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哈佛肯尼迪学院-政策制定者技术资料:疫苗平台(英)

# 政策制定者 # 技术资料 # 疫苗 大小:0.72M | 页数:17 | 上架时间:2021-02-24 | 语言:英文

哈佛肯尼迪学院-政策制定者技术资料:疫苗平台(英).pdf

哈佛肯尼迪学院-政策制定者技术资料:疫苗平台(英).pdf

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类型: 专题

上传者: FF

撰写机构: 哈佛肯尼迪学院

出版日期: 2020-12-30

摘要:

A vaccine platform is a “plug -and-play” physical framework that can be used when developing vaccines for emerging infectious diseases, such as COVID-19. Vaccine platforms use a base carrier or “vehicle,” such as a nucleic acid, viral vector, or liposome, which can be used interchangeably for various diseases. Once designed and licensed for one vaccine, the development of future vaccines using the same platform would simply require substituting the desired antigenic component, or a genetic compound that normal-ly triggers an immune response. This would enable faster and cheaper development, regulatory approval and mass production.12 Terms such as plug-and-play and cartridges are often used to describe the func-tionality of vaccine platform technology.

The development of vaccine platform technologies presents both risks and opportunities. These tech-nologies have the potential to aid in developing vaccines for a variety of existing and emerging diseases. In addition, traditional vaccine development often takes years or even decades, but the versatility and sustainability of platform technologies may allow this process to be substantially streamlined. If suc-cessful, this could facilitate pandemic responses and help to mitigate widespread losses like those seen in the recent COVID-19 pandemic. However, there are concerns about the potential for unknown and dangerous side effects associated with platform technologies. In addition, the funneling of resources and funding into novel vaccine platforms could compete with and decrease access to traditional vaccines that remain vital for the prevention and treatment of disease.

In the United States, there is no legislation specific to vaccine platforms, but a variety of federal laws relating broadly to vaccines and other biological products are applicable. In addition, the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA), which are responsible for vaccine market approval for humans and animals, respectively, have various guidelines that refer, at least in part, to platform technologies. The World Health Organization (WHO) also has various guidelines for all of its member countries that deal with the research, manufacturing, and regulation of vaccines, including some that are specific to products using platform technologies. 

Given the rapidly evolving innovation associated with vaccine development, particularly in response to pandemic situations like COVID-19, there is a need for policymakers to understand the potential risks and benefits of platform technologies. 

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