VaccinePub Date : 2024-11-29DOI: 10.1016/j.vaccine.2024.126545
Dorota Borys , Ronald Smulders , Miwa Haranaka , Takashi Nakano , Gurunadh R. Chichili , Masaki Ebara , Atsuki Hashimoto , Mioko Iwahana , Yuki Oizumi , Jasdeep Nanra , Richard Malley , Shite Sebastian
{"title":"Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naïve Japanese adults: A phase 1 randomized dose-escalation trial","authors":"Dorota Borys , Ronald Smulders , Miwa Haranaka , Takashi Nakano , Gurunadh R. Chichili , Masaki Ebara , Atsuki Hashimoto , Mioko Iwahana , Yuki Oizumi , Jasdeep Nanra , Richard Malley , Shite Sebastian","doi":"10.1016/j.vaccine.2024.126545","DOIUrl":"10.1016/j.vaccine.2024.126545","url":null,"abstract":"<div><h3>Background</h3><div>The burden of pneumococcal diseases remains high in Japan. Pn-MAPS24v is a novel MAPS-based vaccine containing complexes of 24 serotype-specific polysaccharides (PS), non-covalently coupled with fusion protein 1 (CP1). This study evaluated the safety and immunogenicity of different dose levels of Pn-MAPS24v, administered in Japanese adults either subcutaneously (SC) or intramuscularly (IM).</div></div><div><h3>Methods</h3><div>In this phase 1, dose-escalation, observer-blind trial conducted in Japan, 54 pneumococcal vaccine-naïve adults aged 20–49 years (stage 1), and 72 adults aged 65–85 years (stage 2) were sequentially enrolled. In stage 1, participants were randomized 1:1 (SC:IM) to receive a single Pn-MAPS24v dose at one of the dose levels (1 μg, 2 μg, or 5 μg per PS). In stage 2, participants were randomized 3:1 (Pn-MAPS24v:23-valent pneumococcal polysaccharide vaccine [PPSV23]) and 1:1 (SC:IM) to receive a single dose of either Pn-MAPS24v (one of three dose levels), or PPSV23. Solicited adverse events (AEs) were collected through 7 days post-vaccination, and treatment-emergent AEs (TEAEs) up to 1 month post-vaccination. Serotype-specific opsonophagocytic activity titers and immunoglobulin G (IgG) concentrations, as well as anti-CP1 IgG concentrations were measured before and 1 month post-vaccination.</div></div><div><h3>Results</h3><div>No safety or reactogenicity concerns were identified in any age category across groups. No grade 3–4 TEAEs, serious AEs, or deaths were reported. Regardless of the age category, dose level, administration route, or study vaccine, the frequency of reported TEAEs was low and all vaccine-related TEAEs were mild. Pain, tenderness, and fatigue were the most frequently reported solicited AEs. One month post-vaccination, Pn-MAPS24v induced serotype-specific immune responses that were comparable or higher than those elicited by PPSV23. The immune responses were similar after SC and IM administration.</div></div><div><h3>Conclusion</h3><div>Pn-MAPS24v showed an acceptable safety profile and was immunogenic after SC and IM administration, therefore supporting the further development of Pn-MAPS24v in Japan.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT04265911</span><svg><path></path></svg></span></div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126545"},"PeriodicalIF":4.5,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142746146","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}
VaccinePub Date : 2024-11-28DOI: 10.1016/j.vaccine.2024.126521
Ellen K. Link , Alina Tscherne , Gerd Sutter , Emily R. Smith , Marc Gurwith , Robert T. Chen , Asisa Volz , For the Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG)
{"title":"A Brighton collaboration standardized template with key considerations for a benefit/risk assessment for a viral vector vaccine based on a non-replicating modified vaccinia virus Ankara viral vector","authors":"Ellen K. Link , Alina Tscherne , Gerd Sutter , Emily R. Smith , Marc Gurwith , Robert T. Chen , Asisa Volz , For the Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG)","doi":"10.1016/j.vaccine.2024.126521","DOIUrl":"10.1016/j.vaccine.2024.126521","url":null,"abstract":"<div><div>The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) was formed to evaluate the safety and other key features of new platform technology vaccines. This manuscript provides an overview of Modified Vaccinia virus Ankara (MVA)-vectored vaccines and reviews molecular and biological key features of this platform. In particular, this review aims to provide fundamental information about the promising candidate vaccine MVA-MERS-S which has been evaluated successfully in different preclinical animal models and has undergone clinical testing including a phase Ib study involving more than 170 participants.</div><div>Infectious diseases continue to be a major cause of human death worldwide. In this context, emerging zoonotic infectious diseases pose a particular challenge for public health systems. In the last two decades, three different respiratory coronaviruses, including the Middle East respiratory syndrome Coronavirus (MERS-CoV) have emerged. For many years, safe and efficacious vaccines have been a major tool to combat infectious diseases.</div><div>Here, we report on a promising candidate vaccine (MVA-MERS-S) against MERS-CoV based on MVA. Upon application, MVA-MERS-S has been well tolerated and immunogenic, inducing both, cellular and humoral immune responses in different animal models and humans. We demonstrate that the MVA vector platform, with the example of MVA-MERS-S, is a viable and effective tool for producing safe, immunogenic, and efficient vaccines against emerging infectious diseases.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126521"},"PeriodicalIF":4.5,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721486","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}
VaccinePub Date : 2024-11-28DOI: 10.1016/j.vaccine.2024.126477
Donato Amodio , Asimenia Angelidou , Nicola Cotugno , Amy C. Sherman , Ofer Levy , Paolo Palma
{"title":"Biomarkers of vaccine safety and efficacy in vulnerable populations: Lessons from the fourth international precision vaccines conference","authors":"Donato Amodio , Asimenia Angelidou , Nicola Cotugno , Amy C. Sherman , Ofer Levy , Paolo Palma","doi":"10.1016/j.vaccine.2024.126477","DOIUrl":"10.1016/j.vaccine.2024.126477","url":null,"abstract":"<div><div>Vaccination has been a cornerstone of public health, substantially reducing the global burden of infectious diseases, notably evident during the COVID-19 pandemic caused by SARS-CoV-2. However, vulnerable populations (VPs), including those in extreme age groups and those with underlying health conditions, have borne a disproportionate burden of morbidity and mortality from infectious diseases. Understanding vaccine immunogenicity in these populations is crucial for developing effective vaccines. Characterizing vaccine responses in VPs presents unique challenges due to under-vaccination, sub-optimal vaccine responses, and distinct mechanisms of vaccine-induced protection. To address these challenges, experts convened at the 4th International Precision Vaccines Conference in Rome. Co-hosted by the Precision Vaccines Program of Boston Children's Hospital and Ospedale Pediatrico Bambino Gesù, the conference focused on biomarkers of vaccine safety and efficacy in vulnerable populations. Discussions at the conference emphasized the need for multidisciplinary strategies and international collaborations to optimize vaccine development. Key areas of focus included assessing vaccine safety, defining biomarkers for vaccine immunogenicity, developing human in vitro assay models, and accelerating the selection of novel vaccine formulations and adjuvants tailored for vulnerable populations. The conference provided a platform for experts from diverse fields, including immunology, paediatrics, and vaccinology, to exchange ideas and advance research in precision vaccines. This manuscript highlights key concepts discussed at the conference and underscores the importance of precision vaccines in addressing the unique needs of vulnerable populations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126477"},"PeriodicalIF":4.5,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142744014","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}
VaccinePub Date : 2024-11-28DOI: 10.1016/j.vaccine.2024.126548
Michael Edelstein , Haneen Shibli , Jacob Bornstein
{"title":"Differences in knowledge, attitudes and intentions towards HPV vaccination among young adults from diverse socio-cultural groups in Israel: A cross-sectional study","authors":"Michael Edelstein , Haneen Shibli , Jacob Bornstein","doi":"10.1016/j.vaccine.2024.126548","DOIUrl":"10.1016/j.vaccine.2024.126548","url":null,"abstract":"<div><div>In Israel, The Human Papilloma Virus (HPV) vaccine is recommended to both genders up to age 26. Many 18–26 olds missed their opportunity for vaccination during school. Our study described HPV knowledge, attitudes and vaccination intentions among unvaccinated 18–26 Israeli adults across various demographics, aiming to inform future catch-up vaccination strategies.</div><div>We recruited participants through an anonymous survey and collected information about demographics and HPV knowledge, attitudes and intentions using questions from validated questionnaires adapted to the Israeli context, distributed between December 2023–February 2024. We calculated weighted mean knowledge and attitude scores according to age, gender, ethnicity and sexual orientation. We determined factors associated with vaccination knowledge, attitudes and intentions using multivariate linear regressions.</div><div>Of 4324 respondents, 36 % were vaccinated. Of 1994 unvaccinated individuals included in the final analysis, <50 % reported being familiar with HPV. The overall mean weighted HPV knowledge score was 9.5/14 (95 % CI 9.3–9.7). Older participants, Jewish non-Ultra-Orthodox, and those with higher education levels reported higher knowledge scores. Attitudes towards HPV vaccination were generally neutral but tended towards the positive, with an overall mean weighted score of 2.9/5 (95 %CI 2.88–2.95). Variation in attitudes across different demographic groups was minimal.</div><div>Intention to vaccinate within 12 months was low, with <15 % of respondents overall expressing an intention to do so. Factors significantly associated with higher vaccination intention included being Arab, older, female, having multiple sexual partners, and being a student. There was no association between sexual orientation and vaccination intention. Arab participants showed the highest intention to vaccinate despite having the lowest knowledge levels.</div><div>Young adults in Israel demonstrate low HPV awareness and vaccination intention, with minor variations in attitudes across different demographics. Providing more information may be insufficient to increase vaccine uptake in all groups. Future catch-up campaigns should be tailored to barriers specific to different groups.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126548"},"PeriodicalIF":4.5,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720698","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}
VaccinePub Date : 2024-11-27DOI: 10.1016/j.vaccine.2024.126546
Alice Blukacz , Alexandra Obach , Paola Vásquez , Carla Campaña , Catalina Huerta , Yanara Bernal , Báltica Cabieses
{"title":"Determinants of COVID-19 and non-COVID-19 vaccine confidence in low- and middle-income countries: A systematic review of qualitative evidence and thematic synthesis","authors":"Alice Blukacz , Alexandra Obach , Paola Vásquez , Carla Campaña , Catalina Huerta , Yanara Bernal , Báltica Cabieses","doi":"10.1016/j.vaccine.2024.126546","DOIUrl":"10.1016/j.vaccine.2024.126546","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic has shown the immediate risk for global and public health posed by vaccination inequities worldwide. The regions most affected are low- and middle-income countries (LMICs). In addition to systemic challenges, vaccine hesitancy driven by low vaccine confidence has been identified as a threat to vaccine uptake. The aim of this systematic review of qualitative literature is to explore the determinants of COVID-19 and non-COVID-19 vaccine confidence in LMICs.</div></div><div><h3>Methods</h3><div>A systematic review was conducted following the PRISMA and ENTREQ guidelines. The electronic databases Cinahl, Embase, Pubmed, Scopus and Web of Science were searched for qualitative studies focusing on the topic of interest in LMICs published between 2013 and 2023. The quality of the studies was assessed using the Joanna Briggs Institute's Checklist for Qualitative Research. A thematic synthesis was conducted. The study was registered on the Open Science Framework platform.</div></div><div><h3>Findings</h3><div>66 studies were included in the review. Three main determinants of vaccine confidence were identified: (1) General perceptions of the safety and efficacy of vaccines; (2) Information and experience; (3) Trust in healthcare providers, institutions, and systems. General perceptions of vaccine safety and efficacy were similar between COVID-19 and non-COVID-19 vaccines, and doubts regarding vaccine safety were neither new nor exclusive to the COVID-19 vaccine, indicating a persisting challenge. Furthermore, low vaccine confidence was partly determined by broader dynamics of mistrust towards Western countries and institutions, which was reflected for both vaccine groups. While conspiracy theories have been persisting determinants of low confidence, low COVID-19 vaccine confidence was partly determined by what was perceived as a lack of specific information.</div></div><div><h3>Conclusion</h3><div>Persistent challenges to vaccine confidence were identified, rooted in colonial legacies and global health inequities, as well as limited intercultural approaches to building trust with regards to vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126546"},"PeriodicalIF":4.5,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720699","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}
{"title":"Immunoprotective efficacy of Escherichia coli-derived outer membrane vesicles displaying PlpE protein of Pasteurella multocida","authors":"Yajuan Li , Liyi Chen , Junfang Xiao , Keyu Feng , Xinheng Zhang , Yung-Fu Chang , Qingmei Xie","doi":"10.1016/j.vaccine.2024.126532","DOIUrl":"10.1016/j.vaccine.2024.126532","url":null,"abstract":"<div><div><em>Pasteurella multocida</em> (<em>P. multocida</em>), a pathogenic bacterium known to induce duck cholera, stands as a significant contributor to bacterial diseases afflicting the duck industry, causing substantial annual economic losses on a global scale. In this study, the genes encoding the lipoproteins PlpE of <em>P. multocida</em> strain PMWSG-4 was cloned, inserted into the pBAD-ClyA vector, and the recombinant outer membrane vesicles (OMVs) fused with PlpE antigen of <em>P. multocida</em> was expressed by <em>Escherichia coli</em> (<em>E. coli</em>). Ducks immunized with OMV-PlpE had significantly (<em>P</em> < 0.001) increased production of antigen-specific antibodies. Moreover, at 28 days post-immunization, the expression of genes associated with immune response, including interleukin (IL)-2, IL-4, IL-10, and interferon (IFN)-γ in the spleen tissue of immunized ducks were significantly (<em>P</em> < 0.001) up-regulated compared to unimmunized ducks in the control group. And the active serum had significant bactericidal effects against the PMWSG-4 strain (<em>P</em> < 0.001). The protective efficacy of the vaccines was evaluated by leg muscle challenge with 20 LD50 doses of <em>P. multocida</em>, with the recombinant OMV-PlpE conferring 100 % protection. Histopathological examination and tissue bacterial load detection revealed that OMV-PlpE mitigated tissue damage and bacterial colonization to a statistically significant extent (<em>P</em> < 0.001). These findings serve as a valuable reference for the development of vaccines against <em>P. multocida</em>.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126532"},"PeriodicalIF":4.5,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720986","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}
VaccinePub Date : 2024-11-26DOI: 10.1016/j.vaccine.2024.126550
Eliandra da Silveira de Lima , Marcos Otávio Brum Antunes , Jesuely Spieckert de Souza , Marcus H. Jones , Renato T. Stein , Leonardo A. Pinto , Frederico Friedrich , Marcelo Comerlato Scotta
{"title":"Effectiveness of BNT162b2 and CoronaVac against COVID-19-related severe outcomes among children and adolescents: A Brazilian nationwide cohort study","authors":"Eliandra da Silveira de Lima , Marcos Otávio Brum Antunes , Jesuely Spieckert de Souza , Marcus H. Jones , Renato T. Stein , Leonardo A. Pinto , Frederico Friedrich , Marcelo Comerlato Scotta","doi":"10.1016/j.vaccine.2024.126550","DOIUrl":"10.1016/j.vaccine.2024.126550","url":null,"abstract":"<div><h3>Introduction</h3><div>Nationwide databases from large countries may provide real-world evidence about COVID-19 vaccine effectiveness (VE). This study sought to assess the VE of BNT162b2 and CoronaVac against COVID-19-related severe outcomes in school-aged children and adolescents during the Omicron wave of the COVID-19 pandemic in Brazil.</div></div><div><h3>Methods</h3><div>A nationwide population-based cohort study compared the incidence risk ratios (IRRs) of hospitalization due to COVID-19-associated severe acute respiratory syndrome (SARS), need for invasive ventilatory support, and death among school-aged children (age 5 to 11 years) and adolescents (age 12 to 17 years), stratified by vaccination status (none, one, or two doses), in 2022. The period included epidemiological weeks (EW) 10 to 34 for school-aged children and EW 1 to EW 22 for adolescents. Data from all individuals hospitalized due to laboratory-confirmed COVID-19-related SARS were extracted from OpenDATASUS, where individual data including clinical outcomes and vaccination status are available. Vaccine coverage was estimated using data from the Brazilian Ministry of Health “Vacinômetro COVID-19” dashboard.</div></div><div><h3>Results</h3><div>An eligible population of 19,219,424 school-aged children and 22,580,918 adolescents was assessed. For school-aged children, the VE against hospitalization for SARS, invasive ventilatory support, and death after one and two doses was 61 % and 58 %, 62 % and 74 %, and 81 % and 88 %, respectively (all <em>p</em> < 0.01). Among adolescents, the VE against the same outcomes after one and two doses was 55 % and 72 %, 60 % and 78 %, and 83 % and 80 %, respectively (all <em>p</em> < 0.05). CoronaVac was noninferior to BNT162b2 considering all outcomes among fully vaccinated school-aged children, a group that could have received either of the two vaccines.</div></div><div><h3>Conclusions</h3><div>COVID-19 vaccines are effective against severe outcomes in school-aged children and adolescents and are protective against mortality even after a single dose. CoronaVac was not inferior to BNT162b2 in school-aged children.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126550"},"PeriodicalIF":4.5,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720774","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}
VaccinePub Date : 2024-11-25DOI: 10.1016/j.vaccine.2024.126506
Yu Jung Choi , Jaehun Jung , Minsun Kang , Min Joo Choi , Won Suk Choi , Yu Bin Seo , Hak-Jun Hyun , Yoonsun Yoon , Young June Choe , Geum Joon Cho , Young-Eun Kim , Dong Wook Kim , Hye Seong , Eliel Nham , Jin Gu Yoon , Ji Yun Noh , Joon Young Song , Woo Joo Kim , Hee Jin Cheong
{"title":"The risk of pregnancy-related adverse outcomes after COVID-19 vaccination: Propensity score-matched analysis with influenza vaccination","authors":"Yu Jung Choi , Jaehun Jung , Minsun Kang , Min Joo Choi , Won Suk Choi , Yu Bin Seo , Hak-Jun Hyun , Yoonsun Yoon , Young June Choe , Geum Joon Cho , Young-Eun Kim , Dong Wook Kim , Hye Seong , Eliel Nham , Jin Gu Yoon , Ji Yun Noh , Joon Young Song , Woo Joo Kim , Hee Jin Cheong","doi":"10.1016/j.vaccine.2024.126506","DOIUrl":"10.1016/j.vaccine.2024.126506","url":null,"abstract":"<div><h3>Introduction</h3><div>Coronavirus 2019 (COVID-19) vaccination rates in pregnant women remain low owing to safety concerns. When evaluating vaccine safety, comparisons with unvaccinated individuals may lead to healthy vaccinee bias. This study aimed to investigate the association between mRNA-based COVID-19 vaccination and pregnancy-related adverse outcomes compared with influenza vaccination.</div></div><div><h3>Methods</h3><div>A propensity score-matched cohort study was conducted using the National Health Insurance Service insurance claims database, combined with COVID-19 and influenza vaccination registration data from the Korea Disease Control and Prevention Agency. Based on the age, comorbidities, insurance type, region, hospital type, gestational age at vaccination, and primiparity, the COVID-19 vaccination-only group and influenza vaccination-only group were matched in a 1:3 ratio, while both (COVID-19 and influenza) vaccination group and influenza vaccination-only group were also matched in a 1:3 ratio. Logistic regression analysis was used to calculate odds ratios (ORs) with 95 % confidence intervals (CIs) between the two groups.</div></div><div><h3>Results</h3><div>From October 18, 2021, to March 3, 2022, 71,902 pregnant women were identified, and the vaccination records of 67,522 individuals were verified. Among them, 610 received the COVID-19 vaccination only, 49,952 received the influenza vaccination only, and 2405 received both vaccines. In the COVID-19 vaccination-only group, the risk of large for gestational age was higher than in the influenza vaccination-only group (OR = 2.285, 95 % CI = 1.155–4.522, <em>P</em> = 0.018). In the group that received both vaccinations, the risk of premature birth was higher (OR = 1.365, 95 % CI = 1.124–1.656, <em>P</em> = 0.002) than that in the influenza vaccination-only group but lower than the domestic baseline incidence rates. No significant differences were observed in other maternal and neonatal outcomes.</div></div><div><h3>Conclusion</h3><div>mRNA-based COVID-19 vaccination in pregnant women is safe without a remarkable increase in adverse maternal and neonatal outcomes. Given the high morbidity and mortality rates of COVID-19 in pregnant women, it is reasonable to recommend COVID-19 vaccination for pregnant women.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126506"},"PeriodicalIF":4.5,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142707343","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}
VaccinePub Date : 2024-11-24DOI: 10.1016/j.vaccine.2024.126516
Natalie E. Dean , M. Elizabeth Halloran , Veronika I. Zarnitsyna
{"title":"Poor vaccine responders mask the true trend in vaccine effectiveness against progression to severe disease","authors":"Natalie E. Dean , M. Elizabeth Halloran , Veronika I. Zarnitsyna","doi":"10.1016/j.vaccine.2024.126516","DOIUrl":"10.1016/j.vaccine.2024.126516","url":null,"abstract":"<div><div>Vaccines can reduce an individual's risk of infection and their risk of progression to severe disease given infection. The latter effect is less commonly estimated but is relevant for vaccine impact modeling and cost-effectiveness calculations. Using a motivating example from the COVID-19 literature, we note how vaccine effectiveness against progression to severe disease can appear to increase from below 0 % to over 70 % within 8 months. With true biological strengthening of this magnitude being unlikely, we use a mathematical modeling framework to identify parameter combinations where this phenomenon can occur. Fundamental features are an immunocompetent population with high initial protection against infection, contrasted with a vulnerable subpopulation with poor vaccine response against infection and progression. As a result, the earliest infections are among those with the weakest protection against severe disease. This work highlights methodological challenges in isolating a vaccine's effect on progression to severe disease after infection, and it signals the need for refined analytical methods to adjust for differences between the vaccinated infected and the unvaccinated infected populations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"43 ","pages":"Article 126516"},"PeriodicalIF":4.5,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702070","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}
VaccinePub Date : 2024-11-24DOI: 10.1016/j.vaccine.2024.126540
Francisco Castillo-Zunino , Kyra A. Hester , Pinar Keskinocak , Dima Nazzal , Hannah K. Smalley , Matthew C. Freeman
{"title":"Associations between family planning, healthcare access, and female education and vaccination among under-immunized children","authors":"Francisco Castillo-Zunino , Kyra A. Hester , Pinar Keskinocak , Dima Nazzal , Hannah K. Smalley , Matthew C. Freeman","doi":"10.1016/j.vaccine.2024.126540","DOIUrl":"10.1016/j.vaccine.2024.126540","url":null,"abstract":"<div><h3>Background</h3><div>Increasing childhood vaccination, family planning, healthcare access, and women's empowerment are targets of the Sustainable Development Goals (SDG). Barriers to healthcare access impede vaccination; tackling goals holistically could create larger gains than siloed efforts. We studied Nepal, Senegal, and Zambia to test the association between childhood vaccinations and other SDG indicators to identify clustered deprivations. We quantified how under-immunized children with few – or no – vaccines and their mothers were vulnerable in SDG areas.</div></div><div><h3>Methods</h3><div>We analyzed Demographic and Health Surveys from Nepal, Senegal, and Zambia. Through ordinal logistic regressions, controlling for household/mother's characteristics, we identified strong predictors of the number of vaccine doses one-year-old children received. Through bootstrapping and optimal propensity scores matching, we compared children with no or few vaccine doses (0–2 doses in early 2000s, or 0–4 in late 2010s) to children who received eight doses (DTP1–3, MVC1, Pol1–3, and BCG vaccines).</div></div><div><h3>Findings</h3><div>Mothers of children who received eight doses were 14–30 % more likely than mothers of children with few or no doses to have accessed a health facility in the last year (95 % CIs were 16–44 % in Nepal 2001, −5 % to 33 % Nepal 2016, 3–26 % Senegal 2005, 1–31 % Senegal 2019, 9–38 % Zambia 2001–02, 7–36 % Zambia 2018), knew on average 0.7–1.5 more contraceptive methods (0.9–2.0 Nepal 2005, 0.1–1.5 Nepal 2016, 0.6–1.7 Senegal 2005, 0.2–1.7 Senegal 2019, 0.1–1.4 Zambia 2001–02, 0.5–1.4 Zambia 2018), and had 10–22 % higher literacy rates (12–32 % Nepal 2001, −7 % to 36 % Nepal 2016, 10–26 % Senegal 2005, −3 to 22 % Senegal 2019, −4 % to 28 % Zambia 2001–02, 5–36 % Zambia 2018).</div></div><div><h3>Interpretation</h3><div>Children with few or no vaccine doses and their mothers were behind in access to family planning, healthcare, and education compared to fully vaccinated children and their mothers. Such differences can further impede immunizations; integrated education and health services are needed to improve vaccination outcomes.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"44 ","pages":"Article 126540"},"PeriodicalIF":4.5,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142707276","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}