Clinical approval of nanotechnology-based SARS-CoV-2 mRNA vaccines: impact on translational nanomedicine.
Clinical approval of nanotechnology-based SARS-CoV-2 mRNA vaccines: impact on translational nanomedicine.
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DOI：
10.1007/s13346-021-00911-y
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发表时间：
2021-08
影响因子：
5.4
通讯作者：
Amiji M
中科院分区：
文献类型：
--
作者：
Milane L;Amiji M
在第一例人类感染 SARS-CoV-2 病例一年后，两种基于纳米药物的 mRNA 疫苗已被快速跟踪、开发出来，并在全球范围内获得了紧急使用授权，继前两种疫苗之后，又有更多疫苗获得批准。几种 SARS-CoV-2 疫苗组合物使用纳米技术配方。 COVID-19 大流行的一线希望是 SARS-CoV-2 疫苗的快速开发推进了纳米医学药物输送系统的临床转化途径。基于脂质的纳米粒子的实验室科学已经准备好并迎接快速疫苗开发的临床挑战。 SARS-CoV-2 纳米药物疫苗的成功开发和快速跟踪对纳米技术支持的药物和基因递送的未来具有令人兴奋的影响；它表明纳米医学对于成功传递核酸等先进分子疗法是必要且关键的，它正在建立四期临床试验的安全性和群体效应的先例，并为更复杂的非脂质纳米药物的临床转化奠定基础。基于 SARS-CoV-2 纳米技术的疫苗的开发、快速跟踪和批准已将纳米药物临床转化中看似艰巨的挑战转变为可以克服的可衡量的障碍。由于应对 COVID-19 大流行所取得的巨大科学成就，某些转化纳米药物已经简化了数年、甚至数十年的时间。
One year after the first human case of SARS-CoV-2, two nanomedicine-based mRNA vaccines have been fast-tracked, developed, and have received emergency use authorization throughout the globe with more vaccine approvals on the heels of these first two. Several SARS-CoV-2 vaccine compositions use nanotechnology-enabled formulations. A silver lining of the COVID-19 pandemic is that the fast-tracked vaccine development for SARS-CoV-2 has advanced the clinical translation pathway for nanomedicine drug delivery systems. The laboratory science of lipid-based nanoparticles was ready and rose to the clinical challenge of rapid vaccine development. The successful development and fast tracking of SARS-CoV-2 nanomedicine vaccines has exciting implications for the future of nanotechnology-enabled drug and gene delivery; it demonstrates that nanomedicine is necessary and critical to the successful delivery of advanced molecular therapeutics such as nucleic acids, it is establishing the precedent of safety and the population effect of phase four clinical trials, and it is laying the foundation for the clinical translation of more complex, non-lipid nanomedicines. The development, fast-tracking, and approval of SARS-CoV-2 nanotechnology-based vaccines has transformed the seemingly daunting challenges for clinically translating nanomedicines into measurable hurdles that can be overcome. Due to the tremendous scientific achievements that have occurred in response to the COVID-19 pandemic, years, perhaps even decades, have been streamlined for certain translational nanomedicines.
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