2022/5/26  
Medigen wins international grant to conduct mixed-dose booster trial (2021/12/03)
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  • 英文 English 
    Medigen wins international grant to conduct mixed-dose booster trial (2021/12/03)

    Taiwanese biotech firm Medigen has won a US$2.3 million international grant to test its COVID-19 vaccine as a mixed-dose booster shot. The grant, which is worth more than NT$60 million, was awarded by a global initiative backed by the Bill & Melinda Gates Foundation. Medigen said it would recruit 960 fully vaccinated subjects in Taiwan for its upcoming trial.

    Phase III tests for Medigen are unfolding overseas. One study in Paraguay has just completed recruitment, while the WHO’s Solidarity trial is also getting underway. In the latest development, Medigen has won a grant from the Coalition for Epidemic Preparedness Innovations, a group that’s backed by the Bill & Melinda Gates Foundation. With the grant, which is worth more than NT$60 million, Medigen will conduct mixed-dose booster trials in Taiwan.

    Charles Chen
    Medigen general manager
    Regarding mix-and-matched booster shots – sometimes when you use the original vaccine, for instance an mRNA or adenovirus vaccine, you may not see the expected effect. Or the side effects might be more severe. So they see subunit protein vaccines as an option with great potential.

    For the trial, Medigen plans to recruit people who have received two doses of AstraZeneca, Moderna, or Medigen. A total of 960 subjects will be randomly assigned to receive a booster shot. They might receive a full or half dose of Medigen, a half dose of Moderna, or a full dose of AstraZeneca. Subjects will be followed up on for six months, to collect data on the persistence of their immune response after vaccination. Interim results are expected in the first quarter of next year. In related news, Medigen said it’s investigating the efficacy of its vaccine against the omicron COVID variant, by building a pseudovirus using the beta strain.

    Charles Chen
    Medigen general manager
    We are constructing what’s called a pseudovirus. This is already a work in progress. So I think that very soon, we’ll be able to take in people who have already received two or three doses of Medigen, and run tests on their serum antibodies. So I hope to have an answer to report to you all very soon.

    Chen Shih-chung
    CECC
    I believe that Medigen is receiving funding based on the outcome of expert assessments of its trial data and other empirical results. That is the reason for these groups’ sizeable investment. I believe that everyone will be able to agree that Medigen has a very high probability of success.

    Health minister Chen Shih-chung expressed high hopes for Medigen. The domestic developer is making headway toward becoming a booster shot of choice. It’s also working on testing its vaccine against omicron, in hopes of gaining wider global recognition.
    中文 Chinese  
    高端獲補助6千多萬 在台混打第3劑臨床試驗

    高端疫苗獲得國際組織補助六千多萬,將在台灣進行混打第三劑臨床試驗,預計招募960名打完兩劑AZ、莫德納和高端的受試者,隨機分配施打第三劑,選項包括一劑或半劑高端、半劑莫德納以及一劑AZ,預計明年第一季可取得初步期中分析結果,陳時中也肯定,高端未來取得國際認證機會高。

    國產高端疫苗,國外三期臨床,除了巴拉圭計畫收案完成,WHO的團結疫苗試驗也正進行當中,最近又與比爾蓋茲基金會贊助的國際組織"流行病預防創新聯盟"合作,獲得補助六千多萬台幣,將在台灣進行第三劑混打臨床試驗。

    [[高端疫苗總經理 陳燦堅]]
    “混打第三劑這個加強劑,有時候你在用原型劑,比如說mRNA 或腺病毒,也許不見得預期的效果,或者是副作用不曉得會不會更嚴重,次單位蛋白疫苗,就被他們覺得是一個很有潛力的(選擇)”

    試驗預計招募打完兩劑AZ、莫德納和高端的民眾,一共960名受試者,隨機分配施打第三劑,選項包括一劑或半劑高端、半劑莫德納以及一劑AZ,並追蹤六個月評估,期盼蒐集免疫反應持久性的相關數據,預計明年第一季可取得期中分析結果。只是不管打兩劑還是三劑,究竟能否對抗南非新變種病毒。

    [[高端疫苗總經理 陳燦堅]]
    “事實上我們也在架構一個叫做假(偽)病毒,這個已經在進行了,所以我想很快我們就可以,用手邊已經打過高端三針,或打兩針(民眾) ,把這些血清(抗體) ,來做這樣的測試,所以我希望很快有答案,可以跟各位報告”

    [[疫情指揮中心指揮官 陳時中]]
    “我相信這都是經過這些專家裡面,去看它一些實驗的資料,跟它一些實證的一個情況,所以才會做這麼大的一個投資,那我相信是大家也認可,(高端)它會成功的可能性是很高的”

    指揮官陳時中也寄予厚望,有關次世代疫苗規劃,高端表示,不只採取第三劑加強針,也針對南非變異株積極研發,期盼國內外都能獲得認證。
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