新冠候選疫苗之緊急授權：對疫苗臨床試驗的影響【全球瞭望】 試閱
The Granting of Emergency Use Designation to COVID-19 Candidate Vaccines : Implications for COVID-19 Vaccine Trials
疫苗是目前全球領先的研究重點，有些國家表示，如若在疫苗獲得許可之前，就有令人信服的疫苗試用案例，這些國家將準備授權其緊急使用、或是以公共衛生為由，有條件地進行批准。截至2020年12月1日，數間領先開發新冠疫苗的廠商表示已申請或打算申請其疫苗的緊急授權。假如候選疫苗在指定使用範圍內獲得緊急授權，並於第三期試驗結束前有計畫地部署接種，這種策略可能會對新冠疫苗研究和有效控制新冠肺炎的大流行產生深遠的影響，而這些影響值得我們小心斟酌。
An efficacious COVID-19 vaccine is currently the world’s leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COVID-19 candidate vaccines have indicated that they have applied, or intend to apply, for emergency authorisation for their vaccines. Should candidate vaccines attain emergency use designation and be programmatically deployed before their phase 3 trials conclude, such a strategy could have far reaching consequences for COVID-19 vaccine research and the effective control of the COVID-19 pandemic. These issues merit careful consideration.
047-065
