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[Not Available].[无可用内容]。
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Early Estimates of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Attributable to Co-Circulating Omicron Variants Among Immunocompetent Adults - Increasing Community Access to Testing Program, United States, September 2023-January 2024.2023-2024 年(单价 XBB.1.5)更新 COVID-19 疫苗对免疫功能正常成年人中共同流行的奥密克戎变异株引起的有症状 SARS-CoV-2 感染的有效性的早期估计——增加社区获得检测计划,美国,2023 年 9 月至 2024 年 1 月。
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Vaccines (Basel). 2024 Dec 20;12(12):1436. doi: 10.3390/vaccines12121436.

本文引用的文献

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The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report.真实世界证据在加速疫苗部署的监管和公共卫生决策中的作用——会议报告。
Biologicals. 2024 Feb;85:101750. doi: 10.1016/j.biologicals.2024.101750. Epub 2024 Feb 15.
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Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses.新型流感疫苗:从研发挑战到监管应对
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Algorithm for optimized mRNA design improves stability and immunogenicity.优化 mRNA 设计的算法可提高稳定性和免疫原性。
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COVID's future: mini-waves rather than seasonal surges.新冠疫情的未来:是小规模浪潮而非季节性激增。
Nature. 2023 May;617(7960):229-230. doi: 10.1038/d41586-023-01437-8.
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A recombinant spike-XBB.1.5 protein vaccine induces broad-spectrum immune responses against XBB.1.5-included Omicron variants of SARS-CoV-2.一种重组刺突-XBB.1.5蛋白疫苗可诱导针对包括XBB.1.5在内的SARS-CoV-2奥密克戎变体的广谱免疫反应。
MedComm (2020). 2023 Apr 26;4(3):e263. doi: 10.1002/mco2.263. eCollection 2023 Jun.
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Are repeat COVID infections dangerous? What the science says.重复感染新冠病毒危险吗?科学是这么说的。
Nature. 2023 Apr;616(7958):650-652. doi: 10.1038/d41586-023-01371-9.
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Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China.关于药物监管科学推动中国新冠疫苗研发的综述
Engineering (Beijing). 2022 Mar;10:127-132. doi: 10.1016/j.eng.2022.01.001. Epub 2022 Jan 21.
8
Evidence for antibody as a protective correlate for COVID-19 vaccines.针对 COVID-19 疫苗,抗体作为一种保护相关因素的证据。
Vaccine. 2021 Jul 22;39(32):4423-4428. doi: 10.1016/j.vaccine.2021.05.063. Epub 2021 May 24.
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The first Chinese national standards for SARS-CoV-2 neutralizing antibody.中国首个 SARS-CoV-2 中和抗体的国家标准。
Vaccine. 2021 Jun 23;39(28):3724-3730. doi: 10.1016/j.vaccine.2021.05.047. Epub 2021 May 19.
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Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection.中和抗体水平高度预测对有症状的 SARS-CoV-2 感染的免疫保护作用。
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[无可用内容]。

[Not Available].

作者信息

Xu Li, Li Min, He Wu

机构信息

Center for Drug Evaluation National Medical Products Administration Beijing China.

出版信息

MedComm (2020). 2024 Jul 5;5(7):e646. doi: 10.1002/mco2.646. eCollection 2024 Jul.

DOI:10.1002/mco2.646
PMID:38974715
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11224961/
Abstract

Nowadays, although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic has been handled with long-term management globally, the virus strains keep continuous evolution in an uncertain direction. The newly emerged JN.1 dominated the globally circulating variants in a short time and resulted in increasing hospitalizations. Up to 2024, variant vaccines with the composition of XBB sub-lineage were available due to the coordinated efforts of developers and regulatory agencies. The development of updated vaccines is still needed and the regular availability of coronavirus disease 2019 (COVID-19) vaccines should be timely guaranteed. The current landscape of COVID-19 vaccines and the strategies for accelerating vaccine development and approval are reviewed. Proposals to enhance variants monitoring and the establishment of the strain recommendation mechanism are made. This review provides suggestions about platform technology designation and application, real-world data leveraging and modification to regulatory pathways both for the post-pandemic era of SARS-CoV-2 and for the future unknown pathogen pandemic.

摘要

如今,尽管全球已通过长期管理应对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)疫情,但病毒株仍在朝着不确定的方向持续进化。新出现的JN.1在短时间内成为全球传播的主要变异株,并导致住院人数增加。截至2024年,由于研发人员和监管机构的共同努力,已出现了含XBB亚谱系成分的变异株疫苗。仍需要研发更新的疫苗,应及时确保2019冠状病毒病(COVID-19)疫苗的常规供应。本文综述了COVID-19疫苗的现状以及加速疫苗研发和审批的策略。提出了加强变异株监测和建立毒株推荐机制的建议。本综述针对SARS-CoV-2大流行后的时代以及未来未知病原体大流行,就平台技术的设计与应用、利用真实世界数据以及调整监管途径提供了建议。