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降低疫苗研发风险:经验教训、挑战与前景。

De-risking vaccine development: lessons, challenges, and prospects.

作者信息

Masignani Vega, Palacios Ricardo, Martin Marie-Thérèse, Tibaldi Fabian, Vadivelu V Kumaran

机构信息

GSK, Siena, Italy.

CARB-X, Boston University School of Law, Boston, MA, USA.

出版信息

NPJ Vaccines. 2025 Jul 30;10(1):177. doi: 10.1038/s41541-025-01211-z.

DOI:10.1038/s41541-025-01211-z
PMID:40739092
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12310957/
Abstract

Vaccine development is long and costly. Technical, clinical, regulatory, and manufacturing risks throughout the development cycle hampered manufacturers' efforts towards more challenging and financially less rewarding targets, with profound implications for public health. Early de-risking strategies can help closing the vaccine productivity gap and support sustainable access to vaccines. Illustrated by examples of early and efficient decision-making, the herein proposed strategies can ultimately increase the success rates of vaccine programs.

摘要

疫苗研发周期长且成本高昂。整个研发周期中的技术、临床、监管和生产风险阻碍了制造商朝着更具挑战性且经济回报较低的目标努力,对公共卫生产生了深远影响。早期降低风险策略有助于缩小疫苗生产效率差距,并支持疫苗的可持续获取。通过早期高效决策的实例说明,本文提出的策略最终可提高疫苗项目的成功率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/de7fb17bcaf8/41541_2025_1211_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/9f37d93194b3/41541_2025_1211_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/e57e3b886783/41541_2025_1211_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/25afcf7c551f/41541_2025_1211_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/de7fb17bcaf8/41541_2025_1211_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/9f37d93194b3/41541_2025_1211_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/e57e3b886783/41541_2025_1211_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/25afcf7c551f/41541_2025_1211_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8063/12310957/de7fb17bcaf8/41541_2025_1211_Fig4_HTML.jpg

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本文引用的文献

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Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine.评估多组分B群脑膜炎球菌疫苗性能的方法。
mSphere. 2025 Apr 29;10(4):e0089824. doi: 10.1128/msphere.00898-24. Epub 2025 Apr 8.
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A roadmap for fostering timely regulatory and ethics approvals of international clinical trials in support of global health research systems.一份促进国际临床试验及时获得监管和伦理批准以支持全球卫生研究系统的路线图。
Lancet Glob Health. 2025 Apr;13(4):e769-e777. doi: 10.1016/S2214-109X(24)00515-1.
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Controlled Human Infection Studies Accelerate Vaccine Development.
人体感染对照研究加速疫苗研发。
J Infect Dis. 2025 Jun 2;231(5):1112-1116. doi: 10.1093/infdis/jiaf053.
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Multi-Stakeholder Call to Action for the Future of Vaccine Post-Marketing Monitoring: Proceedings from the First Beyond COVID-19 Monitoring Excellence (BeCOME) Conference.疫苗上市后监测未来的多利益相关方行动呼吁:首届超越COVID-19监测卓越(BeCOME)会议纪要
Drug Saf. 2025 May;48(5):577-585. doi: 10.1007/s40264-024-01510-9. Epub 2025 Jan 10.
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Vaccine hesitancy: a structured review from a behavioral perspective (2015-2022).疫苗犹豫:基于行为视角的结构化综述(2015 - 2022年)
Psychol Health Med. 2025 Jan;30(1):119-147. doi: 10.1080/13548506.2024.2417442. Epub 2024 Oct 28.
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Vaccines and monoclonal antibodies to prevent healthcare-associated bacterial infections.疫苗和单克隆抗体预防医源性细菌感染。
Clin Microbiol Rev. 2024 Sep 12;37(3):e0016022. doi: 10.1128/cmr.00160-22. Epub 2024 Aug 9.
7
Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial.AS01E 佐剂呼吸道合胞病毒融合前 F 蛋白疫苗在老年人中接种 1 剂后的免疫原性和安全性:一项 3 期试验。
J Infect Dis. 2024 Jul 25;230(1):e102-e110. doi: 10.1093/infdis/jiad546.
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J Microbiol Methods. 2024 Sep;224:106998. doi: 10.1016/j.mimet.2024.106998. Epub 2024 Jul 15.
9
Immunization agenda 2030: A global strategy to leave no one behind.《2030年免疫议程:不让任何人掉队的全球战略》
Vaccine. 2024 Apr 8;42 Suppl 1:S5-S14. doi: 10.1016/j.vaccine.2022.11.042.
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N Engl J Med. 2024 Jul 11;391(2):102-105. doi: 10.1056/NEJMp2402379. Epub 2024 Jul 6.