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超速新冠病毒疫苗研发:生物制药技术和公私合作伙伴关系成熟的受益者。

Warp-Speed Covid-19 Vaccine Development: Beneficiaries of Maturation in Biopharmaceutical Technologies and Public-Private Partnerships.

机构信息

Department of Pharmaceutics and Bioengineering, University of Washington, Seattle, WA 98206-7610, USA.

出版信息

J Pharm Sci. 2021 Feb;110(2):615-618. doi: 10.1016/j.xphs.2020.11.010. Epub 2020 Nov 17.

Abstract

It is anticipated that effective vaccines will enable the resumption of social and economic normalcy. Current calls for masking, social distancing and other restrictive measures for the public-good are difficult to enforce and are unstainable. As ~2-4% of the 50 million SARS-CoV2-infected have succumbed to Covid-19, the US department of Health and Human Services has organized a public-private partnership called Operation Warp Speed (OWS) to develop, produce and deliver 300 million doses of safe and effective vaccines with a January 2021 target. While a majority of the 300+ Covid-19 vaccine candidates are in various stages of preclinical and early-stage clinical testing, 6 clinical candidates are supported with over 10 billion USD plus integrated resources under the OWS agenda. This unprecedented approach is investing in the manufacture of product candidates ahead of product approval. It is enabled by new gene and recombinant pharmaceutical platform technologies that are accelerating the clinical study timeline from ~10 to less than 1 year. It is anticipated that one or more of the 6 candidates under the OWS initiative will be safe, effective and provide a sustained immune response to prevent infection and disease progression. This way, social and economic activities could return to normalcy.

摘要

预计有效的疫苗将使社会和经济恢复正常。目前,公众对口罩、社交距离和其他公共卫生限制措施的呼吁很难执行,而且也不可持续。在美国,有 2-4%的 5000 万例 SARS-CoV2 感染者死于 COVID-19,因此美国卫生与公众服务部组织了公私合作伙伴关系,称为“战速行动”(OWS),以开发、生产和提供 3 亿剂安全有效的疫苗,并将目标定在 2021 年 1 月。虽然 300 多种 COVID-19 疫苗候选者处于临床前和早期临床测试的各个阶段,但在 OWS 议程下,有 6 种临床候选者获得了超过 100 亿美元的资金和综合资源支持。这种前所未有的方法是在产品获得批准之前投资于产品候选者的制造。这得益于新的基因和重组药物平台技术,这些技术将临床研究时间从 10 年缩短到不到 1 年。预计 OWS 计划下的 6 种候选者之一或多种将是安全、有效,并能提供持续的免疫反应,以预防感染和疾病进展。这样,社会和经济活动就可以恢复正常。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99ef/7671640/5452e8a37932/gr1_lrg.jpg

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