新冠疫苗研發技術回顧

Overview of COVID-19 Vaccine Development

黃立中(Li-Chung Huang)；曾詩雁(Shih-Yen Tseng)；湯念湖(Ni-Hu Tang)；黃敏偉(Min‐Wei Huang)；李世強(Shi-Cheng Lee)

新冠肺炎 ； 新冠疫苗 ； SARS-CoV-2 ； COVID-19 ； Coronavirus vaccine

醫學與健康期刊

11卷1期（2022 / 03 / 01）

71 - 80

繁體中文

全球目前仍處於新型冠狀病毒（COVID-19）的流行期間。世界各國透過持續追蹤調查病毒流行情形，提供與疫情相關之指引與各式防疫措施，分發重要醫療用品等方式來共同應對疫情，並競相開發安全且有效的疫苗。目前已知有數家藥廠成功開發出疫苗，可以預防人們因感染新型冠狀病毒而導致重症或死亡，例如：阿斯特捷利康（AstraZeneca）、嬌生（Johnson & Johnson）、莫德納（Moderna）與輝瑞（Pfizer-BioNTech）。這些世界衛生組織（WHO）認可的疫苗在緊急使用授權協議下可使用於臨床。更重要的是，臺灣高端生物製劑公司於2021年宣布MVC-COV1901疫苗可用於預防新型冠狀病毒，且該疫苗已獲得臺灣第1張緊急使用授權。因此，本研究旨在討論不同疫苗彼此之間研究和設計技術的差異。本研究另外討論的面相是有關於美國和臺灣，對緊急使用授權藥物開發及使用的監管差異，以及一般藥品上市之規定。本篇文章的討論能為醫生或醫療專業人員（如藥師、護理師或醫療技術人員）提供新冠疫苗技術剖析與深入的臨床建議。

The world is still during a Corona virus disease 2019 (COVID-19) pandemic. As world health organization (WHO) and countries around the world to work together on the response by tracking the pandemic, advising on critical interventions, distributing vital medical supplies to those in need, they are racing to develop and deploy safe and effective vaccines. However, several pharmaceutical companies have developed successfully the safe and effective vaccines that prevent people from getting seriously ill or dying from COVID-19, such as AstraZeneca, Johnson & Johnson, Moderna and Pfizer-BioNTech. All these world regulatory organization recognized vaccines were under the agreement to use by the emergency use authorization (EUA). More importantly, Taiwan biotech company Medigen Vaccine Biologic corp. also announced their MVC-COV1901 for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which permitted by Taiwan 1st EUA authorization this year. Thus, our study aims to discuss about the deference between the different vaccines according to the of their research and design (R&D) technologies. Another issue we address is about the regulation of drug development and usage of EUA between Unite Sates and Taiwan. The results of our argument might provide the insight of technologies of COVID-19 vaccine and information for medical practitioner or people who are medical professional, such as pharmacist, registered nurse or medical technologist.

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