VaccinePub Date : 2025-07-28DOI: 10.1016/j.vaccine.2025.127527
Maria da Graça Salomão, Caroline de Almeida Leitão Curimbaba, Patrícia Emília Braga, João Italo Dias França, Elizabeth Gonzalez Patino, Fernanda Castro Boulos, José Alfredo de Sousa Moreira, PROFISCOV Study Group
{"title":"Long-term efficacy and immune response of CoronaVac in Brazilian health care workers: Insights from PROFISCOV unblinded trial","authors":"Maria da Graça Salomão, Caroline de Almeida Leitão Curimbaba, Patrícia Emília Braga, João Italo Dias França, Elizabeth Gonzalez Patino, Fernanda Castro Boulos, José Alfredo de Sousa Moreira, PROFISCOV Study Group","doi":"10.1016/j.vaccine.2025.127527","DOIUrl":"10.1016/j.vaccine.2025.127527","url":null,"abstract":"<div><div>Covid-19 remains a global threat due to vaccine-waning immune responses, and the need to update to emerging variants. This study presents the post-unblinding analysis of the PROFISCOV trial (NCT04456595), a double-blind, randomized, placebo-controlled phase 3, among adult healthcare workers (HCWs≥18y). A cohort (<em>N</em> = 12,688) was randomized to receive a two-dose regimen of the inactivated COVID-19 vaccine (CoronaVac) or placebo (1:1), 14 days apart. ANVISA granted emergency use authorization for CoronaVac in January 2021, prompting the study's unblinding. Outcomes included incidence of symptomatic confirmed COVID-19 cases (RT-PCR), immune response over one year, and effects of boosters among the vaccinees. Population (<em>N</em> = 1554) exhibited a reduction in confirmed cases from November 2021, peaking from December 2021 to February 2022, when the Omicron wave prevailed. Mean IgG-RBD titres increased from baseline to the 52nd week. IgG-N titres peaked in the 13th week and declined. The homologous booster enhanced significantly the immune response compared to the heterologous one (Pfizer).</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144713297","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127504
Joann Diray-Arce , Ana C. Chang , Sara Moradipoor , Donato Amodio , Bruce Carleton , Wan-Chun Chang , Nigel W. Crawford , Meagan Karoly , Annmarie Hoch , Kerry McEnaney , Tahir S. Kafil , Mahitha Donthireddy , Sarah K. Steltz , Simon D. van Haren , Asimenia Angelidou , Kinga K. Smolen , Hanno Steen , Jessica Lasky-Su , Huyen Tran , Peter Liu , Karina A. Top
{"title":"Longitudinal Meta-cohort study protocol using systems biology to identify vaccine safety biomarkers","authors":"Joann Diray-Arce , Ana C. Chang , Sara Moradipoor , Donato Amodio , Bruce Carleton , Wan-Chun Chang , Nigel W. Crawford , Meagan Karoly , Annmarie Hoch , Kerry McEnaney , Tahir S. Kafil , Mahitha Donthireddy , Sarah K. Steltz , Simon D. van Haren , Asimenia Angelidou , Kinga K. Smolen , Hanno Steen , Jessica Lasky-Su , Huyen Tran , Peter Liu , Karina A. Top","doi":"10.1016/j.vaccine.2025.127504","DOIUrl":"10.1016/j.vaccine.2025.127504","url":null,"abstract":"<div><div>The International Network of Special Immunization Services (INSIS) was established to investigate the causes and risk factors of rare adverse events following immunizations (AEFIs) and develop immunization strategies for mitigating or preventing risk for individuals with prior AEFIs or at risk of AEFIs. INSIS integrates clinical data with multi-omic technologies (e.g., transcriptomics, proteomics, metabolomics) through a global consortium of clinical networks, leading immunology, pharmacogenomics teams to uncover the molecular mechanisms behind AEFIs. The network ensures accurate and standardized data collection and analysis through rigorous data management and quality assurance processes. INSIS also implements harmonized case definitions and protocols for collecting data and samples related to rare AEFIs, such as myocarditis, pericarditis, and Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT) after COVID-19 vaccinations. This protocol outlines the comprehensive approach to enhance risk-benefit assessments of vaccines across populations, identify actionable biomarkers to inform discovery and development of safe vaccines, and support personalized vaccination strategies.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127504"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711271","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127541
Solomon English , Sofiya Fedosyuk , Francisco Orliacq , Vincent Tem , William Taylor , Nawsad Alam , Zhi Q. Xiang , Luke Thorley , César López-Camacho , Hildegund C. Ertl , Alexander D. Douglas
{"title":"Rabies glycoprotein engineering for improved stability and expression","authors":"Solomon English , Sofiya Fedosyuk , Francisco Orliacq , Vincent Tem , William Taylor , Nawsad Alam , Zhi Q. Xiang , Luke Thorley , César López-Camacho , Hildegund C. Ertl , Alexander D. Douglas","doi":"10.1016/j.vaccine.2025.127541","DOIUrl":"10.1016/j.vaccine.2025.127541","url":null,"abstract":"<div><div>Current rabies vaccines require multiple doses and are relatively expensive, limiting their accessibility. Novel low-cost vaccines capable of inducing a protective antibody response against the rabies virus glycoprotein (RVG) are therefore desirable. Structure-guided engineering of the antigen may enhance its qualitative or quantitative immunogenicity, as may transgene cassette optimisation in the case of vectored vaccines. We investigated the potential of these approaches for the design of improved rabies vaccines.</div><div>We evaluated twelve candidate cassette designs. While codon optimisation enhanced expression <em>in vitro,</em> it did not translate into improved immunogenicity. Co-expression or RVG with rabies matrix protein (RVM) did not detectably affect expression or immunogenicity. Inserting a C-terminal trimerisation domain was detrimental to expression <em>in vitro</em> and did not improve immunogenicity compared to the wild-type comparator. We screened 72 mutant constructs for <em>in vitro</em> expression and pre-fusion stabilisation. Several mutants enhanced expression and/or pre-fusion stability at low pH. Combination of the previously reported H270P mutation with the H419L substitution achieved enhanced stability. An L271Q + H419L double mutant achieved the greatest positive effect upon expression. Neither of double mutants improved immunogenicity compared to wild-type RVG when tested using an mRNA vaccine platform.</div><div>These mutant constructs may be of value for protein subunit vaccines, but full length wild-type RVG may be sufficiently conformationally stable and well-expressed for optimal immunogenicity of adenovirus and mRNA vaccines in mice.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127541"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711258","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127547
Frans Ileana Cuevas
{"title":"Commentary: Processes of pre-clinical and clinical vaccine development public data sharing within the NIAID collaborative influenza vaccine innovation centers (CIVICs)","authors":"Frans Ileana Cuevas","doi":"10.1016/j.vaccine.2025.127547","DOIUrl":"10.1016/j.vaccine.2025.127547","url":null,"abstract":"<div><div>The 2019 coronavirus disease (COVID-19) pandemic increased efforts for rapid data sharing and dissemination among researchers as well as to data repositories. Researchers and studies prioritized data sharing, which increased understanding of SARS-CoV-2's pathology. Eventually, this effort to maximize collaboration and data dissemination, led to the development of mRNA vaccines. This successful effort has highlighted the importance of data sharing and the implementation of data management policies, including the National Institutes of Health's (NIH) Data Sharing Policy of 2023. Moreover, programs such as the National Institute of Allergy and Infectious Diseases (NIAID) funded Collaborative Influenza Vaccine Innovation Centers (CIVICs), have beta-tested this policy, with the help of the Statistical, Data Management and Coordination Center (SDMCC) and its data standards, and deemed it useful. However, the process has also initiated pertinent discussion on potential improvements and optimizations for the <em>future</em> of data sharing. Here, I use the CIVICs data sharing reporting standards and process as a data sharing example, and suggest logistical improvements to propose a better-equipped model for the vaccinology community.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127547"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711272","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.126801
Yoonjae Kang, Fan Zhang, Tara M. Vogt
{"title":"Where do children get vaccinated in the U.S.? Parental experiences, attitudes, and beliefs about place of vaccination with a focus on pharmacies and schools","authors":"Yoonjae Kang, Fan Zhang, Tara M. Vogt","doi":"10.1016/j.vaccine.2025.126801","DOIUrl":"10.1016/j.vaccine.2025.126801","url":null,"abstract":"<div><h3>Objective</h3><div>To assess parental experiences, attitudes, and beliefs about place of pediatric vaccination in the U.S. with a focus on pharmacies and schools.</div></div><div><h3>Methods</h3><div>An online, national survey of 2005 U.S. parents ages 18 years and older was conducted during August 17–25, 2023. Topics included 1) places their children 17 years of age and under had ever been vaccinated, 2) places parents feel comfortable taking their child for vaccination, and 3) parental attitudes, beliefs, and experiences related to vaccination of their child at a pharmacy or school. If the parent had more than one child, the survey randomly selected a reference child.</div></div><div><h3>Results</h3><div>The most frequently reported place of pediatric vaccination was a doctor's office (75.8 %), clinic or health center (23.1 %), and hospital (19.1 %). A smaller proportion of parents reported getting their child vaccinated at a pharmacy (15.9 %), health department clinic (9.8 %), or school (6.6 %). Vaccination at a pharmacy was more commonly reported by parents of 12–17-year-olds (22.9 %) vs. 0–4-year-olds (5.7 %) (<em>p</em>-value<0.0001), those living in urban (16.3 %) vs. rural areas (11.1 %) (<em>p</em>-value = 0.0182), and children with private (20.0 %) vs. public (Medicaid/CHIP) health insurance (12.4 %) (<em>p</em>-value<0.0001). Vaccination at a school was more commonly reported by parents of 12–17-year-olds (9.0 %) vs. 0–4-year-olds (3.2 %) (<em>p</em>-value = 0.0002). Among parents who reported getting their child vaccinated at a pharmacy (<em>n</em> = 318), 92.2 % rated their overall satisfaction level ‘very good’ or ‘good.’ Among parents whose children have gotten vaccinated at school (<em>n</em> = 124), 83.9 % reported their overall satisfaction level to be ‘very good’ or ‘good.’</div></div><div><h3>Conclusions</h3><div>While most children receive their vaccination at a doctor's office, parents who have experience getting their child vaccinated in alternative places of vaccination, such as pharmacies and schools, reported a positive overall satisfaction level. Pharmacy and school vaccination may be acceptable, especially for older children and adolescents.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 126801"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711300","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127540
Fernando L. Leite , Paulo Arruda , Brianna Ford , Dianna Jordan , Luis Giménez-Lirola , Juan Carlos Mora-Díaz , David Bradshaw , Shawn M.D. Bearson
{"title":"Oral live bivalent Salmonella vaccine reduces clinical disease, colonization and fecal shedding of multidrug resistant Salmonella enterica serovar I 4,[5],12:i:-","authors":"Fernando L. Leite , Paulo Arruda , Brianna Ford , Dianna Jordan , Luis Giménez-Lirola , Juan Carlos Mora-Díaz , David Bradshaw , Shawn M.D. Bearson","doi":"10.1016/j.vaccine.2025.127540","DOIUrl":"10.1016/j.vaccine.2025.127540","url":null,"abstract":"<div><div><em>Salmonella enterica</em> serovar I 4,[5],12:i:- is currently the most common serovar identified in U.S. swine clinical cases and is prevalent worldwide. This serovar also ranks among the leading causes of human foodborne salmonellosis and is the most frequently identified multidrug-resistant (MDR; resistance to ≥3 antimicrobial classes) <em>Salmonella</em> serovar in the U.S. Given its importance to both swine health and food safety, the current study evaluated the efficacy of a commercial vaccine containing live attenuated <em>Salmonella enterica</em> serovars Typhimurium and Choleraesuis in pigs challenged with MDR <em>Salmonella</em> I 4,[5],12:i:-. Pigs vaccinated with a single oral dose exhibited significantly reduced diarrhea and lower body temperatures following challenge compared to non-vaccinated pigs (<em>n</em> = 20/group). During the 14-days post-challenge, vaccinated pigs also demonstrated significantly reduced fecal shedding and up to a 2.3-log reduction in intestinal tissue colonization, as well as a significant reduction in the number of pigs colonized, compared to non-vaccinated pigs. Furthermore, weight gain was significantly higher in vaccinated pigs compared to non-vaccinated pigs after challenge. Collectively, these results demonstrate that vaccination significantly reduces clinical disease, fecal shedding, and tissue colonization following challenge with MDR <em>Salmonella</em> I 4,[5],12:i:-, revealing the vaccine to be an effective pre-harvest tool to improve both animal health and food safety.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127540"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144713523","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127548
Stanley Xu , Lina S. Sy , Vennis Hong , Lei Qian , Kimberly J. Holmquist , Katia J. Bruxvoort , Bing Han , Bruno Lewin
{"title":"Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study","authors":"Stanley Xu , Lina S. Sy , Vennis Hong , Lei Qian , Kimberly J. Holmquist , Katia J. Bruxvoort , Bing Han , Bruno Lewin","doi":"10.1016/j.vaccine.2025.127548","DOIUrl":"10.1016/j.vaccine.2025.127548","url":null,"abstract":"<div><h3>Background</h3><div>While prior studies found no clear evidence of an association between COVID-19 vaccination and tinnitus, concerns about a potential link remain. This study assessed the risk of tinnitus following COVID-19 XBB.1.5 vaccination, administered alone or coadministered with influenza vaccine, using the event-dependent self-controlled case series (SCCS) design.</div></div><div><h3>Methods</h3><div>We conducted an SCCS study among individuals aged ≥12 years enrolled at Kaiser Permanente Southern California, with tinnitus events occurring between September 1, 2023, and March 31, 2024. The exposures included Pfizer-BioNTech and Moderna COVID-19 XBB.1.5 vaccines, with or without influenza vaccine coadministration. The primary outcome was first-ever tinnitus (no documented history before September 1, 2023), and the secondary outcome was first-in-1-year tinnitus, identified using ICD-10 code H93.1* in inpatient, emergency department, and outpatient settings. Risk intervals were pre-specified as 1–14 days and 1–28 days after vaccination, with person-time outside the risk interval serving as the control interval. Relative incidences (RI) and 95% confidence intervals (CI) were estimated, adjusting for seasonality by including tinnitus events among non-recipients of COVID-19 XBB.1.5 vaccines and by including calendar month in the SCCS models.</div></div><div><h3>Results</h3><div>With 13,940 first-ever tinnitus events among recipients of COVID-19 XBB.1.5 vaccines, no increased risk was observed within 1–14 or 1–28 days following vaccination in overall analyses. The RI was 0.78 (95% CI: 0.67–0.90) for the 14-day risk interval and 0.87 (95% CI: 0.78–0.96) for the 28-day interval. Subgroup analyses by age and influenza vaccine coadministration status also showed no significant increase in RI. Similarly, no significantly elevated RI was found for first-in-1-year tinnitus in the overall analyses, age-specific analyses, or analyses by coadministration with influenza vaccine.</div></div><div><h3>Conclusion</h3><div>Our findings suggest no increased tinnitus risk following COVID-19 XBB.1.5 vaccination, either administered alone or coadministered with influenza vaccine. These results provide reassuring evidence of the safety of COVID-19 vaccines with respect to tinnitus risk.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127548"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711298","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 : 2025-07-26DOI: 10.1016/j.vaccine.2025.127043
Yoonjae Kang, Fan Zhang, Tara M. Vogt
{"title":"Parental attitudes, beliefs, and experiences related to pediatric COVID-19 vaccination","authors":"Yoonjae Kang, Fan Zhang, Tara M. Vogt","doi":"10.1016/j.vaccine.2025.127043","DOIUrl":"10.1016/j.vaccine.2025.127043","url":null,"abstract":"<div><h3>Objective</h3><div>To assess parental attitudes, beliefs, and experiences related to pediatric COVID-19 vaccination.</div></div><div><h3>Methods</h3><div>An online, national survey of 2005 U.S. parents aged 18 and older was conducted during August 17–25, 2023. Parental attitudes and beliefs about pediatric COVID-19 vaccination, receipt of a COVID-19 vaccination recommendation for their child, and reasons for not getting their child vaccinated against COVID-19 were assessed. Factors associated with child's COVID-19 vaccination were also assessed.</div></div><div><h3>Results</h3><div>Less than half (46.1 %) of responding parents strongly or somewhat agreed that COVID-19 vaccine is generally safe for children; agreement was higher among parents of 12–17-year-olds (54.2 %) vs. 0–4-year-olds (35.4 %), children with private (52.8 %) vs. Medicaid/CHIP health insurance (41.0 %), and those living in urban (54.2 %) vs. rural areas (29.8 %) (<em>p</em>-values<0.0001). Approximately 60 % of parents reported that their child's health care provider (HCP) recommended COVID-19 vaccination for their child, with higher proportions reporting a recommendation among those with 12–17-year-olds (73.1 %) vs. 0–4-year-olds (43.1 %) (<em>p</em>-value<0.0001), children with private (65.6 %) vs. Medicaid/CHIP health insurance (58.2 %) (<em>p</em>-value = 0.0013), and those living in urban (67.3 %) vs. rural areas (51.6 %) (<em>p</em>-value<0.0001). The top three reported reasons for not getting their child vaccinated against COVID-19 were 1) worry about serious/unknown long-term health problems from the vaccine (52.8 %), 2) a belief that COVID-19 vaccination is not effective at preventing COVID-19 (36.3 %), and 3) child/family has already had COVID-19 (19.3 %). Parents who had received COVID-19 vaccine themselves were more likely to vaccinate their child against COVID-19 (received bivalent vaccine dose: OR = 25.8 [15.9, 41.7]; received at least one dose, but not bivalent vaccine dose: OR = 11.1 [6.8, 18.2]).</div></div><div><h3>Conclusions</h3><div>Parental concerns around serious/unknown long-term health problems related to COVID-19 vaccination were observed. In addition, a significant proportion of parents reported not having received a COVID-19 vaccination recommendation. Addressing parents' concerns regarding vaccine safety remains important, especially in rural areas.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127043"},"PeriodicalIF":4.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711299","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 : 2025-07-25DOI: 10.1016/j.vaccine.2025.127549
W. van der Weg , G. von Kreijfelt , L. Davidson , J. Zwaveling , L.E. Visser , F.P.A.M. van Hunsel , A.C. Kant
{"title":"Strengthening spontaneous reporting-based signal detection during a pandemic with cases from electronic health records using a natural language processing tool","authors":"W. van der Weg , G. von Kreijfelt , L. Davidson , J. Zwaveling , L.E. Visser , F.P.A.M. van Hunsel , A.C. Kant","doi":"10.1016/j.vaccine.2025.127549","DOIUrl":"10.1016/j.vaccine.2025.127549","url":null,"abstract":"<div><h3>Introduction</h3><div>During the COVID-19 pandemic, vaccines were rapidly developed, but some potential adverse drug reactions (ADRs) were still undetected at the time of market authorization. The analysis of ADR reports received through the spontaneous reporting system (SRS) remains the cornerstone for safety signal detection. A limitation is that reporting ADRs is voluntary. In this study the added value of electronic health records (EHRs) was explored as an additional source to spontaneous reports, to strengthen safety signal detection concerning COVID-19 vaccines.</div></div><div><h3>Methods</h3><div>The electronic health record adverse event (EHR-AE) search method was developed to enable targeted searches in EHRs using a natural language processing (NLP) tool with text-mining functionalities to identify additional potential cases. Searches were performed in EHRs of two Dutch hospitals concerning several established and non-established (potential) ADRs associated with COVID-19 vaccines. Identified cases were reported to Lareb and analyzed in addition to spontaneous reports for safety signal detection.</div></div><div><h3>Results</h3><div>Thirteen searches were conducted between January 1, 2023, and December 1, 2023, concerning different (potential) ADRs associated with COVID-19 vaccines. For 6 associations at least 1 case was identified, resulting in a total of 41 additional cases reported to Lareb. These cases contributed to the detection of two safety signals concerning COVID-19 vaccines. Two safety signals could have been detected approximately 18 and 2 months earlier, if the EHR-AE method had been implemented during the COVID-19 pandemic.</div></div><div><h3>Conclusion</h3><div>The EHR-AE search method can strengthen and accelerate the signal detection process for potential ADRs associated with COVID-19 vaccination. Future studies should expand to more hospitals, aiming to further evaluate the added value of the method, including for which drug-ADR associations the EHR-AE search method is most beneficial.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127549"},"PeriodicalIF":4.5,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144704477","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 : 2025-07-25DOI: 10.1016/j.vaccine.2025.127542
Yilan Xia , Xiang Guo , Xiaoya Fu , Fengge Wang , Yihan Lu
{"title":"Knowledge, perception, and practice regarding meningococcal vaccination in infants 3–7 months of age: A nationwide cross-sectional study in China","authors":"Yilan Xia , Xiang Guo , Xiaoya Fu , Fengge Wang , Yihan Lu","doi":"10.1016/j.vaccine.2025.127542","DOIUrl":"10.1016/j.vaccine.2025.127542","url":null,"abstract":"<div><h3>Background</h3><div>Meningococcal serogroup distribution evolves globally. In China, meningococcal polysaccharide vaccine (MPSV)-A is included in the National Expanded Program on Immunization (EPI) for infants at 6 months of age, while meningococcal polysaccharide conjugate vaccines (MPCV)-AC/ACYW are classified as non-EPI (self-paid) vaccines administered starting at 3 months of age. This study aimed to investigate the knowledge, perception, and practice of meningococcal vaccines among healthcare practitioners (HCPs) at points of vaccination (POVs) and caregivers of infants aged 3–7 months.</div></div><div><h3>Methods</h3><div>A cross-sectional survey was conducted between January 2023 and December 2024 across 29 provinces in China. A total of 5069 HCPs at POVs and 148,269 caregivers of infants aged 3–7 months were enrolled. Structured questionnaires were distributed to collect data on vaccine knowledge, perception, preferences, and vaccination practice.</div></div><div><h3>Findings</h3><div>Most HCPs (91·9 %) acknowledged the substantial burden of meningococcal disease. However, 99·4 % of HCPs reported uncertainty in meningococcal disease prevention, primarily due to insufficient public awareness (85·3 %). When selecting self-paid meningococcal vaccines, HCPs prioritized protective efficacy (73·1 %) and serogroup coverage (70·5 %), aligning with the priorities of caregivers choosing MPCV-ACYW (78·2 %). Conversely, caregivers choosing MPSV-A or MPCV-AC prioritized safety (42·2 % and 50·6 %, respectively) and cost-effectiveness (52·6 % and 42·7 %, respectively). Moreover, caregivers reported infants receiving the MPCV-ACYW experienced milder irritability and crying, and exhibited better overall safety and tolerability, compared to MPCV-AC (each <em>p</em> < 0·001). Additionally, 35·4 % of infants received simultaneous administration of their first-dose meningococcal vaccine and other vaccines. Simultaneous administration patterns of meningococcal vaccines and other vaccines differed by age and vaccine type.</div></div><div><h3>Interpretation</h3><div>This study is the first to systematically determine the perceptions and practices of meningococcal vaccination from both HCPs and caregivers across provinces in China. Most HCPs acknowledged the necessity of early meningococcal vaccination and MPCV-ACYW effectiveness. The findings indicate a need to strengthen public awareness of meningococcal disease, implement tailored health advocacy, and promote multivalent meningococcal vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127542"},"PeriodicalIF":4.5,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144704397","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}