Vaccines

疫苗
  • 文章类型: Journal Article
    国家免疫计划(NIP)于1980年在埃塞俄比亚引入。到2023年,NIP将疫苗的数量从6种增加到14种以上。然而,关于新疫苗引进和其他疫苗相关事项的决定没有在全国范围内进行系统审议.因此,需要建立一个国家机构来审议疫苗和疫苗接种问题,除了全球免疫咨询小组之外,在过去的十年中得到了强调。本文介绍了埃塞俄比亚NITAG的建立和成就。E-NITAG成立于2016年,在为新疫苗引入提供建议和改善常规疫苗的交付方面保持积极作用。外部评估表明,E-NITAG具有高度的功能,在加强埃塞俄比亚的疫苗接种实践中发挥了关键作用。特别是在COVID-19大流行期间。缺乏专门的秘书处工作人员是将电子NITAG的作用扩大到满足卫生部的要求之外的主要瓶颈。必须通过建立一个秘书处来加强E-NITAG,该秘书处最终可以成长为一个独立的机构,以解决NIP需要解决的复杂的疫苗相关问题。
    The National Immunization Program (NIP) was introduced in Ethiopia in 1980. The NIP has expanded the number of vaccines from six to more than 14 in 2023. However, decisions on new vaccine introduction and other vaccine-related matters were not systematically deliberated nationally. Thus, the need to establish a national body to deliberate on vaccine and vaccination matters, in addition to the global immunization advisory groups, has been emphasized in the last decade. This article presents the establishment and achievements of the Ethiopian NITAG. The E-NITAG was established in 2016 and maintained its active role in providing recommendations for new vaccine introduction and improving the delivery of routine vaccines. The external assessment indicated the E-NITAG was highly functional and played a critical role in enhancing the vaccination practice in Ethiopia, especially during the COVID-19 pandemic. The absence of a dedicated secretariat staff was the major bottleneck to expanding the role of the E-NITAG beyond responding to MOH requests. The E-NITAG must be strengthened by establishing a secretariat that can eventually grow as an independent institution to address complex vaccine-related issues the NIP needs to address.
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  • 文章类型: Journal Article
    冠状病毒(COVID-19)大流行强调了基于mRNA的疫苗的关键作用,适应性强,易于制造,和安全的预防方法。基于mRNA的治疗正在成为治疗多种疾病的希望途径,包括传染病,癌症,自身免疫性疾病,遗传性疾病,和罕见的疾病。尽管如此,mRNA的体内递送由于其不稳定性而面临挑战,次优交货,以及引发不希望的免疫反应的可能性。在这种情况下,开发有效的药物递送系统,特别是纳米颗粒(NPs),是最重要的。具有生物物理和化学特性,易于表面定制,这些NP已证明在体内的mRNA递送增强,并导致几种基于NP的制剂被批准用于临床.尽管取得了这些进步,发展精致的必要性,有针对性的NP递送系统仍然势在必行。这篇综述全面调查了生物,翻译,NPs介导的mRNA疗法在预防和治疗多种疾病方面的临床进展。通过解决加强现有方法的关键因素,它旨在为精确和有效的基于mRNA的治疗干预措施的未来发展提供信息.
    The coronavirus (COVID-19) pandemic has underscored the critical role of mRNA-based vaccines as powerful, adaptable, readily manufacturable, and safe methodologies for prophylaxis. mRNA-based treatments are emerging as a hopeful avenue for a plethora of conditions, encompassing infectious diseases, cancer, autoimmune diseases, genetic diseases, and rare disorders. Nonetheless, the in vivo delivery of mRNA faces challenges due to its instability, suboptimal delivery, and potential for triggering undesired immune reactions. In this context, the development of effective drug delivery systems, particularly nanoparticles (NPs), is paramount. Tailored with biophysical and chemical properties and susceptible to surface customization, these NPs have demonstrated enhanced mRNA delivery in vivo and led to the approval of several NPs-based formulations for clinical use. Despite these advancements, the necessity for developing a refined, targeted NP delivery system remains imperative. This review comprehensively surveys the biological, translational, and clinical progress in NPs-mediated mRNA therapeutics for both the prevention and treatment of diverse diseases. By addressing critical factors for enhancing existing methodologies, it aims to inform the future development of precise and efficacious mRNA-based therapeutic interventions.
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  • 文章类型: Journal Article
    在含有Omicron的助推器后,实体器官移植受者中变体中和的耐久性尚不清楚。我们报告说,在第一个二价助推器后3个月,XBB.1.5中和逐渐减弱,通过第二次助推器改进;混合免疫提高了峰值,和中和的持续时间。在3至6个月时增强似乎对于维持中和是必要的。
    Durability of variant neutralization in solid organ transplant recipients following Omicron-containing boosters is unknown. We report wane in XBB.1.5 neutralization by 3 months following a first bivalent booster, improved by a second booster; hybrid immunity improved peak, and duration of neutralization. Boosting at 3 to 6 months appears necessary to maintain neutralization.
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  • 文章类型: Journal Article
    非洲猪瘟病毒在家猪和野猪中引起致命的出血性疾病,目前已获得许可的商业疫苗仅在越南可用。亚单位疫苗的开发由于缺乏关于保护性抗原以及合适的递送系统的信息而变得复杂。我们先前的工作表明,使用腺病毒初免和改良的痘苗病毒增强病毒对八个非洲猪瘟病毒基因进行了载体分析,可以在病毒的毒性基因型I分离株攻击后预防致命疾病。这里,我们鉴定了这8种抗原,这些抗原对于观察到的保护作用是必需的,并证明腺病毒初免和腺病毒加强也可以诱导针对I型非洲猪瘟病毒的保护性免疫应答.用表达部分适合于基因型II病毒的个别非洲猪瘟病毒基因的腺病毒库进行免疫接种并不能抵御基因型IIGeorgia2007/1毒株的攻击,这表明可能需要不同的抗原来诱导遗传上不同的病毒的交叉保护。
    目的:非洲猪瘟病毒在家猪中引起致命的出血性疾病,自2007年以来已经杀死了欧洲和亚洲的数百万只动物。由于病毒的复杂性和对保护性免疫的了解不足,针对非洲猪瘟的安全有效亚单位疫苗的开发一直存在问题。在之前的研究中,我们证明,使用两种不同的病毒载体疫苗平台提供的8种不同病毒基因的复杂组合可以保护家猪免受致命疾病的侵害。在这项研究中,我们表明,八个基因中的三个是保护所必需的,一个病毒载体就足够了,显著降低疫苗的复杂性。不幸的是,这种组合并不能预防目前爆发的非洲猪瘟病毒株,这表明,开发真正有效的非洲猪瘟疫苗需要更多的工作来鉴定免疫原性和保护性病毒蛋白。
    African swine fever virus causes a lethal hemorrhagic disease in domestic swine and wild boar for which currently licensed commercial vaccines are only available in Vietnam. Development of subunit vaccines is complicated by the lack of information on protective antigens as well as suitable delivery systems. Our previous work showed that a pool of eight African swine fever virus genes vectored using an adenovirus prime and modified vaccinia virus boost could prevent fatal disease after challenge with a virulent genotype I isolate of the virus. Here, we identify antigens within this pool of eight that are essential for the observed protection and demonstrate that adenovirus-prime followed by adenovirus-boost can also induce protective immune responses against genotype I African swine fever virus. Immunization with a pool of adenoviruses expressing individual African swine fever virus genes partially tailored to genotype II virus did not protect against challenge with genotype II Georgia 2007/1 strain, suggesting that different antigens may be required to induce cross-protection for genetically distinct viruses.
    OBJECTIVE: African swine fever virus causes a lethal hemorrhagic disease in domestic pigs and has killed millions of animals across Europe and Asia since 2007. Development of safe and effective subunit vaccines against African swine fever has been problematic due to the complexity of the virus and a poor understanding of protective immunity. In a previous study, we demonstrated that a complex combination of eight different virus genes delivered using two different viral vector vaccine platforms protected domestic pigs from fatal disease. In this study, we show that three of the eight genes are required for protection and that one viral vector is sufficient, significantly reducing the complexity of the vaccine. Unfortunately, this combination did not protect against the current outbreak strain of African swine fever virus, suggesting that more work to identify immunogenic and protective viral proteins is required to develop a truly effective African swine fever vaccine.
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  • 文章类型: Journal Article
    许多病原体通过粘膜部位进入宿主。因此,因此,通过粘膜部位的局部中和干扰病原体进入是预防疾病的有效策略。粘膜施用的疫苗具有在粘膜部位诱导保护性免疫应答的潜力。这份手稿深入研究了粘膜疫苗接种的一些最新进展,特别关注佐剂技术的进步以及这些佐剂在增强疫苗抗呼吸道病原体功效中的作用。它强调了呼吸道粘膜免疫系统的解剖学和免疫学复杂性,强调粘膜分泌型IgA和组织固有记忆T细胞在局部免疫反应中的重要性。我们进一步讨论了通过传统的肠胃外疫苗接种方法诱导的免疫应答与粘膜给药策略,并探索通过粘膜途径免疫提供的保护性优势。
    Many pathogens enter the host through mucosal sites. Thus, interfering with pathogen entry through local neutralization at mucosal sites therefore is an effective strategy for preventing disease. Mucosally administered vaccines have the potential to induce protective immune responses at mucosal sites. This manuscript delves into some of the latest developments in mucosal vaccination, particularly focusing on advancements in adjuvant technologies and the role of these adjuvants in enhancing vaccine efficacy against respiratory pathogens. It highlights the anatomical and immunological complexities of the respiratory mucosal immune system, emphasizing the significance of mucosal secretory IgA and tissue-resident memory T cells in local immune responses. We further discuss the differences between immune responses induced through traditional parenteral vaccination approaches vs. mucosal administration strategies, and explore the protective advantages offered by immunization through mucosal routes.
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  • 文章类型: Journal Article
    背景:疫苗数量的增加和免疫程序的复杂性,随着传染病流行病学的不断变化,需要一种系统的方法来评估疫苗有效性(VE)。本研究提出了一项初步调查,以建立韩国的VE评估框架,重点是国家免疫计划。
    方法:专家意见是通过针对关键利益相关者的两轮在线调查收集的。第一轮由两个多项选择题和两个开放式问题组成。第二轮是定量调查,通过分析第一轮调查的结果得出了基于五个领域的17份问卷。
    结果:结果强调了政府主导的VE评估系统以及建立多学科评估组织的必要性和紧迫性。关键考虑因素包括人员,预算,数据集成,法律标准,和监控系统增强。
    结论:这些发现为政策制定者提供了有价值的见解,强调合作的必要性,财政支持,和强有力的数据管理,以制定循证疫苗接种政策。
    BACKGROUND: The increasing number of vaccines and the complexity of immunization programs, along with continuous changes in the epidemiology of infectious diseases, necessitate a systematic approach to vaccine effectiveness (VE) evaluation. This study presents a preliminary survey to establish a VE evaluation framework in Korea, focusing on the National Immunization Program.
    METHODS: Experts\' opinions were collected through a two-round online survey targeting key stakeholders. The first round consisted of two multiple-choice questions and two open-ended questions. The second round was a quantitative survey with 17 questionnaires based on five domains derived by analyzing the results of the first-round survey.
    RESULTS: The results emphasize the necessity and urgency of a government-led VE evaluation system and the establishment of a multidisciplinary evaluation organization. Key considerations include personnel, budget, data integration, legal standards, and surveillance system enhancements.
    CONCLUSIONS: These findings provide valuable insights for policymakers, emphasizing the need for collaboration, financial support, and robust data management in developing evidence-based vaccination policies.
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  • 文章类型: Journal Article
    本研究考虑了一个假设的全球儿科疫苗市场,其中多个协调实体代表购买力不同的国家做出最佳采购决策。每个实体都旨在提高其国家的负担能力,同时为疫苗生产商保持一个有利可图的市场。本研究分析了几个因素对承受能力和盈利能力的影响,包括做出采购决策的非合作协调实体的数量,为分层定价目的对国家进行分组的细分市场的数量,生产者如何收回固定生产成本,以及协调实体的采购顺序。该研究依赖于一个框架,实体使用三阶段优化过程与疫苗生产商进行顺序谈判,该过程解决了一个MIP和两个LP问题,以确定最佳采购计划和每剂价格,从而最大限度地为实体国家节省资金,并为疫苗生产商获利。该研究的结果挑战了当前的疫苗市场动态,并为协调购买者的互动提供了新的替代策略。生产者,和协调实体,以提高非合作市场的承受能力。关键结果表明,协调实体与疫苗生产商谈判的顺序以及后者如何恢复其固定成本投资可以显着影响盈利能力和负担能力。此外,低收入国家可以通过协调许多细分市场的实体通过分层定价来采购疫苗,从而更经济地满足其需求。相比之下,中高收入国家通过拥有更少和更广泛的细分市场的实体进行采购,从而提高了其可负担性。当生产者提供数量折扣时,根据其国家的收入递减水平对实体进行优先排序的采购订单提供了更高的机会来提高负担能力和利润。
    This study considers a hypothetical global pediatric vaccine market where multiple coordinating entities make optimal procurement decisions on behalf of countries with different purchasing power. Each entity aims to improve affordability for its countries while maintaining a profitable market for vaccine producers. This study analyzes the effect of several factors on affordability and profitability, including the number of non-cooperative coordinating entities making procuring decisions, the number of market segments in which countries are grouped for tiered pricing purposes, how producers recover fixed production costs, and the procuring order of the coordinating entities. The study relies on a framework where entities negotiate sequentially with vaccine producers using a three-stage optimization process that solves a MIP and two LP problems to determine the optimal procurement plans and prices per dose that maximize savings for the entities\' countries and profit for the vaccine producers. The study\'s results challenge current vaccine market dynamics and contribute novel alternative strategies to orchestrate the interaction of buyers, producers, and coordinating entities for enhancing affordability in a non-cooperative market. Key results show that the order in which the coordinating entities negotiate with vaccine producers and how the latter recuperate their fixed cost investments can significantly affect profitability and affordability. Furthermore, low-income countries can meet their demands more affordably by procuring vaccines through tiered pricing via entities coordinating many market segments. In contrast, upper-middle and high-income countries increase their affordability by procuring through entities with fewer and more extensive market segments. A procurement order that prioritizes entities based on the descending income level of their countries offers higher opportunities to increase affordability and profit when producers offer volume discounts.
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  • 文章类型: Journal Article
    背景:COVID-19大流行对包括卫生人力在内的卫生系统造成了极大的压力,基本卫生服务和疫苗接种覆盖率。我们检查了免疫接种和妇幼保健(MCH)服务的中断,大流行期间对个人福祉和医疗保健服务的关注,以及与医疗保健提供者(HCP)自我报告的创伤或倦怠相关的因素。
    方法:在2022年3月至4月,我们对印度尼西亚两个省的HCP进行了横断面调查。参与COVID-19或常规免疫和MCH服务的HCP是从区/市卫生局登记名单中随机选择的。我们描述性地分析了HCP经历的服务中断以及创伤,大流行期间的倦怠和对个人福祉和医疗保健提供的担忧。进行多变量逻辑回归分析以确定与创伤或倦怠相关的因素。
    结果:我们招募了604名HCPs。将工作人员从常规卫生服务调动到COVID-19应对职责是服务中断的关键原因(87.9%)。实施了社区外联和任务转移等战略,以克服干扰。64.1%的HCP报告了大流行期间的创伤或倦怠,23.5%的人报告精神或情绪健康状况恶化。与创伤或倦怠相关的因素包括COVID-19免疫接种(调整OR(aOR)2.54,95%CI1.08至5.94);与未参与疫苗接种计划相比,COVID-19免疫接种和常规免疫接种的交付(aOR2.42,95%CI1.06至5.52);工作场所治疗不良(aOR2.26,95%CI1.51至3.38),患者对免疫应答较低。
    结论:HCP经历了服务中断,创伤和倦怠以及实施的策略,以最大程度地减少对服务提供的干扰并改善患者体验。我们的研究强调需要确保在大流行规划中考虑员工的应变能力以及保护和支持HCP的战略,准备和管理。
    BACKGROUND: The COVID-19 pandemic resulted in extreme strain on health systems including the health workforce, essential health services and vaccination coverage. We examined disruptions to immunisation and maternal and child health (MCH) services, concerns of personal well-being and delivery of healthcare during the pandemic as well as factors associated with self-reported trauma or burnout among healthcare providers (HCPs).
    METHODS: In March-April 2022, we conducted a cross-sectional survey among HCPs in two provinces of Indonesia. HCPs involved in COVID-19 or routine immunisation and MCH services were randomly selected from district/city health office registration lists. We descriptively analysed service disruptions experienced by HCPs as well as trauma, burnout and concerns of personal well-being and delivery of healthcare during the pandemic. Multivariate logistic regression analyses were undertaken to identify factors associated with trauma or burnout.
    RESULTS: We recruited 604 HCPs. Mobilisation of staff from routine health services to COVID-19 response duties was a key reason for service disruptions (87.9%). Strategies such as community outreach and task shifting were implemented to overcome disruptions. Trauma or burnout during the pandemic was reported by 64.1% HCPs, with 23.5% reporting worse mental or emotional health.Factors associated with trauma or burnout included delivery of COVID-19 immunisation (adjusted OR (aOR) 2.54, 95% CI 1.08 to 5.94); and delivery of both COVID-19 immunisation and routine immunisation compared with no involvement in vaccination programmes (aOR 2.42, 95% CI 1.06 to 5.52); poor treatment in the workplace (aOR 2.26, 95% CI 1.51 to 3.38) and lower confidence to respond to patient queries on COVID-19 immunisation (aOR 1.51, 95% CI 1.03 to 2.22).
    CONCLUSIONS: HCPs experienced service disruptions, trauma and burnout and implemented strategies to minimise disruptions to service delivery and improve patient experiences. Our study highlights the need to ensure that workforce resilience and strategies to protect and support HCPs are considered for pandemic planning, preparedness and management.
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  • 文章类型: Journal Article
    疫苗法律和政策专家反思了政治影响公共卫生决策的危险。
    A vaccine law and policy expert reflects on the dangers of the influence of politics on public health decision making.
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  • 文章类型: Journal Article
    保护新生儿免受侵袭性无乳链球菌感染的母体疫苗是不断发展的医学需求。该疫苗应在妊娠晚期提供,并诱导强烈的免疫反应和保护性抗体的胎盘转移。针对与蛋白质载体缀合的无乳链球菌的多糖疫苗处于开发的晚期阶段。此外,基于蛋白质的疫苗也在开发中,显示出巨大的希望,因为它们可以提供保护,无论血清型。此外,关于新疫苗的安全问题是确定的主要障碍。这里,我们介绍了正在开发的疫苗,并确定了安全性,成本,和功效问题,特别是在高需求的情况下,低收入国家。
    A maternal vaccine to protect newborns against invasive Streptococcus agalactiae infection is a developing medical need. The vaccine should be offered during the third trimester of pregnancy and induce strong immune responses and placental transfer of protective antibodies. Polysaccharide vaccines against S. agalactiae conjugated to protein carriers are in advanced stages of development. Additionally, protein-based vaccines are also in development, showing great promise as they can provide protection regardless of serotype. Furthermore, safety concerns regarding a new vaccine are the main barriers identified. Here, we present vaccines in development and identified safety, cost, and efficacy concerns, especially in high-need, low-income countries.
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