Vaccine最新文献

{"title":"Longitudinal safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in children aged 4–11 years with juvenile-onset autoimmune inflammatory rheumatic diseases: A prospective multicenter study","authors":"","doi":"10.1016/j.vaccine.2024.126426","DOIUrl":"10.1016/j.vaccine.2024.126426","url":null,"abstract":"<div><div>This prospective, longitudinal, multicenter study assessed the safety and efficacy of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine among children 4–11 years-old with autoimmune inflammatory rheumatologic disease (AIIRD), compared to healthy controls. The study was conducted from 11/2021–12/2022 at 4 tertiary pediatric rheumatology units in Israel. Participants received at least 2 vaccine doses. Safety analysis included adverse events and disease activity measures. Efficacy was assessed by COVID-19 infection rates. Immunogenicity was evaluated in a subset of participants using anti- receptor binding domain antibody titers. Thirty-one children with AIIRD and 45 immunocompetent controls with similar baseline characteristics were included. Safety profile was favorable, with mild or no adverse events reported. The adverse event rates were similar in the AIIRD and control groups after the first (27 (60 %) vs. 14 (45.2 %), <em>p</em> = 0.2977) and the second vaccine doses (22 (49.0 %) vs. 18 (58.1 %), <em>p</em> = 0.5799), respectively. AIIRD activity remained stable and low after vaccination. Breakthrough COVID-19 infection rates were similar between groups, with 15 (48.4 %) in the AIIRD vs. 25 (55.6 %) in the control group (<em>p</em> = 0.7029). All reported COVID-19 infections in the AIIRD group and 18 (72 %) in the control group were symptomatic (<em>p</em> = 0.033), although symptoms were generally mild, with no severe disease. The safety of the BNT162b2 COVID-19 vaccine was excellent in children ages 4–11 years with AIIRD and healthy controls. Efficacy between groups was similar.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing HPV vaccine uptake in girls and boys – A qualitative analysis of Canadian school-based vaccination programs","authors":"","doi":"10.1016/j.vaccine.2024.126425","DOIUrl":"10.1016/j.vaccine.2024.126425","url":null,"abstract":"<div><div>The purpose of this study was to better understand barriers and enabling conditions for HPV vaccination in school-based vaccination programs in Canada. Semi-structured interviews were conducted by telephone or in person with parents, nurses, and school staff (<em>n</em> = 50) in three Canadian provinces. Interviews explored views on HPV and HPV vaccination, strengths and weaknesses of the school-based HPV vaccination programs and proposed interventions to increase uptake. Interview transcripts were coded and analyzed thematically using the socio-ecological model. Participants had positive views towards HPV vaccination and school-based offer. They identified barriers and enabling conditions at the individual and interpersonal level (e.g., knowledge, attitudes, behaviours of – and relationships between – parents, nurses, and school personnel), at the organizational level (e.g., allocated resources, information provision, process to ensure informed consent, vaccination setting and environment) and at the community and policy level (e.g., social group values and norms, media coverage around the HPV vaccine). Participants also suggested strategies to reduce identified barriers (e.g., communication interventions, simpler inform consent process). Different layers of barriers and enabling conditions of HPV vaccination in school settings were identified. Tailored interventions remain key to enhance vaccine acceptance and uptake.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446452","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":"Modelling the epidemiological impact of maternal respiratory syncytial virus (RSV) vaccination in Australia","authors":"","doi":"10.1016/j.vaccine.2024.126418","DOIUrl":"10.1016/j.vaccine.2024.126418","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) is a leading cause of respiratory illness among infants. A maternal RSV vaccine that protects young infants has recently been approved for registration in Australia. We estimated the population benefits of a future year-round maternal RSV vaccination program in terms of prevented RSV infections and hospitalisations in Australia.</div></div><div><h3>Methods</h3><div>We described RSV transmission using an age-structured compartmental model calibrated to Australian aggregated monthly RSV-coded hospitalisations in children aged &lt;5 years. We accounted for mother and infant interactions in the model to capture herd effects more realistically. Using the model, we estimated the annual age-specific RSV infections and hospitalisations prevented for a range of assumptions for vaccine efficacy, coverage, and durability to estimate the future impact of year-round maternal RSV vaccination on infants and the wider population.</div></div><div><h3>Results</h3><div>Assuming base case vaccine efficacy, 6 months duration of protection and 70% coverage, RSV hospitalisations were predicted to fall by 60% (from 3.0 to 1.2 per 100 persons) in infants aged &lt;3 months and 40% (from 1.9 to 1.1 per 100 persons) in 3–5-month-olds. These benefits were primarily due to direct protection to infants of vaccinated mothers. This vaccine program was predicted to reduce the population-level RSV infection by about 4%. Coverage and duration assumptions were influential, with higher coverage leading to larger declines in infants &lt;6 months, and increased duration of protection leading to additional declines in infection and hospitalisation risk in older infants aged 6–8 months.</div></div><div><h3>Conclusions</h3><div>With vaccine uptake similar to that achieved for other maternal vaccines in Australia, a year-round RSV maternal vaccination program is predicted to approximately halve the number of RSV hospitalisations in infants younger than 6 months. There was a small herd effect predicted in the base case but potential for larger benefits if vaccine coverage or the duration of protection exceeds base case assumptions.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446449","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":"Oral paratuberculosis vaccine efficacy and mucosal immunity in cattle","authors":"","doi":"10.1016/j.vaccine.2024.126447","DOIUrl":"10.1016/j.vaccine.2024.126447","url":null,"abstract":"<div><div><em>Mycobacterium avium</em> subsp. <em>paratuberculosis</em> (MAP) primarily invades ruminants' small intestine via the Peyer's patches in the ileum and jejunum. Despite ongoing efforts to develop effective MAP vaccines, the effects of live-attenuated vaccines on mucosal immunity remain poorly understood. Previous studies indicate that the <em>BacA</em> oral vaccine confers localized protection against MAP in the ileum and ileocecal valve of calves, but not in the jejunum. This protection correlates with heightened levels of peripheral blood immune cells exhibiting pro-inflammatory and memory traits. This study aimed to evaluate immune responses induced by oral BacA vaccination in the ileum and jejunum Peyer's patches, comparing protection at both sites through mucosal immune cell profiling and RNA-seq transcriptome analyses. It represents the first exploration of mucosal immune responses in Peyer's patches following oral MAP vaccination.</div><div>Oral <em>BacA</em> immunization increased CD4 + IFNγ+ and CD4 + TNFα+ cell frequencies, along with the T effector memory to T central memory cell ratio, in the ileum and jejunum of <em>BacA</em>-vaccinated animals challenged with wildtype MAP, compared to the infection control group challenged solely with wildtype MAP. Immune cells isolated from the ileum of vaccinated-challenged animals exhibited significant upregulation in <em>IFNγ</em>, <em>IP-10</em>, <em>TNFα</em>, <em>IL-2</em>, <em>IL-15</em>, and <em>IL-17</em> expression upon restimulation compared to the uninfected control group, whereas minimal differences were observed in the jejunum under similar conditions. RNA-seq data further indicated a more robust host response in the ileum across all experimental groups. Gene ontology analyses revealed genes associated with increased phagocytic and apoptotic activities in the vaccinated-challenged group.</div><div>Overall, the <em>BacA</em> oral vaccine's effectiveness appears to vary primarily due to differences in antigen-specific gene expression between the ileum and jejunum, with the ileum showing a more robust host response. Understanding these effects on young calves' mucosal immunity and how live vaccines modulate immune responses is crucial for advancing mucosal vaccine development against MAP.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446451","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":"Bacillus Calmette-Guérin vaccination induces a trained innate immunity phenotype in adults over 50 years of age: A randomized trial in Guinea-Bissau","authors":"","doi":"10.1016/j.vaccine.2024.126439","DOIUrl":"10.1016/j.vaccine.2024.126439","url":null,"abstract":"<div><h3>Background</h3><div>The beneficial effects of Bacillus Calmette-Guérin (BCG) as an intervention against non-mycobacterial infections have been extensively studied in randomized trials. These non-specific effects have been linked to a heterologous increase of pro-inflammatory cytokine production by innate immune cells. It is unknown if BCG induces such responses in older individuals from TB-endemic countries.</div></div><div><h3>Methods</h3><div>In a single-blinded trial in Guinea-Bissau, 40 adults over 50 years of age were randomized 1:1 in a block of 40 to intradermal injection of BCG-Japan (intervention) or solvent (placebo). Production of interleukin (IL)-1β, IL-6, IL-10, interferon (IFN)-γ and tumor necrosis factor (TNF)-α was measured by ELISA in supernatant of peripheral blood mononuclear cells stimulated with <em>Mycobacterium tuberculosis</em> and heterologous pathogens. The trial was registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT02953327</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>Between January 25 and March 7, 2017, 40 individuals were randomized. Two months after vaccination, BCG-Japan recipients (<em>n</em> = 11) had higher production of IFN-γ to <em>M. tuberculosis</em> stimulation (Geometric mean ratio (GMR): 3·91 [95 % Confidence Interval (CI), 1·53–9·96]) and increased release of the pro-inflammatory innate cytokines IL-1β, IL-6 and TNF-α to non-specific stimuli (GMR TNF-α: 1·47 [95 % CI, 0·98–2·19]) than their controls (<em>n</em> = 13). Both the specific and non-specific responses were more pronounced among those with a positive QuantiFERON at baseline.</div></div><div><h3>Interpretation</h3><div>BCG-Japan can induce a trained immunity phenotype in older adults. These effects were particularly strong in previously <em>M. tuberculosis</em> exposed individuals. Future randomized trials are needed to determine BCG's potential to protect the older populations from infections-driven morbidity and mortality.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intranasal booster with SARS-CoV-2 RBD protein fused to E. coli enterotoxin a subunit after primary mRNA vaccination in mice","authors":"","doi":"10.1016/j.vaccine.2024.126448","DOIUrl":"10.1016/j.vaccine.2024.126448","url":null,"abstract":"<div><div>The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2019 led to the coronavirus infection diseases 2019 (COVID-19) pandemic, significantly impacting global public health and the economy. Numerous COVID-19 vaccines based on the receptor binding domain (RBD) of SARS-CoV-2 spike protein have been developed, utilizing various protein expression platforms and adjuvant systems. In a previous study, we reported using the direct fusion of the A subunit of type IIb <em>E. coli</em> heat-labile enterotoxin with the SARS-CoV-2 RBD protein (RBD-LTA) as an intranasal vaccine candidate (Hsieh et al., 2023). In this study, we investigated the effects of an intranasal booster of RBD-LTA/RBD mixture proteins after one or two doses of intramuscular bivalent BA.4/5 mRNA vaccination over 17 and 35 weeks. Our results indicate that the intranasal RBD-LTA/RBD mixture proteins booster maintains high levels of anti-RBD IgG and neutralizing antibodies, comparable to those elicited by a two-dose mRNA vaccination regimen. An additional RBD-LTA/RBD mixture proteins booster significantly increased antibody titers, demonstrating the potential of this approach for long-term immunity against SARS-CoV-2. Our findings suggest that combining primary mRNA vaccination with an intranasal RBD-LTA/RBD mixture proteins booster can effectively sustain antibody levels over extended periods, providing a promising strategy for long-term protection against SARS-CoV-2 and its variants.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pediatric COVID-19 vaccine hesitancy among pregnant and post-partum women: A mixed-method study","authors":"","doi":"10.1016/j.vaccine.2024.126420","DOIUrl":"10.1016/j.vaccine.2024.126420","url":null,"abstract":"<div><h3>Background</h3><div>This study aims to understand factors contributing to pediatric COVID-19 vaccine hesitancy among pregnant and postpartum adults.</div></div><div><h3>Method</h3><div>The study used targeted intercept advertising on Facebook, Twitter, and Instagram to recruit a panel of 3600 pregnant and postpartum US adults. Data were collected between December 2021 and April 2022 (i.e., before the introduction of pediatric COVID-19 vaccines in the U.S.). We used logistic regression to understand factors associated with pregnant and postpartum women's hesitancy towards getting children &lt;5 vaccinated against COVID-19. Poststratification weights were applied to analyses to promote the representativeness of the sample. We also conducted a qualitative thematic analysis to determine the reasons for pediatric vaccine hesitancy.</div></div><div><h3>Results</h3><div>Nearly half (45.6 %) of pregnant or postpartum women were hesitant to vaccinate their child against COVID-19. Vaccine hesitancy was lower among those who had a high perceived susceptibility to COVID-19, had increased perceived severity of COVID-19, and increased perceived benefits of the COVID-19 vaccine. Perceived barriers related to long-term side effects of vaccines were positively associated with hesitancy to vaccinate children. Older women, women in urban areas, and those born outside the US were less likely to be hesitant to vaccinate children &lt;5 against COVID-19. Compared to respondents with a high school education or less, the odds of pediatric vaccine hesitancy were higher among respondents with some college. Pregnant and postpartum women who were hesitant about getting children &lt;5 vaccinated cited the following reasons for hesitancy: concerns about the vaccine, lack of evidence on vaccine safety, and the COVID-19 vaccine is not necessary for children.</div></div><div><h3>Conclusion</h3><div>Our findings suggest that public health messages to promote the COVID-19 vaccine for young children should focus on the risks and consequences of the disease and share data on the effectiveness of the vaccine in preventing severe COVID-19-related outcomes.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142446450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cancer fatalism is associated with HPV vaccine uptake among Hispanic emerging adult women in the US","authors":"","doi":"10.1016/j.vaccine.2024.126417","DOIUrl":"10.1016/j.vaccine.2024.126417","url":null,"abstract":"<div><h3>Objective</h3><div>Despite the availability of the Human Papillomavirus (HPV) vaccine, only a small percentage of Hispanic emergent adults in the United States have actually had the vaccination. Due to cancer fatalism, some Hispanic emerging adults may perceive fewer benefits from the HPV vaccine, regardless of its positive health effects. The aim of this study was to determine the relationship between cancer fatalism, knowledge of HPV-associated cancers, and HPV vaccination among Hispanic emerging adult women.</div></div><div><h3>Study design</h3><div>Between August and December of 2020, a cross-sectional study was conducted among Hispanic college women aged 18 to 26. A complete case study was conducted with 689 participants. Using an adjusted logistic regression model, the potential factors associated with HPV vaccine uptake were identified. The current research was approved by the Institutional Review Boards of the participating universities.</div></div><div><h3>Results</h3><div>Only 55.6 % of the study population had received at least one dose of the HPV vaccine. The study found that HPV vaccine uptake was positively associated with HPV associated cancer knowledge (aOR = 1.32; 95 % CI = 1.18, 1.47) and was inversely associated with cancer fatalism (aOR = 0.97; 95 % CI = 0.94, 1.00).</div></div><div><h3>Conclusion</h3><div>According to the results of our study, the HPV vaccination rate among Hispanic emerging adult women is low, and it is necessary to identify the factors that influence vaccination rates. There is a critical, unmet need for innovative approaches to improve HPV vaccination in this population and mitigate the incidence of HPV-related cancers.</div></div><div><h3>Implications</h3><div>Multiple intervention strategies are required to increase vaccination rates among this population. This study suggests implementing culturally tailored health promotion initiatives that reduce fatalistic beliefs among this population. Furthermore, developing a culturally tailored, age-specific HPV vaccine education and promotion program to increase HPV-associated cancer knowledge among Hispanic emerging adults.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MVA-BN vaccine effectiveness: A systematic review of real-world evidence in outbreak settings","authors":"","doi":"10.1016/j.vaccine.2024.126409","DOIUrl":"10.1016/j.vaccine.2024.126409","url":null,"abstract":"<div><div><strong>Background</strong>: Mpox is a disease endemic to Central and West Africa. It caused outbreaks in non-endemic countries, mainly in 2022. The endemic Democratic Republic of Congo is currently experiencing its largest outbreak yet. The vaccine Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) is approved for active immunization against mpox and smallpox. Since the outbreak in 2022, real-world studies have assessed MVA-BN's vaccine effectiveness (VE) against mpox, and this systematic literature review aims to summarize the most current evidence.</div><div><strong>Methods</strong>: Medline (via PubMed), Embase, and LILACS were searched, as well as grey literature sources and publications' bibliographies to identify observational studies published between 1/Jan/2022 and 28/Feb/2024 that estimate the VE of MVA-BN against mpox or provide risk measures that allow calculation of these VE estimates. Data were presented descriptively in tables and text; the methodological quality of included records was assessed using NHLBI/NIH quality assessment tools.</div><div><strong>Results</strong>: The literature search identified 16 records that fit the inclusion criteria. The studies took place in high-income countries and were heterogeneous in design, setting, and definition of at-risk populations. MVA-BN VE estimates against mpox infection were assessed. Where the study population was exclusively or primarily those receiving pre-exposure prophylactic vaccination, the adjusted VE estimates ranged from 35 % to 86 % (<em>n</em> = 8 studies) for one dose and from 66 % to 90 % (<em>n</em> = 5) for two doses. Where only post-exposure prophylactic vaccination was assessed, adjusted VE estimates were reported for one dose only at 78 % and 89 % (<em>n</em> = 2). Additionally, MVA-BN reduced the risk of mpox-related hospitalization in one study and the severity of mpox clinical manifestations in two studies.</div><div><strong>Conclusions</strong>: Despite heterogeneity in study design, setting, and at-risk populations, the reported VE estimates against mpox infection demonstrated the effectiveness of one or two doses of MVA-BN in the context of an outbreak across multiple countries.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441711","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":"Participant-reported neurological events following immunization in the Canadian National Vaccine Safety Network-COVID-19 vaccine (CANVAS-COVID) study","authors":"","doi":"10.1016/j.vaccine.2024.126445","DOIUrl":"10.1016/j.vaccine.2024.126445","url":null,"abstract":"<div><h3>Introduction</h3><div>The Canadian National Vaccine Safety Network (CANVAS) conducted active participant-based surveillance for adverse events following immunization during the COVID-19 vaccine campaign. This study evaluated the association between COVID-19 vaccination and neurological adverse events.</div></div><div><h3>Methods</h3><div>Participants were invited to complete online surveys to report health events that prevented daily activities and/or required medical attention within 7 days after COVID-19 vaccination or 7 days prior to the survey (unvaccinated controls); follow-up surveys were sent 7 months later. Neurological events were health events where the most severe symptom reported was ≥1 of: numbness/tingling, loss of taste or smell, vision loss, facial weakness/paralysis, seizure, weakness/paralysis of arms or legs, confusion, change in personality or behavior, or difficulty with urination or defecation. Data were extracted from the CANVAS-COVID database for analysis.</div></div><div><h3>Results</h3><div>Completed survey responses were received from 15,273 unvaccinated controls, 758,619 dose 1 recipients, 406,884 dose 2 recipients, and 126,586 dose 3 recipients. Rates of neurological events ranged from 15.9 (95 % CI 13.6–18.4) per 10,000 dose 1 ChAdOx1 recipients to 8.4 (6.5–10.8) and 7.9 (5.7–11.0) per 10,000 dose 3 mRNA-1273 and BNT162b2 recipients, respectively. Multivariable regression adjusted for age, sex, previous SARS-CoV-2 infection, and baseline health status showed an increased risk of neurological event among ChAdOx1 dose 1 recipients versus controls (adjusted OR 2.3, 95 % CI 1.2–4.3), but not among mRNA vaccine recipients after any dose. Risk of anaesthesia/paresthesia were increased following ChAdOx1 dose 1 (aOR 4.7, 1.7–13.1), and consistently but not statistically significantly higher following any dose of either mRNA vaccine. Risk of loss of smell/taste was decreased among recipients of any dose of either mRNA vaccine versus controls.</div></div><div><h3>Conclusions</h3><div>The results support the safety of COVID-19 vaccines while confirming reported associations between ChAdOx1 dose 1 and neurological events. Participant-based AEFI surveillance is a useful component of post-market surveillance programs.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":4.5,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441826","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}