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The early safety profile of simultaneous vaccination against influenza and Respiratory Syncytial Virus (RSV) in patients with high-risk heart failure. 高危心力衰竭患者同时接种流感和呼吸道合胞病毒 (RSV) 疫苗的早期安全性概况。
Pub Date : 2024-03-25 DOI: 10.1016/j.vaccine.2024.03.060
Jan Biegus, Leszek Szenborn, Robert Zymliński, Michał Zakliczyński, Krzysztof Reczuch, Mateusz Guzik, Szymon Urban, Marta Rosiek-Biegus, Berenika Jankowiak, Gracjan Iwanek, Marat Fudim, Piotr Ponikowski

The safety of simultaneous vaccination for Respiratory Syncytial Virus (RSV) and influenza in vulnerable high-risk heart failure (HF) patients remains unclear. In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September 15th to November 17th, 2023. Adverse events were collected on the fourth-day post-vaccination. Overall, the vaccination was well tolerated, with the most common reaction being injection site pain (63 %). General symptoms occurred in 33 % of patients, predominantly fatigue (23 %), myalgia (12 %), and headache (9 %). Grade 3 reactions were observed in 6 % of patients, and a few experienced temperature elevation or flu-like symptoms, managing them with antipyretics. Notably, there were no exacerbations of HF, hospitalizations, or deaths within a week post-vaccination. This study indicates the safety of simultaneous influenza and RSV vaccination in high-risk HF patients, with a low incidence of mild adverse events.

在易感的高危心衰(HF)患者中同时接种呼吸道合胞病毒(RSV)和流感疫苗的安全性仍不明确。在一项开放标签前瞻性研究中,105 名患者在 2023 年 9 月 15 日至 11 月 17 日期间同时接种了流感疫苗(Vaxigrip Tetra,2023/2024 季,赛诺菲)和 RSV 疫苗(Arexvy,葛兰素史克)。不良反应在接种后第四天收集。总体而言,接种效果良好,最常见的反应是注射部位疼痛(63%)。33%的患者出现全身症状,主要是疲劳(23%)、肌痛(12%)和头痛(9%)。6%的患者出现三级反应,少数患者出现体温升高或类似流感的症状,需要服用退烧药。值得注意的是,接种疫苗后一周内没有出现高血压加重、住院或死亡病例。这项研究表明,在高危高血压患者中同时接种流感和 RSV 疫苗是安全的,轻微不良反应的发生率很低。
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引用次数: 0
Global VAX: A U.S. contribution to global COVID-19 vaccination efforts, 2021-2023. 全球 VAX:2021-2023 年美国对全球 COVID-19 疫苗接种工作的贡献。
Pub Date : 2024-03-23 DOI: 10.1016/j.vaccine.2024.03.054
Benjamin A Dahl, Beth Tritter, Deena Butryn, Melissa Dahlke, Sean Browning, Richard Gelting, Monica Fleming, Nancy Ortiz, Jacqueline Labrador, Ryan Novak, David Fitter, Elizabeth Bell, Megan McGuire, Robert Rosenbaum, Robert Pulwer, Jolene Wun, Anna McCaffrey, Maisoon Chowdhury, Nida Parks, Marc Cunningham, Anthony Mounts, Dora Curry, Dominique Richardson, Gavin Grant

In December 2021 the U.S. Government announced a new, whole-of-government $1.8 billion effort, the Initiative for Global Vaccine Access (Global VAX) in response to the global COVID-19 pandemic. Using the foundation of decades of U.S. government investments in global health and working in close partnership with local governments and key global and multilateral organizations, Global VAX enabled the rapid acceleration of the global COVID-19 vaccine rollout in selected countries, contributing to increased COVID-19 vaccine coverage in some of the world's most vulnerable communities. Through Global VAX, the U.S. Government has supported 125 countries to scale up COVID-19 vaccine delivery and administration while strengthening primary health care systems to respond to future health crises. The progress made by Global VAX has paved the way for a stronger global recovery and improved global health security.

2021 年 12 月,美国政府宣布了一项耗资 18 亿美元的全新政府整体行动--全球疫苗普及行动(Global VAX),以应对全球 COVID-19 大流行。利用美国政府数十年来在全球健康领域的投资基础,并与当地政府及主要全球和多边组织密切合作,全球 VAX 在选定的国家迅速加快了 COVID-19 疫苗的全球推广,从而提高了 COVID-19 疫苗在世界上一些最脆弱社区的覆盖率。通过全球 VAX,美国政府支持 125 个国家扩大了 COVID-19 疫苗的交付和管理,同时加强了初级卫生保健系统,以应对未来的卫生危机。全球 VAX 计划所取得的进展为全球更强劲的复苏和更好的全球健康安全铺平了道路。
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引用次数: 0
Is vaccination against measles, mumps, and rubella associated with reduced rates of antibiotic treatments among children below the age of 2 years? Nationwide register-based study from Denmark, Finland, Norway, and Sweden. 接种麻疹、腮腺炎和风疹疫苗是否会降低 2 岁以下儿童的抗生素治疗率?来自丹麦、芬兰、挪威和瑞典的全国性登记研究。
Pub Date : 2024-03-19 DOI: 10.1016/j.vaccine.2024.03.026
Lise Gehrt, Hélène Englund, Ida Laake, Heta Nieminen, Sören Möller, Berit Feiring, Mika Lahdenkari, Lill Trogstad, Christine Stabell Benn, Signe Sørup

Objectives: Previous studies have shown that vaccination against measles, mumps, and rubella (MMR) may have beneficial non-specific effects, reducing the risk of infections not targeted by the vaccine. We investigated if MMR vaccine given after the third dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP3), was associated with reduced rates of antibiotic treatments.

Methods: Register-based cohort study following children from the age of recommended MMR vaccination until age 2 years. We included 831,287 children born in Denmark, Finland, Norway, and Sweden who had received DTaP3 but not yet MMR vaccine. Cox proportional hazards regression with age as the underlying timescale and vaccination status as a time-varying exposure was used to estimate covariate-adjusted Hazard Ratios (aHRs) and inverse probability of treatment weighted (IPTW) HRs of antibiotic treatments. Summary estimates were calculated using random-effects meta-analysis.

Results: Compared with only having received DTaP3, receipt of MMR vaccine after DTaP3 was associated with reduced rates of antibiotic treatments in all countries: the aHR was 0.92 (0.91-0.93) in Denmark, 0.92 (0.90-0.94) in Finland, 0.84 (0.82-0.85) in Norway, and 0.87 (0.85-0.90) in Sweden, yielding a summary estimate of 0.89 (0.85-0.93). A stronger beneficial association was seen in a negative control exposure analysis comparing children vaccinated with DTaP3 vs two doses of DTaP.

Conclusions: Across the Nordic countries, receipt of MMR vaccine after DTaP3 was associated with an 11% lower rate of antibiotic treatments. The negative control analysis suggests that the findings are affected by residual confounding. Findings suggest that potential non-specific effects of MMR vaccine are of limited clinical and public health importance for the milder infections treated out-of-hospital in the Nordic setting.

目的:以往的研究表明,接种麻疹、腮腺炎和风疹(MMR)疫苗可能会产生有益的非特异性效果,降低疫苗未针对的感染风险。我们研究了在接种第三剂白喉-破伤风-百日咳疫苗(DTaP3)后接种麻疹、腮腺炎和风疹疫苗是否与降低抗生素治疗率有关:以登记为基础的队列研究,从推荐接种麻风腮疫苗的年龄开始跟踪儿童,直至其 2 岁。我们纳入了 831,287 名出生在丹麦、芬兰、挪威和瑞典、接种过 DTaP3 而未接种过麻风腮疫苗的儿童。我们采用以年龄为基本时间尺度、疫苗接种状况为时变暴露的 Cox 比例危险度回归来估算协变量调整后的危险比 (aHR) 和抗生素治疗的逆治疗加权 (IPTW) 危险比。采用随机效应荟萃分析法计算了汇总估计值:在所有国家,与只接种过 DTaP3 相比,接种 DTaP3 后接种麻腮风疫苗与抗生素治疗率降低有关:丹麦的 aHR 为 0.92(0.91-0.93),芬兰为 0.92(0.90-0.94),挪威为 0.84(0.82-0.85),瑞典为 0.87(0.85-0.90),得出的总估计值为 0.89(0.85-0.93)。在对接种DTaP3与接种两剂DTaP的儿童进行的阴性对照暴露分析中,发现了更强的有益关联:结论:在整个北欧国家,接种DTaP3后接种麻腮风疫苗与抗生素治疗率降低11%有关。阴性对照分析表明,研究结果受到了残余混杂因素的影响。研究结果表明,接种麻腮风疫苗的潜在非特异性效应对北欧院外治疗的轻度感染的临床和公共卫生意义有限。
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引用次数: 0
WITHDRAWN: PIRES2-EGFP/CTB-UreI vaccination activated a mixed Th1/Th2/Th17 immune system defense towards Helicobacter pylori infection in the BALB/c mice model. 在 BALB/c 小鼠模型中,接种 PIRES2-EGFP/CTB-UreI 疫苗可激活 Th1/Th2/Th17 混合免疫系统防御幽门螺旋杆菌感染。
Pub Date : 2024-03-07 DOI: 10.1016/j.vaccine.2024.02.050
Sana Ghasemifar, Omid Chabak, Tohid Piri-Gharaghie, Abbas Doosti

This article has been withdrawn at the request of the Editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal. The data presented in the manuscript was deemed severely flawed after appearing online as an Article in Press. The scientific community raised concerns about the methodology (including but not limited to major technical issues) used in the study and the subsequent conclusions drawn from the presented experiments. After careful investigation, the Vaccine editorial office concluded that the data in the publication was indeed severely flawed and that the concerns raised by the scientific community were valid. Therefore, the journal editors decided to withdraw the article and sincerely apologize for any inconvenience caused.

人类胃炎、胃溃疡、远端胃癌和胃黏膜淋巴瘤的发生与幽门螺旋杆菌(H. pylori)密切相关。由于抗生素耐药性日益普遍,接种疫苗是一种有效的预防措施。融合疫苗接种是一种潜在的实用方法。本研究将霍乱毒素 B 亚基(CTB)与抗原性幽门螺杆菌尿素酶 I 亚基(CTB-UreI)结合,制成了一种融合疫苗。CTB-UreI DNA疫苗被化学克隆到pIRES2-EGFP中,并通过PCR和限制性酶消化验证了克隆的成功。对 CTB-UreI 在大肠杆菌 BL21(DE3) 中的诱导进行了研究。在 BALB/c 小鼠中评估了疫苗的免疫原性和免疫保护效力。Western 印迹检测成功确定了 CTB-UreI 的活化。相比之下,接种 pIRES2-EGFP/CTB-UreI 疫苗的 BALB/c 小鼠血液样本中的 IgG、IgA、IFN-γ、IL-4 和 IL-17 水平更高。此外,胃损伤和细菌负荷也有所减少。此外,接种了 pIRES2-EGFP/CTB-UreI 的 BALB/c 小鼠对幽门螺杆菌的挑战表现出了高水平的免疫力(100%)。pIRES2-EGFP/CTB-UreI引起了Th1/Th2/Th17组合免疫反应,可能有助于形成有效的防御机制。我们的数据表明,使用这种融合疫苗预防幽门螺杆菌感染是一种很有前景的选择。
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引用次数: 0
An overview of the COVID-19 pediatric vaccine program - The U.S. experience vaccinating children ages 6 months through 17 years. COVID-19 儿童疫苗计划概述 - 美国为 6 个月至 17 岁儿童接种疫苗的经验。
Pub Date : 2024-02-29 DOI: 10.1016/j.vaccine.2024.02.019
Kevin Chatham-Stephens, Rosalind J Carter, Chris Duggar, Kate R Woodworth, Catherine Amanda Carnes, Achal Bhatt, Christina Ottis, Chris Voegeli, Shannon Stokley, Tara Vogt

COVID-19 vaccination decreases risk for COVID-19 illness and severe disease in children, including multisystem inflammatory syndrome (MIS-C) and death. On December 13, 2020, CDC recommended COVID-19 vaccination for persons ages ≥16 years, with expansion on May 12, 2021, to adolescents ages 12-15 years; to children ages 5-11 years on November 2, 2021; and to children ages 6 months-4 years on June 18, 2022. Following each age-specific recommendation, the U.S. government collaborated with state and local governments, vaccine manufacturers, and numerous other public and private entities, to ensure rapid, broad, and equitable COVID-19 vaccine distribution to strategic locations across the country to maximize access. However, vaccination coverage among children has been lower than among adults and lower among younger children than adolescents. As of May 10, 2023, COVID-19 primary series vaccination coverage was 61.8% among U.S. children ages 12-17 years, 32.9% among those ages 5-11 years, and 5.5% among those ages 6 months-4 years. This manuscript describes the planning and implementation of the U.S. COVID-19 pediatric vaccine program, including successes (e.g., the availability of pharmacy vaccination to extend access beyond more traditional pediatric vaccine providers) and challenges (e.g., multi-dose vaccine vials instead of single-dose vials, leading to concerns about wastage) to provide a historical record of the program and to help inform planning and implementation of future routine or pandemic-related pediatric vaccination campaigns.

接种 COVID-19 疫苗可降低儿童患 COVID-19 疾病和严重疾病的风险,包括多系统炎症综合征 (MIS-C) 和死亡。2020 年 12 月 13 日,美国疾病预防控制中心建议年龄≥16 岁者接种 COVID-19 疫苗,2021 年 5 月 12 日扩大到 12-15 岁青少年;2021 年 11 月 2 日扩大到 5-11 岁儿童;2022 年 6 月 18 日扩大到 6 个月至 4 岁儿童。根据每个特定年龄段的建议,美国政府与各州和地方政府、疫苗生产商以及众多其他公共和私营实体合作,确保 COVID-19 疫苗快速、广泛、公平地分发到全国各地的战略要地,以最大限度地提高接种率。然而,儿童的疫苗接种率一直低于成人,低龄儿童的接种率也低于青少年。截至 2023 年 5 月 10 日,美国 12-17 岁儿童的 COVID-19 主要系列疫苗接种率为 61.8%,5-11 岁儿童为 32.9%,6 个月-4 岁儿童为 5.5%。本手稿介绍了美国 COVID-19 儿科疫苗计划的规划和实施情况,包括成功之处(如提供药房接种,将接种范围扩大到传统儿科疫苗提供者之外)和挑战(如多剂量疫苗瓶代替单剂量疫苗瓶,导致浪费问题),以提供该计划的历史记录,并为未来常规或大流行相关儿科疫苗接种活动的规划和实施提供参考。
{"title":"An overview of the COVID-19 pediatric vaccine program - The U.S. experience vaccinating children ages 6 months through 17 years.","authors":"Kevin Chatham-Stephens, Rosalind J Carter, Chris Duggar, Kate R Woodworth, Catherine Amanda Carnes, Achal Bhatt, Christina Ottis, Chris Voegeli, Shannon Stokley, Tara Vogt","doi":"10.1016/j.vaccine.2024.02.019","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.02.019","url":null,"abstract":"<p><p>COVID-19 vaccination decreases risk for COVID-19 illness and severe disease in children, including multisystem inflammatory syndrome (MIS-C) and death. On December 13, 2020, CDC recommended COVID-19 vaccination for persons ages ≥16 years, with expansion on May 12, 2021, to adolescents ages 12-15 years; to children ages 5-11 years on November 2, 2021; and to children ages 6 months-4 years on June 18, 2022. Following each age-specific recommendation, the U.S. government collaborated with state and local governments, vaccine manufacturers, and numerous other public and private entities, to ensure rapid, broad, and equitable COVID-19 vaccine distribution to strategic locations across the country to maximize access. However, vaccination coverage among children has been lower than among adults and lower among younger children than adolescents. As of May 10, 2023, COVID-19 primary series vaccination coverage was 61.8% among U.S. children ages 12-17 years, 32.9% among those ages 5-11 years, and 5.5% among those ages 6 months-4 years. This manuscript describes the planning and implementation of the U.S. COVID-19 pediatric vaccine program, including successes (e.g., the availability of pharmacy vaccination to extend access beyond more traditional pediatric vaccine providers) and challenges (e.g., multi-dose vaccine vials instead of single-dose vials, leading to concerns about wastage) to provide a historical record of the program and to help inform planning and implementation of future routine or pandemic-related pediatric vaccination campaigns.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140013887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Planning for the future of maternal immunization: Building on lessons learned from the COVID-19 pandemic. 规划孕产妇免疫接种的未来:从 COVID-19 大流行中吸取经验教训。
Pub Date : 2024-02-28 DOI: 10.1016/j.vaccine.2024.01.069
Dana Meaney-Delman, Sarah Carroll, Kara Polen, Tara C Jatlaoui, Sarah Meyer, Sara Oliver, Julianne Gee, Tom Shimabukuro, Hilda Razzaghi, Laura Riley, Romeo R Galang, Van Tong, Suzanne Gilboa, Sascha Ellington, Amanda Cohn

As the worldwide COVID-19 pandemic unfolded, the clinical and public health community raced to understand SARS-CoV-2 infection and develop life-saving vaccines. Pregnant persons were disproportionately impacted, experiencing more severe illness and adverse pregnancy outcomes. And yet, when COVID-19 vaccines became available in late 2020, safety and efficacy data were not available to inform their use during pregnancy because pregnant persons were excluded from pre-authorization clinical trials. Concerns about vaccine safety during pregnancy and misinformation linking vaccination and infertility circulated widely, creating a lack of vaccine confidence. Many pregnant people initially chose not to get vaccinated, and while vaccination rates rose after safety and effectiveness data became available, COVID-19 vaccine acceptance was suboptimal and varied across racial and ethnic distribution of the pregnant population. The COVID-19 pandemic experience provided valuable insights that can inform current and future approaches to maternal vaccination against.

随着 COVID-19 在全球范围内的大流行,临床和公共卫生界急需了解 SARS-CoV-2 感染并开发救命疫苗。孕妇受到的影响尤为严重,她们经历了更严重的疾病和不良妊娠结局。然而,当 COVID-19 疫苗于 2020 年末上市时,由于孕妇被排除在授权前临床试验之外,因此没有安全和有效性数据来指导孕期使用。对孕期疫苗安全性的担忧以及将接种疫苗与不孕症联系起来的错误信息广为流传,导致人们对疫苗缺乏信心。许多孕妇起初选择不接种疫苗,虽然在获得安全性和有效性数据后接种率有所上升,但 COVID-19 疫苗的接受度并不理想,而且不同种族和民族的孕妇接种率也不尽相同。COVID-19 大流行的经验提供了宝贵的启示,可为当前和未来的孕产妇疫苗接种方法提供参考。
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引用次数: 0
U.S. COVID-19 vaccine distribution strategies, systems, performance, and lessons learned, December 2020 - May 2023. 2020 年 12 月至 2023 年 5 月,美国 COVID-19 疫苗分发战略、系统、绩效和经验教训。
Pub Date : 2024-02-14 DOI: 10.1016/j.vaccine.2024.02.020
Christopher Duggar, Jeanne M Santoli, Cameron Noblit, Lori B Moore, Roua El Kalach, Carolyn B Bridges

During December 2020 through May 2023, the Centers for Disease Control and Prevention's (CDC) Immunization Services Division supported and executed the largest vaccine distribution effort in U.S. history, delivering nearly one billion doses of COVID-19 vaccine to vaccine providers in all 50 states, District of Columbia, Puerto Rico, Virgin Islands, Guam, Federated States of Micronesia, American Samoa, Marshall Islands, Northern Mariana Islands, and Palau. While existing infrastructure, ordering, and distribution mechanisms were in place from the Vaccines for Children Program (VFC) and experience had been gained during the 2009 H1N1 pandemic and incorporated into influenza vaccination pandemic planning, the scale and complexity of the national mobilization against a novel coronavirus resulted in many previously unforeseen challenges, particularly related to transporting and storing the majority of the U.S. COVID-19 vaccine at frozen and ultra-cold temperatures. This article describes the infrastructure supporting the distribution of U.S. government-purchased COVID-19 vaccines that was in place pre-pandemic, and the infrastructure, processes, and communications efforts developed to support the heightened demands of the COVID-19 vaccination program, and describes lessons learned.

2020 年 12 月至 2023 年 5 月期间,美国疾病控制和预防中心 (CDC) 免疫接种服务部支持并执行了美国历史上最大的疫苗分发工作,向所有 50 个州、哥伦比亚特区、波多黎各、维尔京群岛、关岛、密克罗尼西亚联邦、美属萨摩亚、马绍尔群岛、北马里亚纳群岛和帕劳的疫苗提供者提供了近 10 亿剂 COVID-19 疫苗。尽管儿童疫苗计划 (VFC) 现有的基础设施、订购和分发机制已经到位,并且在 2009 年 H1N1 流感大流行期间获得了经验并将其纳入了流感疫苗接种大流行规划,但针对新型冠状病毒的全国性动员的规模和复杂性带来了许多以前未曾预见的挑战,特别是与在冷冻和超低温条件下运输和储存美国 COVID-19 疫苗的大部分相关的挑战。本文介绍了支持分发美国政府购买的 COVID-19 疫苗的基础设施,这些基础设施在疫情发生前就已到位,以及为支持 COVID-19 疫苗接种计划的更高需求而开发的基础设施、流程和沟通工作,并介绍了所吸取的经验教训。
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引用次数: 0
Minimal interval for the administration of a pneumococcal polysaccharide vaccine following the administration of a pneumococcal conjugate vaccine. 接种肺炎球菌结合疫苗后接种肺炎球菌多糖疫苗的最短间隔时间。
Pub Date : 2024-02-12 DOI: 10.1016/j.vaccine.2024.02.023
Philippe De Wals, Michaël Desjardins
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引用次数: 0
COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic. COVID-19 疫苗安全技术 (VaST) 工作组:加强大流行期间的疫苗安全监测。
Pub Date : 2024-02-09 DOI: 10.1016/j.vaccine.2023.12.059
Lauri E Markowitz, Robert H Hopkins, Karen R Broder, Grace M Lee, Kathryn M Edwards, Matthew F Daley, Lisa A Jackson, Jennifer C Nelson, Laura E Riley, Veronica V McNally, Robert Schechter, Patricia N Whitley-Williams, Francesca Cunningham, Matthew Clark, Margaret Ryan, Karen M Farizo, Hui-Lee Wong, Jeffery Kelman, Tatiana Beresnev, Valerie Marshall, David K Shay, Julianne Gee, Jared Woo, Michael M McNeil, John R Su, Tom T Shimabukuro, Melinda Wharton, H Keipp Talbot

During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.

在 COVID-19 大流行期间,美国正以前所未有的加速度开发 COVID-19 候选疫苗。预计一旦获得美国食品药品管理局 (FDA) 的紧急使用授权 (EUA) 或 FDA 批准,COVID-19 疫苗将被广泛使用,并可能在短时间内接种到数百万人身上。为及时发现和评估潜在的安全问题,有必要在紧急使用授权/许可后阶段进行强化监测。为此,美国疾病控制和预防中心 (CDC) 召集了一个免疫实践咨询委员会 (ACIP) 工作组,专门负责 COVID-19 疫苗的安全性,该工作组由独立的疫苗安全专家和联邦机构的代表组成,即 ACIP COVID-19 疫苗安全技术工作组 (VaST)。本报告概述了 VaST 的组织和活动,总结了作为 COVID-19 疫苗大流行期间疫苗安全监控综合工作一部分而审查的数据,并重点介绍了 CDC、ACIP 和 FDA 针对不断积累的授权后安全数据而采取的部分行动。在 2020 年 11 月至 2023 年 4 月的 29 个月期间,VaST 召开了定期会议;至 2023 年 3 月,FDA 为四家不同生产商的六种 COVID-19 疫苗签发了 EUA,并随后为其中两种 COVID-19 疫苗颁发了许可证。独立疫苗安全专家与联邦机构合作,确保在此期间及时评估疫苗安全数据。VaST 与 ACIP COVID-19 疫苗工作组密切合作;该工作组利用安全数据和 VaST 的评估结果进行效益-风险评估,并为 COVID-19 疫苗接种政策提供指导。VaST 审查的安全主题包括安全监测系统中确定的主题以及其他科学或公众关注的主题。VaST 为疾病预防控制中心的 COVID-19 疫苗安全性监测工作提供指导,为来自美国政府多个疫苗安全系统的数据审查提供论坛,并确保联邦政府以外的科学家和临床医生等不同群体能够及时审查疫苗安全性数据。在未来发生大流行病或其他生物性公共卫生紧急事件时,VaST 模式可用于加强疫苗安全监控,提高公众信心,并通过将独立的非政府安全专家纳入监测过程以及联邦和其他合作伙伴之间的紧密合作来增加透明度。
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引用次数: 0
The U.S. COVID-19 vaccination program: A look back and future directions. 美国 COVID-19 疫苗接种计划:回顾过去,展望未来。
Pub Date : 2024-01-26 DOI: 10.1016/j.vaccine.2024.01.053
Elisha Hall, Barbara E Mahon, Georgina Peacock
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引用次数: 0
期刊
Vaccine
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