Medigen Granted EUA but Vaccine Lacks Credibility 高端通過EUA列公費施打 然外界仍疑慮

Responding to questions and worries regarding Taiwan's first domestic vaccine, Medigen CEO Charles Chen received an interview, saying the vaccine also protects against the new Delta variant. Chen also said there are many vaccines in use that were developed through immunobridging.

On July 25, the Central Epidemic Command Center announced that Medigen's COVID-19 vaccines would be incorporated into the national vaccination program. However, the way the vaccine was rushed to market without a Phase 3 clinical trial has resulted in credibility issues and there is no evidence the vaccine offers any protection against the Delta variant. Medigen CEO Charles Chen dismissed public suspicions and criticism during a radio interview on July 26.

Charles Chen, Medigen CEO："From a scientific perspective, the different variants we're seeing are not completely different (from the original virus). So, I think the antigen we're using, combined with this adjuvant, can be effective."

During the interview, Chen claimed Medigen's vaccine protects against the original COVID-19 virus as well as the Beta and Delta variants, saying the variants are not vastly different from the original. However, it turns out that even the Food and Drug Administration expert panel that approved the emergency use authorization was not overly enthusiastic about the vaccine. Out of 21 experts, only three agreed unconditionally to the EUA. Fifteen granted conditional approval, which was lumped in with the unconditional approvals. Out of the remaining three, one requested further documentation, one rejected EUA approval, and one is the meeting moderator who cannot vote. People are wondering what "conditional approval" meant. Moderna and Pfizer completed Phase 3 clinical trials before they were approved by the US FDA. Novavax, which is developing a protein subunit vaccine similar to Medigen's, is currently conducting its Phase 3 trial and will not apply for a EUA until the trial is completed and unblinded. In contrast, Taiwan granted Medigen a EUA without a Phase 3 trial.

Charles Chen, Medigen CEO："When you're coming up with the rules of the game, there are some uncertainties or unknowns you have to account for. COVID-19 could be like seasonal flu, or it could be like SARS and disappear after a while. Taiwan did such an unimaginably wonderful job at preventing it from spreading that there simply was not an objective environment for conducting a so-called traditional Phase 3 clinical trial in the slightest. Our legal authorities and experts, therefore, came up with a standard on how to conduct what's called an "expanded Phase 2 clinical trial" that incorporated two concepts. One is called safety and the other is called efficacy."

Chen says there are many vaccines in use that were developed through immunobridging such as cervical cancer and vaccine development policies should be more flexible.

高端新冠疫苗日前順利取得緊急授權EUA，指揮中心25號也宣布納入公費施打，不過，外界對於這國產疫苗的爭議也持續延燒，包括沒有做三期臨床試驗 ? 是否能有效對抗Delta變種病毒?..等，高端總經理陳燦堅接受廣播節目專訪時回應了外界的疑慮。

高端疫苗總經理 陳燦堅：「目前，不管是南非株Delta株，它的變異就科學上來看，它不是一個非常全面性急遽的變化。所以我想，我們架構的這個抗原加上這個佐劑，是可以來應付的。」

陳燦堅表示，不管是對Beta南非株、Delta印度株，與原始的武漢株相比，都不是太大的變異，病毒是漸進式的變，是可以應付的。而在這回食藥署專家審查會議時，21位專家學者中，3位同意，15位有條件同意，1位希望補件，1位不同意，也讓外界好奇究竟有條件通過的條件到底是什麼?且國際上包括莫德納、輝瑞的新冠疫苗都有進入三期才被美國FDA核准，與高端一樣都是次單位蛋白的Novavax三期也在進行中，尚未拿到EUA，但高端卻連三期都還沒有開始台灣就可以使用。

高端疫苗總經理 陳燦堅：「在訂遊戲規則的時候，有幾個未確定的因素，新冠肺炎究竟是一個流感化的疫情? 還是它像SARS一樣來，一下就不見了?我們當時在台灣的時候，實在是守得太好了，也沒有一點可以有做所謂的傳統三期臨床實驗，這樣的客觀環境。當時我們的法規單位，以及專家們，他們就訂出一個規格就是說，怎麼樣來一個叫做擴大版的二期實驗，融入兩個概念，一個叫做安全，一個叫有效。」

陳燦堅表示，包括大家熟知的子宮頸癌疫苗當初也是使用免疫橋接，是全世界科學家認可方法，且這段時間新冠病毒一直被討論會流感化，隨著疫情變化跟供應鏈的調整，很多政策都該有彈性。