Medigen CEO Prioritizes Boosting of Production 高端總經理稱 當前首要目標是衝產量

Medigen Vaccine Biologics Corporation held a shareholders meeting on Aug. 17. CEO Charles Chen said the most important current objectives are "increasing production to serve the country" and "international connections." He hopes the company's COVID-19 vaccine can be used by both the people of Taiwan and allies. Meanwhile, experts say Medigen has failed to provide related information on the efficacy of its vaccine.

Medigen Vaccine Biologics Corporation held a shareholders meeting on Aug. 17. The meeting started at 9 a.m. and ended one hour later. Numerous minority shareholders attended to show their support. 

Medigen Minority Shareholder:“There are opportunities for the vaccine to be supplied overseas.”

Medigen CEO Charles Chen spoke to the media after the meeting. He thanked the shareholders for their support and revealed that the company's current objectives include increasing output to make up for Taiwan's severe vaccine shortage.

Charles Chen, CEO, Medigen Vaccine Biologics Corp.:” The first is to increase production to serve the country. The second is of course forging international connections. We will be able to help our allies after domestic demand is met.”

Chen expressed confidence in the quality of the vaccine developed by his company. Last week, the Food and Drug Administration published the complete Chinese language manual for Medigen's vaccine. Experts had doubts after reading the manual. They pointed out that the fourth special warning and a usage note both said the "protection period" offered by the vaccine is "uncertain" and needs to be further determined by ongoing clinical trials. Meanwhile, in the section on "limitations of vaccine effectiveness," the manual said that neutralizing antibodies will be generated two weeks after the second dose of the Medigen vaccine is administered "just like all other vaccines" and the Medigen vaccine does not necessarily have a protective effect on everyone. In response, the FDA said the Medigen vaccine was manufactured on an emergency use authorization project basis, and therefore has not completed stage 3 clinical trials. This is why these warnings were included.

Voice of Wu Ming-mei, Deputy Director, Medical Products Division, FDA:” The stage 2 clinical trial won't end until six months after the second dose is administered, so the data won't come out until the final report in October or November. With regards to the EUA, it's because there was an application under emergency circumstances and we had to quickly administer the vaccine to produce protection. If we had to wait until the stage 3 trial was completed, then the epidemic situation might have been even worse or more severe.” 

The FDA's website has manuals in Chinese for the AstraZeneca and Moderna vaccines. There are similar warnings in the "protection period" and "limitations of vaccine effectiveness" sections. Medigen vaccines are available for the sixth round of inoculation. Over 300,000 people have indicated their willingness to receive the vaccine. Scholars and experts say Medigen needs to dispel all doubts about the efficacy.

高端疫苗，上午9點，召開股東會，約一小時後順利散會，不少小股東親自參加力挺高端。

高端小股東：「（高端疫苗）有機會可以向國外供應。」

會後總經理陳燦堅，接受媒體訪問，除了感謝股東支持外，他提到高端現階段目標，就是衝產量，補足疫苗缺口。

高端總經理 陳燦堅：「第一個就是增產報國，第二個當然就是國際連結使用無虞的情況下，可以幫助我們的友邦。」

陳燦堅對高端疫苗品質很有信心，不過上週食藥署公布，高端疫苗完整中文說明書，有專家指出，在第四點特殊警語及使用注意事項，關於"保護效期"部份提出質疑，因為內文中寫著，可提供的保護效期不明，仍須由進行中的臨床試驗進一步確定。另外，在"疫苗效果的限制"部份，內文也寫著，第2劑高端打完約2週後，開始有中和抗體反應，"如同所有疫苗"，高端不一定對所有人都能產生保護作用。不過，食藥署澄清， 因為高端疫苗，主要是緊急使用授權專案製造，尚未完成三期臨床試驗，才會加註相關警語。

食藥署藥品組副組長 吳明美：「整個第二期臨床試驗的執行期程，是要打完第二劑之後6個月，所以數據大概是10月 11月期末報告才會出來。那EUA的話就是，因為公衛申請緊急情勢啊，我們要趕快打疫苗產生保護力啊，不然等到第三期整個都走完的話，可能疫情會影響更大或更嚴重啊。」

食藥署官網上，也有提供AZ疫苗、莫德納疫苗中文說明書，翻閱內容，在"保護效期"、疫苗效果的限制"的部份，也有一樣加註"相關警語。不過，高段疫苗第6輪疫苗首日接種預約，已超過30萬人，部份專家學者認為，是否有保護力，高端仍應完整向國人釋疑。