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Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data BNT162b2 COVID-19 疫苗的安全性和致反应性:开发、上市后监测和真实世界数据
IF 4.8 4区 医学 Pub Date : 2024-02-26 DOI: 10.1080/21645515.2024.2315659
Frank van den Ouweland, Nicola Charpentier, Özlem Türeci, Ruben Rizzi, Federico J. Mensa, Claudia Lindemann, Shanti Pather
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public acce...
严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)引发的大流行促使创新者、疫苗开发商、监管机构和其他利益相关者采取紧急行动,以确保公众能够接种 SARS-CoV-2 疫苗。
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引用次数: 0
Awareness regarding human papillomavirus and willingness for vaccination among college students with or without medical background in Guizhou Province 贵州省有无医学背景的大学生对人类乳头瘤病毒的认识及接种意愿
IF 4.8 4区 医学 Pub Date : 2024-01-08 DOI: 10.1080/21645515.2023.2295992
Qiongdan Hu, Yuanqin Rui, Jing Jiang, Jing Yang, HanYun Yao, XiaoFang Yang, Zhe Liu, Chencui Li, Hong Pan, Yan Xie
This cross-sectional epidemiological study aimed to investigate awareness regarding human papillomavirus (HPV) and willingness for vaccination among college students with or without medical backgro...
这项横断面流行病学研究旨在调查有或没有医学背景的大学生对人类乳头瘤病毒(HPV)的认识以及接种疫苗的意愿。
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引用次数: 0
The urban-poor vaccination: Challenges and strategies in low-and-middle income countries 城市贫民的疫苗接种:中低收入国家的挑战和战略
IF 4.8 4区 医学 Pub Date : 2024-01-02 DOI: 10.1080/21645515.2023.2295977
Boston Zimba, Samuel Mpinganjira, Takondwa Msosa, Fanuel Meckson Bickton
Vaccination is one of the success stories of public health. The benefit of vaccination goes beyond individual protection to include promoting population well-being, improving cognitive development,...
疫苗接种是公共卫生的成功典范之一。接种疫苗的益处不仅限于保护个人,还包括促进人口福祉、改善认知发展、提高免疫力、减少疾病风险、改善健康状况和提高生活质量。
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引用次数: 0
Willingness of college students to receive COVID-19 heterologous vaccination in Taizhou, China. 台州市大学生接种新冠肺炎异源疫苗的意愿。
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-01-06 DOI: 10.1080/21645515.2022.2158012
Hui Shao, Xiao-Qing Lin, Yan Chen, Li Lv, Chen-Qian Ying, Tao-Hsin Tung, Jian-Sheng Zhu

This study aimed to determine the willingness of college students to choose COVID-19 heterologous vaccination and its associated influencing factors in Taizhou, China. A population-based, self-administered online questionnaire was conducted from March 15 to 17, 2022. Of the 2,463 participants who had received the invitation, 1,821 responded to the survey (response rate = 73.9%). Only 14% (86/614) of those willing to receive a booster would chose a heterologous vaccination; the perception of better effectiveness of a COVID-19 heterologous vaccination booster was the significant factor (X2 = 22.671, p < .001). Additionally, female college students'older age (χ2 = 7.523, P = .023), major of medical (χ2 = 6.294, P = .012), and better perceived effectiveness of COVID-19 heterologous vaccination booster (χ2 = 22.659, P < .001), were more willing to receive heterologous booster doses. Chinese college students have a strong willingness to receive booster shots, but the percentage of those willing to receive a heterologous vaccine is only 14.0%, and the lack of understanding of its effectiveness is an important factor in the low proportion of heterologous vaccine selection. Health education, public health awareness, and the disclosure of heterologous vaccine information can help improve the public's understanding of heterologous vaccines and provide them with more choices.

本研究旨在确定台州市大学生选择新冠肺炎异源疫苗接种的意愿及其相关影响因素。2022年3月15日至17日进行了一项基于人群的自我管理在线问卷调查。在收到邀请的2463名参与者中,1821人对调查做出了回应(回复率 = 73.9%)。只有14%(86/614)的愿意接受加强针的人会选择异源疫苗接种;认为新冠肺炎异源疫苗接种加强剂效果更好是重要因素(X2 = 22.671,第页 2. = 7.523,P = .023),医学专业(χ2 = 6.294,第页 = .012),以及更好地感知新冠肺炎异源疫苗接种加强针的有效性( = 22.659,P
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引用次数: 0
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. mRNA-1283 SARS-CoV-2成人疫苗安全性和免疫原性的1期随机临床试验中期分析
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-04-19 DOI: 10.1080/21645515.2023.2190690
Patrick Yassini, Mark Hutchens, Yamuna D Paila, Lorraine Schoch, Anne Aunins, Uma Siangphoe, Robert Paris

This interim analysis of an ongoing phase 1 randomized clinical trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1283, a next-generation SARS-CoV-2 messenger RNA (mRNA)-based vaccine encoding two segments of the spike protein (i.e. receptor binding and N-terminal domains). Healthy adults aged 18-55 years (n = 104) were randomized (1:1:1:1:1) to receive two doses of mRNA-1283 (10, 30, or 100 µg) or mRNA-1273 (100 µg) administered 28 days apart, or a single dose of mRNA-1283 (100 µg). Safety was assessed and immunogenicity was measured by serum neutralizing antibody (nAb) or binding antibody (bAb) responses. At the interim analysis, no safety concerns were identified and no serious adverse events, adverse events of special interest, or deaths were reported. Solicited systemic adverse reactions were more frequent with higher dose levels of mRNA-1283 than with mRNA-1273. At day 57, all dose levels of the 2-dose mRNA-1283 regimen (including the lowest dose level [10 µg]) induced robust nAb and bAb responses that were comparable to those of mRNA-1273 (100 µg). mRNA-1283 was generally safe in adults, with all dose levels of the 2-dose regimen (10, 30, and 100 µg) eliciting similar immunogenicity as the 2-dose mRNA-1273 regimen (100 µg).Clinical Trials Registration: Clinicaltrials.gov, NCT04813796.

这项对正在进行的1期随机临床试验的中期分析评估了mRNA-1283的安全性、反应原性和免疫原性,mRNA-1282是一种新一代基于严重急性呼吸系统综合征冠状病毒2型信使核糖核酸(mRNA)的疫苗,编码刺突蛋白的两个片段(即受体结合和N-末端结构域)。18-55岁的健康成年人 年(n = 104)随机(1:1:1:1:1)接受两剂mRNA-1283(10、30或100 µg)或mRNA-1273(100 µg)28 间隔天,或单剂量的mRNA-1283(100 µg)。通过血清中和抗体(nAb)或结合抗体(bAb)反应评估安全性并测量免疫原性。在中期分析中,没有发现任何安全问题,也没有报告严重不良事件、特别关注的不良事件或死亡。与mRNA-1273相比,mRNA-1283的剂量水平越高,引起的全身不良反应越频繁。在第57天,2剂mRNA-1283方案的所有剂量水平(包括最低剂量水平[10 µg])诱导了与mRNA-1273(100 µg)。mRNA-1283在成人中通常是安全的,在2剂方案的所有剂量水平下(10、30和100 µg)引起与2剂量mRNA-1273方案相似的免疫原性(100 µg)。临床试验注册:Clinicaltrials.gov,NCT04813796。
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引用次数: 0
Multi-level quality improvement strategies to optimize HPV vaccination starting at the 9-year well child visit: Success stories from two private pediatric clinics. 从9岁健康儿童就诊开始,优化HPV疫苗接种的多层次质量改进策略:来自两家私立儿科诊所的成功案例。
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-02-16 DOI: 10.1080/21645515.2022.2163807
Sherri Zorn, Gabrielle Darville-Sanders, Thuy Vu, Amy Carter, Katie Treend, Char Raunio, Anjali Vasavada

HPV vaccination rates remain far below goal, leaving many adolescents unprotected against future HPV-related cancers. Starting HPV vaccine at age 9 may improve timely preteen vaccination. The "HPV Vax at 9" Quality Improvement intervention paired HPV vaccination with 9- and 10-year well child visits and was piloted at two pediatric clinics (n = 9 sites) in Washington between 2018 and 2022. Supporting interventions included standardized immunization schedule posters in exam rooms, electronic medical record supports, provider and staff training, strong provider recommendations, printed educational resources, and peer-to-peer champion coaching. Provider and clinic acceptance was high with HPV vaccine administration occurring at 68-86% of the 9- and 10-year well child visits. During the first year, HPV initiation rates at age 9-10 increased by 30% or more at each clinic. Sustained improvements in initiation and series completion were seen with completion at age 11-12 rising as much as 40% from 22 to 62%. Downward pressure of the COVID-19 pandemic on HPV vaccination rates was mitigated. Pairing HPV vaccine with 9- and 10-year well child visits, posting the standardized immunization schedule, and instituting EMR supports for HPV at 9 may be effective and sustainable strategies to simplify clinic workflows and increase timely HPV vaccination.

HPV疫苗接种率仍远低于目标,使许多青少年无法预防未来与HPV相关的癌症。从9岁开始接种HPV疫苗可以提高学龄前疫苗接种的及时性。“9岁时的HPV Vax”质量改善干预措施将HPV疫苗接种与9岁和10岁健康儿童就诊配对,并在两个儿科诊所进行了试点(n = 9个地点)。支持性干预措施包括在检查室张贴标准化免疫接种时间表海报、电子病历支持、提供者和工作人员培训、强有力的提供者建议、印刷教育资源和同伴冠军辅导。提供者和诊所的接受率很高,在9岁和10岁健康儿童就诊中,接种HPV疫苗的比例为68-86%。在第一年,9-10岁的HPV发病率在每个诊所增加了30%或更多。启动和系列完成率持续改善,11-12岁的完成率从22%上升到62%,高达40%。新冠肺炎疫情对HPV疫苗接种率的下行压力得到缓解。将HPV疫苗与9岁和10岁健康儿童就诊配对,公布标准化免疫计划,并在9岁时为HPV建立EMR支持,可能是简化临床工作流程和增加及时HPV疫苗接种的有效和可持续的策略。
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引用次数: 0
Effectiveness of COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis. 2019冠状病毒病辉瑞- biontech (BNT162b2) mRNA疫苗在12-17岁青少年中的有效性:一项系统综述和荟萃分析
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-06-05 DOI: 10.1080/21645515.2023.2214495
Patrick Dmc Katoto, Jacques L Tamuzi, Amanda S Brand, Diana M Marangu, Liliane N Byamungu, Charles S Wiysonge, Glenda Gray

The rapid emergence of COVID-19 variants of concern (VOCs) has hindered vaccine uptake. To inform policy, we investigated the effectiveness of the BNT162b2 vaccination among adolescents against symptomatic and severe COVID-19 diseases using mostly real-world data (15 studies). We searched international databases until May 2022 and used Cochrane's risk of bias tools for critical appraisal. Random effects models were used to examine overall vaccine effectiveness (VE) across studies (general inverse-variance) and the effect of circulating VOCs on VE (log relative ratio and VE). Meta-regression assessed the effect of age and time on VE (restricted-maximum likelihood). BNT162b2 VE against PCR-confirmed SARS-CoV-2 was 82.7% (95%CI: 78.37-87.31%). VE was higher for severe (88%) than non-severe (35%) outcomes and declining over time improved following booster dose in omicron era [73%(95%CI:65-81%)]. Fully vaccinated adolescents are protected from COVID-19 circulating VOCs by BNT162b2 especially for the need of critical care or life support.

新冠肺炎变异毒株(VOCs)的迅速出现阻碍了疫苗的接种。为了向政策提供信息,我们主要使用真实世界的数据(15项研究)调查了BNT162b2疫苗在青少年中对有症状和严重新冠肺炎疾病的有效性。我们搜索了国际数据库,直到2022年5月,并使用Cochrane的偏见风险工具进行批判性评估。随机效应模型用于检验研究中的总体疫苗有效性(VE)(一般逆方差)和循环挥发性有机物对VE的影响(对数相对比和VE)。荟萃回归评估了年龄和时间对VE(受限最大似然)的影响。BNT162b2对经PCR证实的严重急性呼吸系统综合征冠状病毒2型的VE为82.7%(95%可信区间:78.37-87.31%)。在奥密克戎时代,重症(88%)患者的VE高于非重症(35%)患者,随着时间的推移,VE的下降在加强剂量后有所改善[73%(95%置信区间:65-81%)]。BNT162b2保护完全接种疫苗的青少年免受新冠肺炎循环VOCs的影响,特别是在需要重症监护或生命支持的情况下。
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引用次数: 0
Parental preferences for rotavirus vaccination for their children under 5 years old in China: A discrete choice experiment. 中国父母对5岁以下儿童接种轮状病毒疫苗的偏好:一个离散选择实验
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-02-15 DOI: 10.1080/21645515.2023.2179222
Wenwen Ma, Liujin Zhang, Deyu Ren, Xiaoqing Meng, Jia Yin, Qiang Sun

Rotavirus vaccination is the most effective means to prevent rotavirus gastroenteritis, but its coverage in China is not ideal. We aimed to explore parental preferences for rotavirus vaccination for their children under 5years old to improve vaccination coverage. A Discrete Choice Experiment was conducted online on 415 parents with at least one child under 5years old in 3 cities. Five attributes including vaccine effectiveness, protection duration, risk of mild side-effects, out-of-pocket costs, and time required for vaccination were identified. Each attribute was set at three levels. Mixed-logit models were used to measure parental preferences and the relative importance of vaccine attributes. The optimal vaccination strategy was also explored. 359 samples were included in the analysis. The impacts of the vaccine attribute levels on vaccine choice were all statistically significant (p < .01), except for 1-hour vaccination time. The risk of mild side-effects was the most important factor influencing vaccination. The time required for vaccination was the least important attribute. The largest increase in vaccination uptake (74.45%) occurred with decreased the vaccine risk of mild side-effects from 1/10 to 1/50. The predicted vaccination uptake of the optimal vaccination scenario was 91.79%. When deciding about vaccination, parents preferred the rotavirus vaccination with lower risk of mild side-effects, higher effectiveness, longer protection duration, 2-hour vaccination time and lower cost. The authorities should support enterprises to develop vaccines with lower side-effects, higher effectiveness and longer protection duration in the future. We call for appropriate government subsidies for the rotavirus vaccine.

轮状病毒疫苗接种是预防轮状病毒肠胃炎的最有效手段,但在我国的覆盖率并不理想。我们旨在探索父母对5岁以下儿童轮状病毒疫苗接种的偏好,以提高疫苗接种覆盖率。一项离散选择实验在三个城市的415名至少有一个5岁以下孩子的父母身上进行。确定了五个属性,包括疫苗有效性、保护期、轻度副作用风险、自付费用和疫苗接种所需时间。每个属性都设置为三个级别。混合logit模型用于衡量父母的偏好和疫苗属性的相对重要性。还探讨了最佳疫苗接种策略。分析中包括359个样本。疫苗属性水平对疫苗选择的影响均具有统计学意义(p
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引用次数: 0
Temporal association between COVID-19 vaccination and Raynaud's phenomenon: A case series. 新冠肺炎疫苗接种与雷诺现象的时间关联:一个病例系列。
IF 4.8 4区 医学 Pub Date : 2023-12-31 Epub Date: 2023-04-17 DOI: 10.1080/21645515.2023.2199653
Marcus Lisy, Nikolaus Urban, Sophie Brunner-Ziegler, Benedikt Weber, Wolfgang M Bauer, Eva Dassler, Renate Koppensteiner, Alessandra Handisurya

COVID-19 vaccine-related adverse events are mostly minor to moderate, and serious events are rare. Single cases of Raynaud's phenomenon (RP) in temporal proximity to COVID-19 vaccination have been reported. Demographic data, medical history, and detailed information regarding vaccination status and RP characteristics were obtained from patients with confirmed RP after COVID-19 vaccination. Fifteen participants reported the initial manifestation of RP, which occurred in 40% after the first, in 33% after the second, and in 27% after the third vaccination. RP development and occurrence of episodes were not linked to any specific vaccine type. New onset of disease was observed in 40% of the vaccinees after BNT162b2, in 33% after mRNA-1273, and in 27% after ChAdOx1 vaccination. Three out of four participants with preexisting RP prior to COVID-19 vaccination reported aggravation in frequency and intensity after immunization. Although COVID-19 vaccination is pivotal in controlling the pandemic, the observed temporal association between vaccine administration and RP occurrence warrants global activities to support pharmacovigilance for the detection of adverse reactions, one of which may include RP.

新冠肺炎疫苗相关不良事件大多为轻度至中度,严重事件罕见。据报道,在新冠肺炎疫苗接种时间附近出现雷诺现象(RP)的单个病例。从新冠肺炎疫苗接种后确诊RP的患者中获得人口统计学数据、病史以及有关疫苗接种状态和RP特征的详细信息。15名参与者报告了RP的最初表现,第一次接种后40%、第二次接种后33%和第三次接种后27%出现RP。RP的发展和发作与任何特定的疫苗类型无关。在BNT162b2接种后,40%的接种者观察到新发疾病,在mRNA-1273接种后,33%的接种者和在ChAdOx1接种后,27%的接种者出现新发疾病。新冠肺炎疫苗接种前已有RP的参与者中,四分之三的人报告免疫接种后的频率和强度加重。尽管新冠肺炎疫苗接种在控制大流行方面至关重要,但观察到的疫苗接种与RP发生之间的时间关联保证了开展全球活动,支持药物警戒以检测不良反应,其中之一可能包括RP。
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引用次数: 0
A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal. 一项随机、观察者盲、对照的III期临床试验,在尼泊尔东部的健康志愿者中评估白喉类毒素疫苗与破伤风类毒素伤寒结合疫苗的安全性和免疫非劣效性。
IF 4.8 4区 医学 Pub Date : 2023-12-31 DOI: 10.1080/21645515.2023.2203634
Shipra Chaudhary, Gauri Shankar Shah, Nisha Keshary Bhatta, Prakash Poudel, Basant Rai, Surendra Uranw, Prashant Mani Tripathi, Basudha Khanal, Anup Ghimire, Nikita Rai, Birendra Prasad Gupta, Sridhar Vemula, T Anh Wartel, Sushant Sahastrabuddhe, Tarun Saluja

Typhoid remains one of the major serious health concerns for children in developing countries. With extremely drug-resistant cases emerging, preventative measures like sanitation and vaccination, including typhoid conjugate vaccines (TCV) remain the mainstay in its prevention and control. Different types of TCVs are being developed to meet the global demand. This report outlines the results from a study done to assess the immunogenicity and safety of Vi-Diphtheria toxoid (Vi-DT) TCV in Nepal. The study was a randomized, active-controlled, immunological non-inferiority and safety study. Eligible participants from Sunsari and Morang districts of eastern Nepal were randomized into 4 study groups (A-D) within 3 age strata (6 months to <2 years, 2 to <18 years, and 18 to 45 years). Groups A to C received a single dose (25 μg) of Vi-DT test vaccine from any of the 3 lots, while group D received the comparator, Typbar-TCV®, Vi-tetanus toxoid (Vi-TT) vaccine (25 μg) in 1:1:1:1 ratio and evaluated at 4 weeks postvaccination with 6 months follow-up. Amongst 400 randomized participants, anti-Vi-IgG seroconversion rates for all age strata in Vi-DT pooled groups (A+B+C) were 100.00% (97.5% CI 98.34-100.00) vs 98.99% (97.5% CI 93.99-99.85) in Vi-TT group (D) at 4 weeks. Comparable safety events were reported between the groups. Three serious adverse events (1 in Vi-DT; 2 in Vi-TT group) were reported during the 6 months follow-up, none being related to the investigational product. Thus, Vi-DT vaccine is safe, immunogenic, and immunologically non-inferior to Vi-TT when analyzed at 4 weeks postvaccination.

伤寒仍然是发展中国家儿童的主要严重健康问题之一。随着极端耐药病例的出现,卫生和疫苗接种等预防措施,包括伤寒结合疫苗(TCV),仍然是其预防和控制的支柱。正在开发不同类型的TCV以满足全球需求。本报告概述了一项评估Vi-DT TCV在尼泊尔的免疫原性和安全性的研究结果。该研究是一项随机、主动对照、免疫学非劣效性和安全性研究。来自尼泊尔东部Sunsari和Morang地区的合格参与者被随机分为3个年龄层(6 月至
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引用次数: 0
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Human Vaccines & Immunotherapeutics
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