Medigen Worked With Chinese Firm on Clinical Trial? 高端二期試驗與中資合作 外界疑慮個資外洩

There are reports that Caidya, a company contracted to conduct the phase 2 clinical trial for Medigen's COVID-19 vaccine, is a Chinese-funded company. Health and Welfare Minister Hsueh Jui-yuan has provided an explanation.

Controversies continue to swirl around Medigen's COVID-19 vaccine, which was domestically developed and manufactured. A legislator recently said a Chinese-funded company called Caidya was contracted to jointly conduct the vaccine's phase 2 clinical trial and expressed concerns that the personal information of Taiwanese people could be leaked.

Wang Mei-hua, Economic Affairs Minister: “I don't think the Ministry of Economic Affairs is responsible for Medigen's phase 2 trial. It would be better if the Ministry of Health and Welfare is the one that explains.”

The Ministry of Health and Welfare said Caidya was the subsidiary of an American company in Taiwan when it signed the contract with Medigen. Earlier this month, the parent company merged with a Chinese enterprise. However, Caidya remains a legal contract research organization in Taiwan. The Food and Drug Administration can reexamine the storage of data. Numerous research organizations including NTU Hospital are planning to contract Caidya to conduct clinical trials.

Hsueh Jui-yuan, Health and Welfare Minister: “We will conduct a GCP verification to see whether it conformed to protocol at the time it accepted the case and whether it safely stored the data it received.”

Lin Wei-cheng, Specialist, Medicinal Products Division, FDA: “The personal, internal, and private contractual relationship between Medigen and Caidya is not something that this government entity can get involved with.”

The FDA said the focus should be on whether the final clinical trial data provided by Medigen conforms to the good clinical practice standard. Medigen was responsible for that part. It issued a statement saying clinical trials are always conducted in accordance with standards to protect the rights of subjects and the reliability of trial data.
 

國產高端疫苗爭議不斷，新冠二期臨床試驗遭立委批評，是找中資公司丘以思合作，質疑國人臨床試驗個資恐怕有外洩疑慮。

經濟部長王美花說：「高端的二期這個，我想這個不是經濟部負責，這個還是由衛福部來說明。」

對此衛福部長薛瑞元表示，丘以思與高端簽約時是美商在台灣的子公司，雖然母公司在今年10月與中國企業合併，但丘以思仍是國內合法的受託研究機構CRO，食藥署可就資料保存部分再重新審查，目前包括台大醫院等多家研究單位，也都有委託丘以思公司進行臨床試驗計畫。

衛福部長薛瑞元指出：「在他們收案的時候，是否符合當時試驗的計畫，然後他所收到的數據，是否有安全的去做保存，這些都會去做GCP（藥品優良臨床試驗規範）的查核。」

食藥署藥品組技正林委正說道：「高端公司它自己跟丘以思公司自己內部的，私底下的私人契約關係，這個部分也不是我們官方這邊，審查端能夠涉入。」

食藥署強調，高端最終臨床試驗資料，是否符合「藥品優良臨床試驗作業準則」才是重點，且結果由高端公司負責。而高端則是發聲明回應，臨床試驗皆有一定嚴謹程序，會依循規範標準進行，以確保受試者的權利、及臨床試驗數據的可信度。