefit analysis of varicella vaccination in South Korea","authors":"Young Hwa Lee ,&nbsp;Young June Choe","doi":"10.1016/j.jvacx.2024.100521","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100521","url":null,"abstract":"<div><h3>Background</h3><p>The introduction of varicella vaccination has significantly reduced the burden of chickenpox in many countries, but outbreaks still occur in populations with high vaccination coverage. To address this, some countries, including the United States, Germany, and Japan, have adopted a two-dose varicella vaccination recommendation. Economic evaluations are crucial for assessing vaccine recommendations; however, there are limited studies exist in Asian countries. Thus, our study aimed to evaluate the cost-benefit of one-dose and two-dose varicella vaccination programs compared to no vaccination in South Korea, incorporating updated data on disease burden and costs.</p></div><div><h3>Methods</h3><p>We utilized data from South Korea’s health databases to estimate varicella burden and vaccination records. Decision tree analysis was employed to compare costs and benefits of vaccination strategies over a ten-year period for the 2012 birth cohort. Sensitivity analyses were conducted to assess the impact of various variables.</p></div><div><h3>Results</h3><p>Both one-dose and two-dose vaccination programs showed cost-benefit compared to no vaccination, with substantial societal cost savings. The one-dose program yielded a benefit-cost ratio (BCR) of1.43, while the two-dose program had a direct BCR of1.28. Sensitivity analyses confirmed the robustness of these findings.</p></div><div><h3>Conclusion</h3><p>Our study demonstrates the economic benefits of varicella vaccination in South Korea, aligning with findings from other countries. While the second dose did not show additional cost savings compared to the one-dose program, other factors like disease severity and transmission dynamics should be considered. Implementing either a one-dose or two-dose varicella vaccination regimen in South Korea could lead to cost reductions and improved cost-effectiveness compared to no vaccination, emphasizing the importance of vaccination programs in reducing disease burden and enhancing public health outcomes.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100521"},"PeriodicalIF":2.7,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000949/pdfft?md5=bdbfec9afed612e1515cd7f202994bb9&pid=1-s2.0-S2590136224000949-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141582448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategies used to improve vaccine uptake among healthcare providers: A systematic review","authors":"Rosaline de Koning ,&nbsp;Mariana Gonzalez Utrilla ,&nbsp;Emma Spanaus ,&nbsp;Michael Moore ,&nbsp;Marta Lomazzi","doi":"10.1016/j.jvacx.2024.100519","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100519","url":null,"abstract":"<div><h3>Background</h3><p>Vaccination is one of the most effective available public health tools, preventing infectious diseases to safeguard public health and save millions of lives annually. However, in recent years vaccine hesitancy has increased among all populations, including healthcare workers. Healthcare providers are central to vaccination efforts due to their increased exposure to disease and vulnerable patients, and their role in patient confidence and decision-making. These decreasing uptake rates highlight a critical need to address specific barriers within this target group. This systematic review aims to explore the strategies used to improve vaccine uptake among healthcare providers.</p></div><div><h3>Methods</h3><p>A literature search was conducted in PubMed, EMBASE, and MEDLINE databases, alongside a grey literature search, to identify studies describing interventions to improve vaccine uptake among healthcare providers. This was followed by de-duplication and double-blinded screening processes using Rayyan. Data extraction and thematic analysis focused on categorising interventions and identifying frequencies of use, to develop recommendations for further interventions tailored to target regions.</p></div><div><h3>Results</h3><p>60 studies were identified, predominantly concerning influenza vaccination. Interventions included educational initiatives, reminders, incentives, access solutions, feedback, and policy implementation. Key strategies included targeted educational lectures, posters, and pamphlets; mobile vaccination units; extended vaccination hours; and leadership engagement. The findings underscore the importance of a multifaceted approach combining educational efforts, enhanced accessibility, and motivational incentives to improve vaccination rates within the healthcare providers, especially where mandatory vaccination is controversial.</p></div><div><h3>Conclusions</h3><p>This review evaluates tailored strategies to enhance vaccine confidence and uptake among healthcare providers, advocating for a holistic approach that includes educational initiatives, reminder systems, incentives, improved access, feedback mechanisms, and policy enactment to effectively address hesitancy and promote public health.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100519"},"PeriodicalIF":2.7,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000925/pdfft?md5=3a251650cc1275f8cf85a7c719333c15&pid=1-s2.0-S2590136224000925-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141605486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influenza virus circulation and vaccine effectiveness during June 2021–May 2023 in Thailand","authors":"Kriengkrai Prasert ,&nbsp;Prabda Praphasiri ,&nbsp;Sutthichai Nakphook ,&nbsp;Darunee Ditsungnoen ,&nbsp;Patranuch Sapchookul ,&nbsp;Kanlaya Sornwong ,&nbsp;Suriya Naosri ,&nbsp;Pilailuk Akkapaiboon Okada ,&nbsp;Piyarat Suntarattiwong ,&nbsp;Tawee Chotpitayasunondh ,&nbsp;Martha P. Montgomery ,&nbsp;William W. Davis ,&nbsp;Chakrarat Pittayawonganon","doi":"10.1016/j.jvacx.2024.100517","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100517","url":null,"abstract":"<div><p>Thai Ministry of Public Health recommends influenza vaccination for certain risk groups. We evaluated 2023 Southern Hemisphere influenza vaccine effectiveness against medically attended influenza using surveillance data from nine Thai hospitals and a test-negative design. During June 2022–May 2023, influenza vaccine provided moderate protection against seeking care for influenza illness (adjusted vaccine effectiveness 51%; 95% confidence interval 28–67). Understanding vaccine effectiveness can help guide future antigen selection and support clinicians to make a strong influenza vaccine recommendation to patients.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100517"},"PeriodicalIF":2.7,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000901/pdfft?md5=aca4657bd688ff08ea95db57f2b59638&pid=1-s2.0-S2590136224000901-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141479815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and duration of additional immune defense provided by SARS-CoV-2 infection before and after receiving the mRNA COVID-19 vaccine BNT162b2","authors":"Nagashige Shimada ,&nbsp;Satoshi Sugawa ,&nbsp;Satoshi Murakami ,&nbsp;Masahiro Shinoda ,&nbsp;Shinichiro Ota ,&nbsp;Miwa Morikawa ,&nbsp;Hiroaki Takei ,&nbsp;Yusuke Serizawa ,&nbsp;Hidenori Takahashi ,&nbsp;Mio Toyama-Kousaka ,&nbsp;Hiroto Matsuse ,&nbsp;Masaharu Shinkai","doi":"10.1016/j.jvacx.2024.100518","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100518","url":null,"abstract":"<div><h3>Background</h3><p>Our investigation focused whether infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) before or after receiving the mRNA COVID-19 vaccine can increase immune protection. And we also investigated relationship of infection acquired.</p></div><div><h3>Methods</h3><p>Three shots of the mRNA coronavirus disease 2019 (COVID-19) vaccine BNT162b2 were administered to 736 healthcare workers at Tokyo Shinagawa Hospital. Serum samples were collected before the first shot (P1), at one month (P2), and at six months (P3) after the second shot and at one month after the third shot (P4). The presence of infection was assessed using IgG against the nucleocapsid (IgG (N) and RBD in the spike protein of SARS-CoV-2. We defined infection before P2 as natural infection (NI) and infection between P2 and P3 as breakthrough infection (BI) and compared susceptibility to further infection between the NI (−) and NI (+) groups and between BI (−) and BI (+) groups. Events in 485 participants who had a complete dataset of IgG (N) and IgG (RBD) from P1 to P4 were analyzed.</p></div><div><h3>Results</h3><p>The presence of SARS-CoV-2 infection before P2 were examined by examining the titers of IgG (N)P1, IgG (N) P2, and IgG (RBD) P1 that exceeded the cutoff values. Consequently, 35 participants (7.22 %) were categorized into the NI (+) group, whereas 450 (92.8 %) were categorized into the NI (−) group. Between P2 and P3, the NI (−) group showed a higher rate of SARS-CoV-2 infection than the NI (+) group; however, there was no significant difference in the infection rate between P3 and P4. The infection rate was significantly lower in the BI (+) group than in the BI (−) group. Pre-primary vaccination infection significantly increased IgG (RBD) levels between P1 and P3. Post-primary vaccination infection significantly increased IgG (RBD) levels between P3 and P4.</p></div><div><h3>Conclusions</h3><p>Infection with SARS-CoV-2 before or after receiving the mRNA COVID-19 vaccine can increase immune protection; however, the duration of this effect may be limited.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100518"},"PeriodicalIF":2.7,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000913/pdfft?md5=8d31f708130709812a520e8a63de9259&pid=1-s2.0-S2590136224000913-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring COVID-19 vaccine hesitancy among young adults in Australia. A qualitative study","authors":"Zachary Sum,&nbsp;Ernesta Sofija,&nbsp;Bernadette Sebar","doi":"10.1016/j.jvacx.2024.100515","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100515","url":null,"abstract":"<div><h3>Background</h3><p>COVID-19 vaccine hesitancy among young adults in Australia is still poorly understood. Young adults aged 25–34 years have been identified as a population subgroup where COVID-19 vaccine-hesitant views are highly prevalent.</p></div><div><h3>Objective</h3><p>Exploring the attitudes, thoughts, feelings and social environments affecting the decision to have or not have the vaccine can provide vital transferrable lessons in future health campaigns.</p></div><div><h3>Methods</h3><p>A qualitative phenomenological study was conducted using semi-structured phone interviews between June 2021 and July 2021. Interview questions were adopted from the World Health Organization’s guidance document ‘Data for Action: Achieving High Uptake of COVID-19 Vaccines’. Participants aged 25–34 years (n = 26) were recruited via purposive and snowball sampling methods. Data were analysed thematically.</p></div><div><h3>Results</h3><p>Overall, participants presented themselves as highly vaccine literate, understanding their social contract with society. Many participants also did not display traditional vaccine-hesitant views. Six themes specifically regarding COVID-19 vaccine hesitancy were identified, namely (1) decision-making complexities, (2) perceived risk of COVID-19 infection, (3) media’s misrepresentation of COVID-19, (4) vaccine-related issues, (5) inconsistent government messaging and program execution, and (6) social benefits assessment. In addition, motivators to COVID-19 vaccine uptake were classified into three categories: (1) tangible benefits, (2) protecting others, and (3) mandates and incentives. Findings suggest the motivators for COVID-19 vaccine uptake in young adults depend on individual benefits, highlighting the importance of recognising and addressing personal concerns.</p></div><div><h3>Conclusion</h3><p>There is a need to re-examine and redefine the meaning of vaccine hesitancy in young Australian adults. We offer an understanding of prospective challenges with vaccine hesitancy and potential solutions to address them. These include carefully tailored approaches regarding ongoing vaccine safety concerns and the expected personal benefits following vaccination. Combining these factors can aid in developing new methods of public engagement in the next public health crisis.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100515"},"PeriodicalIF":2.7,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000883/pdfft?md5=6255dad6ce84644cf920670ab0af6ad5&pid=1-s2.0-S2590136224000883-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lipodystrophy following Covid-19 Vaccination: A case report","authors":"Mehrnaz Shakarami ,&nbsp;Farnaz Sinaei ,&nbsp;Bardiya Ghaderi Yazdi ,&nbsp;Bentolhoda Ziaadini","doi":"10.1016/j.jvacx.2024.100513","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100513","url":null,"abstract":"<div><p>Lipodystrophy is a medical condition characterized by complete or partial loss of adipose tissue. The etiology of lipoatrophy can be congenital or acquired, including traumatic, iatrogenic, or idiopathic. Rarely, vaccination can cause lipodystrophy. Here, we report the first case of lipodystrophy associated with the COVID-19 Sinopharm vaccine in a 55-year-old woman.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100513"},"PeriodicalIF":2.7,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S259013622400086X/pdfft?md5=10131a627df61e2862af12f54fd981e3&pid=1-s2.0-S259013622400086X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141582459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse events of COVID-19 vaccination during 2021–2022 suppressed by breakfast consumption and favorable sleeping habit among Japanese university students","authors":"Nobuyuki Tetsuka ,&nbsp;Keiko Suzuki ,&nbsp;Kodai Suzuki ,&nbsp;Takuma Ishihara ,&nbsp;Takao Miwa ,&nbsp;Satoko Tajirika ,&nbsp;Miho Adachi ,&nbsp;Ryo Horita ,&nbsp;Taku Fukao ,&nbsp;Mayumi Yamamoto","doi":"10.1016/j.jvacx.2024.100516","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100516","url":null,"abstract":"<div><h3>Introduction</h3><p>Young adults are hesitant to receive the coronavirus disease 2019 (COVID-19) vaccination owing to concerns regarding adverse events despite the effectiveness of vaccines in preventing SARS-CoV-2 infection-associated serious illness, hospitalization, and death.</p></div><div><h3>Methods</h3><p>A retrospective cohort study was conducted in Gifu University students receiving the mRNA-1273 vaccine and boosters to elucidate the real incidence of adverse events and factors that prevent them. We examined the adverse events and identified potential risk factors through a self-administered questionnaire on the participants’ physical condition after COVID-19 vaccination.</p></div><div><h3>Results</h3><p>Focal/systemic adverse events were highly frequent among university students after receiving the COVID-19 vaccine; however, there were no life-threatening cases or hospitalizations over two years. A higher number of vaccinations (p &lt; 0.001), female sex (p &lt; 0.001), and lower body mass index (BMI) (p = 0.002) were associated with an increased incidence of adverse events on the day of COVID-19 vaccination or the day after vaccination. Regular breakfast consumption was significantly associated with a decreased incidence of post-vaccination itching (p = 0.019) and abdominal pain and diarrhea (p = 0.042). Sufficient sleep duration was significantly associated with a decreased incidence of post-vaccination abdominal pain and diarrhea (p = 0.042).</p></div><div><h3>Conclusions</h3><p>High frequency of adverse events of COVID-19 mRNA-1273 among Japanese university students was reported. A higher number of shots, female sex, and lower BMI were associated with a higher incidence of adverse events. Regular breakfast and sufficient sleep were associated with fewer adverse events. This study may provide a possible solution to the worldwide problem of vaccine hesitancy.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100516"},"PeriodicalIF":2.7,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000895/pdfft?md5=4db8bcb1b466c26316cdee0ae6bf9177&pid=1-s2.0-S2590136224000895-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety profile assessment of HPV4 and HPV9 vaccines through the passive surveillance system of the Veneto Region (Italy) between 2008 and 2022: A 15-year retrospective observational study","authors":"Diana Dalla Valle ,&nbsp;Roberto Benoni ,&nbsp;Nicola Soriolo ,&nbsp;Chiara Battistella ,&nbsp;Francesca Moretti ,&nbsp;Laura Augusta Gonella ,&nbsp;Stefano Tardivo ,&nbsp;Silvia Colpo ,&nbsp;Sara Montresor ,&nbsp;Francesca Russo ,&nbsp;Michele Tonon ,&nbsp;Filippo Da Re ,&nbsp;Ugo Moretti ,&nbsp;Giovanna Zanoni","doi":"10.1016/j.jvacx.2024.100511","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100511","url":null,"abstract":"<div><p>In Veneto Region, HPV vaccine has been actively offered to 12 year-old females since 2008, and to 12 year-old males since 2015. The study aims to analyze the safety profile of HPV4v and HPV9v vaccines and perform a case-by-case review of conditions of interest.</p><p>Spontaneous reports related to HPV uploaded to the database of the Regional Pharmacovigilance Center between 2008–2022 were included. HPV vaccine doses administered until April 2022 in the Veneto Region were considered to calculate the reporting rate (RR).</p><p>Potential “safety concerns” examined as conditions of interest were included through Standardized MedDRA or preferred terms searching queries. The level of diagnostic certainty was evaluated as per the Brighton Collaboration case definition criteria.</p><p>A total of 637 reports and 1316 Adverse Events Following Immunizations (AEFI) were retrieved: 469 for HPV4v (73.6 %) and 168 for HPV9v (26.4 %). Serious reports were 71 (11.1 %): 49 (10.4 %) for HPV4v and 22 (13.1 %) for HPV9v. The RR for serious events between 2008–2022 was 6.9/100,000 administered doses, with no differences by vaccine type. Females and adults showed higher overall RR compared to males and to children and adolescents (p &lt; 0.001), this result was confirmed by stratifying analysis by vaccine type. One case of Guillain Barré syndrome, anaphylactic shock, thrombocytopenia, Henoch Schoenlein purpura and four generalized seizures were reviewed.</p><p>Vaccinovigilance data from the Veneto Region reaffirm a good safety profile for HPV vaccination and found no vaccine-related unexpected events. Such a detailed analysis may assist healthcare providers to advocate properly for HPV vaccination.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100511"},"PeriodicalIF":2.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000846/pdfft?md5=a4b800a55b0febc3069b87357a66fc43&pid=1-s2.0-S2590136224000846-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness analysis of NVX-CoV2373 COVID-19 vaccination for elderly people in Japan","authors":"Masafumi Kato ,&nbsp;Takayori Ono ,&nbsp;Hisato Deguchi ,&nbsp;Norio Ohmagari ,&nbsp;Ataru Igarashi","doi":"10.1016/j.jvacx.2024.100514","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100514","url":null,"abstract":"<div><h3>Background</h3><p>NVX-CoV2373 is one of the vaccines marketed for COVID-19 prevention in Japan. Information on its cost-effectiveness is important for making well-informed decisions on the future of Japan’s COVID-19 vaccination programme from the public healthcare payer’s perspective. The aim of this study was to evaluate the cost-effectiveness of NVX-CoV2373 vaccination in the elderly Japanese population.</p></div><div><h3>Methods</h3><p>Two analysis populations that included elderly Japanese individuals (aged ≥ 65 years) were defined in this study: those who had not received a COVID-19 vaccine or had not completed a primary vaccination series (i.e., first two vaccinations) with an approved COVID-19 vaccine (analysis population 1), and those who had received two primary vaccinations with an approved COVID-19 vaccine (analysis population 2). A literature-informed Markov model for each analysis population was developed to evaluate the cost-effectiveness of vaccination with NVX-CoV2373 against no vaccination with NVX-CoV2373 from the public healthcare payer’s perspective as a base-case analysis and from the societal perspective as a scenario analysis. Vaccine efficacy was estimated from a phase 3 study of NVX-CoV2373 (EudraCT number: 2020–004123-16). Cost-effectiveness was assessed using a willingness-to-pay threshold of Japanese yen (JPY) 5 million per quality-adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses were also performed.</p></div><div><h3>Results</h3><p>For analysis population 1, NVX-CoV2373 primary and booster vaccinations would reduce costs by JPY 37,647 and prolong QALYs by 0.01601. Therefore, NVX-CoV2373 primary and booster vaccinations were considered to be dominant over no vaccination. For analysis population 2, an NVX-CoV2373 booster vaccination would increase costs by JPY 5010 and prolong QALYs by 0.00550, with the incremental cost-effectiveness ratio of JPY 910,566 per QALY gained.</p></div><div><h3>Conclusions</h3><p>Our analyses suggest that a vaccination strategy with NVX-CoV2373 is cost-effective in the elderly population (aged ≥ 65 years) of Japan<em>.</em></p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100514"},"PeriodicalIF":2.7,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000871/pdfft?md5=c337928f6d3b9ff3d154ff7c5515f295&pid=1-s2.0-S2590136224000871-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141605487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany)","authors":"Frank Kowalzik ,&nbsp;Daniel Teschner ,&nbsp;Margarida Mesquita ,&nbsp;Christian Jensen ,&nbsp;Daniel Schreiner ,&nbsp;Kai Kronfeld ,&nbsp;Marija Tubic-Grozdanis ,&nbsp;Darline Cheatham-Seitz ,&nbsp;Franziska Hettich ,&nbsp;Gianluca Quintini ,&nbsp;Oliver Schoenborn-Kellenberger ,&nbsp;Paula Codó ,&nbsp;Philipp von Eisenhart-Rothe ,&nbsp;Philipp Mann ,&nbsp;Lidia Oostvogels ,&nbsp;Stephan Gehring","doi":"10.1016/j.jvacx.2024.100512","DOIUrl":"https://doi.org/10.1016/j.jvacx.2024.100512","url":null,"abstract":"<div><h3>Background</h3><p>CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW).</p></div><div><h3>Methods</h3><p>Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30^th of June 2021, this study was unblinded and converted to an open label design.</p></div><div><h3>Results</h3><p>Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose.</p></div><div><h3>Conclusion</h3><p>No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.</p><p>Study registration: <u>ClinicalTrials.gov</u> NCT04674189, study period: 23^rd of December 2020 to 8^th of June 2022.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"19 ","pages":"Article 100512"},"PeriodicalIF":2.7,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224000858/pdfft?md5=92a7f2742ef0cd69e9a1686ba30d337d&pid=1-s2.0-S2590136224000858-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}