UBI Vaccine Rejected for EUA, Advised for Phase 3 Clinical Trial 聯亞疫苗EUA未過 專家建議做三期試驗

Taiwan's vaccine maker UBI Asia questioned the FDA's decision to not grant an EUA for the company's COVID-19 vaccines, which, the company believes, activate good T-cell responses. Experts say, however, that UBI should conduct a phase 3 trial in order to provide more evidence for vaccine efficacy.


Taiwan's Food and Drug Administration (FDA) has rejected United Biomedical Inc.'s (UBI) request for the Emergency Use Authorization (EUA) of its COVID-19 vaccine candidate on the 17th, saying that its data from phase 2 clinical trials showed it did not trigger enough antibodies to meet Taiwan's antibody standard. Head of the UBI COVID vaccine trials Hwang Kao-pin responded that T-cell responses should also be factored in along with the level of neutralizing antibodies when it comes to determining vaccine efficacy.

Hwang Kao-pin, Vice Chair, Infection Control Team, CMUH:” T-cell responses are very important. Memory T-cells protect against previously encountered pathogens and killer T-cells kill virus-infected cells.” 

Dr. Huang Li-min says UBI would have to conduct phase 3 clinical trials in order to offer more convincing data on whether its vaccine offers protection against the coronavirus.

Huang Li-min, Honorary Chair, Infectious Diseases Society of Taiwan:” Not enough B-cells are triggered in UBI's clinical trial data, so we cannot grant EUA to UBI. If UBI insists that their vaccine generates good T-cell responses, they need to go ahead with phase 3 trials.”

Former Health Minister Yaung Chih-liang, who has participated in UBI's phase 2 trials, called on the government to administer other authorized brands of vaccines for UBI trial participants at this time.

Yaung Chih-liang, Former Health Minister:” Participants in both experimental and control groups should be offered vaccination of some other brands that have been authorized. They should not bet their hopes on UBI vaccinations yet. We wouldn't want an outbreak to happen.” 

UBI made a formal statement saying that data from the company's phase 1 and 2 trials showed that their vaccines generated a good immune response by effectively activating T-cells and B-cells. It can be effective even against the Delta strain. In June, Taiwan's FDA made public its standards in granting EUA for locally developed COVID-19 vaccines, with the requirement being that the domestic vaccine candidates have to offer at least the same level of neutralizing antibodies as that of the AstraZeneca (AZ) vaccine. It was, however, based on the original Wuhan strain and not of the current variants. Other factors such as T-cell immune responses and long-term immunity have not been considered. UBI will make formal requests to Taiwan's Center for Drug Evaluation and FDA for further tests.


國產疫苗聯亞生技、未通過食藥署緊急使用授權EUA審查,主要原因是中和抗體數據,未通過審查標準,對此聯亞疫苗臨床試驗總主持人黃高彬認為,疫苗不能只看中和抗體效價,還得考慮T細胞反應,才是疫苗能否長期保護的關鍵。

中國醫藥大學感染管制中心副院長 黃高彬:「T細胞的反應是最重要的,因為我們T細胞的反應第一個它是有這種記憶的功能,第二個就是說我們的殺手細胞它可以去殺死這個,這些被病毒感染的這種細胞。」

而黃立民則是認為,聯亞要做第三期試驗,才更具有說服力。

台灣感染症醫學會名譽理事長 黃立民:「聯亞的B細胞目前不及格,所以我們沒有辦法給它緊急授權使用,可是如果聯亞一直宣稱它的T細胞有功能的話,它就要去做三期臨床試驗。」
而曾經參與聯亞二期臨床試驗的、前衛生署長楊志良,則是呼籲政府,應安排聯亞受試者施打其他疫苗。

前衛生署長 楊志良:「所有的受試者,不管是實驗組、還是對照組,都應該給他一個安排。安排什麼?施打有效的疫苗,不然他以為,我是實驗組,我打了實驗的疫苗可能也有效那將來就變成破口。」

對此,聯亞發聲明表示,經第一、二期臨床證實,聯亞疫苗可有效誘導T細胞毒殺病毒免疫力,與B細胞對病毒產生中和抗體,尤其對於印度Delta變異株,仍保有中和抗體效價;但食藥署今年6月才公告,以AZ疫苗產生的中和抗體力價,作為免疫橋接認定標準,未考慮目前流行病毒株,已並非武漢株,而且免疫橋接除了「長期」中和性抗體效價之外,也應納入T細胞免疫、長期免疫等,因此近期聯亞將向藥品查驗中心CDE、及食藥署,提出申訴。
 

專題|全台敬老金大調查