United Biopharma Applying Again for EUA Approval 聯亞爭取EUA 將提科學證據拚第二次審查

Domestic vaccine producer United Biopharma has not received the emergency use authorization from the Food and Drug Administration. The company stated that it will present scientific evidence such as "viral immune memory" and resubmit its application at the end of this year. Additionally, the country’s self-purchased 1.1 million Moderna doses arrived in the evening. And the seventh batch of BNT vaccine arrived early this morning.
 


Moderna and BNT vaccines arrive in the country one after another! The 1.1 million doses of Moderna vaccine purchased by Taiwan left the US on the morning of the 8th and arrived in the country in the evening. In addition, more than one million doses of BNT vaccine donated by businesses and private groups including the Yongling Foundation, TSMC, and Tzu Chi arrived at around 5 am this morning. They will be tested and sealed before being distributed to the public. Medigen has been the only domestically produced vaccine to have received EUA approval. United Biopharma has submitted its EUA application for the second time. The company claims their vaccine has "viral immune memory", which can accurately eliminate the virus when it enters the body.

Peng Wen-jiun, Executive Vice President, United Biopharma:"We proved our vaccine's immune memory. Once vaccinated, if you are infected, our vaccine can stir a strong immune memory to attack this virus."

United Biopharma stated that a recent Academia Sinica study found antibody titer reached about 4,000 times, an increase of 37 times when the third dose of their vaccine was administered after 8 to 10 months. This surpassed Novavax, Moderna, and BNT, proving that United Biopharma's vaccine can maintain a longer immune memory in the human body. It is also effective against the Delta variant but this doesn't mean that the third dose must be administered.

Peng Wen-jiun, Executive Vice President, United Biopharma:"We can achieve long-term immune protection based on our antibody titer against both the new variant or the one already in the body."

In the first EUA review rejected by the FDA, United Biopharma's neutralizing antibodies were not as good as that of AZ. The most primitive Wuhan virus strain was used for testing at the time. The company emphasized that it followed up with the FDA to adjust EUA review criteria and hope that it will be officially submitting its vaccines for review again before the end of the year. 

 

 

 

莫德納與BNT疫苗相繼來台!我國自購的110萬劑莫德納疫苗,8號上午已經從美國起飛,已經在傍晚抵運抵台灣;另外,由鴻海永齡、台積電及慈濟等企業民間團體採購捐贈的BNT疫苗100多萬劑,清晨5點多已經到貨,後續將進行封緘檢驗,再給民眾接種。而在國產疫苗部分,除了高端、已通過國內緊急使用授權EUA,聯亞生技也將提出更有利的科學證據,力拼第二次EUA審查,其中包括聯亞主張,疫苗具有「病毒免疫記憶」的功能,當病毒入侵時,能精準消滅病毒。

聯亞生技執行副總 彭文君表示:「我們證明了這個免疫記憶性,一旦打了疫苗之後,被感染的時候,它就可以喚起很強的免疫記憶性,來攻擊這個新冠的病毒。」

聯亞生技表示,近期委託中研院做的研究發現,相隔8到10個月、再打第三劑,抗體力價達4千倍左右,上升幅度37倍,勝過Novavax、莫德納及BNT,顯示聯亞疫苗可以在人體維持較久的免疫記憶,而且對抗Delta印度變異株也很有效,但不代表一定要打到第三劑。

聯亞生技執行副總 彭文君表示:「不管是變種病毒,或者是維持身體裡面的,這個抗體力價來講的話,我們是可以做到長期免疫保護性的。」

由於聯亞疫苗在食藥署第一次EUA審查中,中和抗體效價不如AZ,且採用比對的是最原始的武漢病毒株,最後鍛羽而歸,未能通過,因此聯亞生技強調,後續將和衛福部食藥署溝通,調整EUA的審查條件,希望年底前能正式送審。

 

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