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创新疫苗的上市前开发时间——新冠病毒病 2019(COVID-19)疫苗是例外吗?

Premarket Development Times for Innovative Vaccines--To What Extent Are the Coronavirus Disease 2019 (COVID-19) Vaccines Outliers?

机构信息

Department of Community Health Sciences, Cumming School of Medicine and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Clin Infect Dis. 2022 Jan 29;74(2):347-351. doi: 10.1093/cid/ciab389.

DOI:10.1093/cid/ciab389
PMID:33914860
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8135646/
Abstract

One reason expressed in surveys of people reporting coronavirus disease 2019 (COVID-19) vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously established methods for estimating medical product development times, using the key associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found key patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. By this metric, the development timelines for innovative vaccines have been shortening since the 1980s, and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly used drugs.

摘要

人们在报告 2019 年冠状病毒病(COVID-19)疫苗犹豫的调查中表达的一个原因是这些疫苗是如何迅速推向市场的。为了估计 COVID-19 疫苗的研发时间与其他新型疫苗相比的长短,我们应用了先前为估计医疗产品开发时间而建立的方法,使用制造商引用的关键相关专利申请作为商业开发活动开始的标志。将这些方法应用于最近批准的一批创新疫苗,并将其与第一个批准的 COVID-19 疫苗(BioNTech/Pfizer)进行比较,我们发现该 COVID-19 疫苗的技术关键专利申请在监管批准前 10.0 年就已经提交。按照这一衡量标准,自 20 世纪 80 年代以来,创新疫苗的开发时间线一直在缩短,而 COVID-19 疫苗则轻松符合这一模式。疫苗开发时间线现在甚至与许多最常用的药物相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5f1/8800174/1ba26f4d6517/ciab389f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5f1/8800174/1ba26f4d6517/ciab389f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5f1/8800174/1ba26f4d6517/ciab389f0001.jpg

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