二期臨床試驗解盲
Medigen Vaccine Biologics Corp., a Taiwan-based biopharmaceutical company, said that it has submitted an application to the Ministry of Health and Welfare for Emergency Use Authorization of its COVID-19 vaccine.
台灣生物製藥公司高端表示，已向衛福部提交了COVID-19疫苗緊急使用授權 （EUA）的申請。
Corp. 公司(corporation的縮寫)a biopharmaceutical company生物製藥公司submit an application遞交申請
The announcement came only a few days after the company unblinded the phase 2 study for its domestically manufactured vaccine.
日前國產高端疫苗二期臨床試驗解盲，
unblind(v.)解盲placebo(n.)安慰劑phase(n.)(月亮的)位相;盈虧、(發展或變化的)階段;時期=stagedomestically-manufactured=locally-made=locally produced 本土製造的
Participants in the second stage trials received their second dose of the vaccine on April 28.
第二階段試驗的參與者於4月28日接種了第二劑疫苗。
stage(n.)階段trial(n.)試驗、試用clinical trials臨床試驗
Preliminary results showed that the vaccine raised no major safety concerns.
初步結果顯示，高端疫苗沒有重大安全疑慮。
preliminary(adj.)初步的、起始的、預備的=initial
To meet the requirements for the EUA, Medigen will need to present data of at least 3,000 subjects to back up the safety of the vaccine.
為了符合EUA的標準，高端將需提供至少3,000名受試者的數據以支持疫苗的安全性。
meet the requirements for…符合…的要求present(v.)(正式)提出subject(n.)受試者 back up=support支持
In addition, its efficacy test results must be at least on par with the AstraZeneca vaccine from Britain.
另外，疫苗的藥效測試結果不得低於英國AZ疫苗。
in addition=additionally此外efficacy(n.)功效、效力、效能=effectiveness
Immunobridging, an approach to infer the protective effect of a vaccine by measuring immune responses in participants of a clinical trial, will be used in reviews of the EUA for locally-developed COVID-19 vaccines, according to Taiwan’s Food and Drug Administration.
且食藥署指出，將根據免疫橋接研究結果對本土疫苗進行EUA審查，免疫橋接是一種透過檢驗臨床試驗參與者的免疫反應，推測疫苗保護力的方法。
immunobridging免疫橋接immune(adj.)免疫的immune system免疫系統immune response免疫方法infer(v.)推論;推斷Food and Drug Administration=FDA食藥署
In the meantime, Medigen is seeking international cooperation in phase 3 clinical trials of the company’s vaccine with an eye to obtaining permits for global rollout.
同時，高端正在尋求該疫苗三期臨床試驗的國際合作，以獲得全球上市許可。
in the meantime=meanwhile=at the same time同時with an eye to V-ing (N.)為了…=with a view to…=for the purpose of…permit(n.)許可;許可證(v.)允許a work permit工作許可rollout(n.)首次提供(產品或服務);上市
The company said in a statement that it has signed a memorandum of understanding with the National Institute of Hygiene and Epidemiology under the Ministry of Health in Vietnam and National University of Asuncion in Paraguay to conduct the clinical trials in those countries.
高端公司在一份聲明中指出，日前分別與越南國家衛生暨流行病學研究所（NIHE）及巴拉圭亞松森大學醫學院簽署合作備忘錄，擬於這些地區合作執行新冠疫苗臨床試驗。
memorandum of understanding=MOU合作備忘錄;諒解備忘綠conduct(v.)(正式)進行=carry out
It is also negotiating with other Southeast Asian countries over COVID-19 vaccine development and business cooperation projects, according to the statement.
此外，高端也正與東南亞各國洽談研發及業務合作。
negotiate with sb. (over sth.) 與某人(針對某事)協商