Experts Say Further Monitoring Required as Medigen Granted First EUA Domestically 高端疫苗獲緊急授權 專家呼籲持續觀察

The COVID-19 vaccine developed by Medigen has received emergency use authorization from the government, becoming the first domestic vaccine that gets green light to begin mass production. Medigen CEO Charles Chen said his firm should be able to produce 10 million doses by the end of this year, with the first batch becoming available in August at the earliest.


Medigen has become the first domestic pharmaceutical to receive emergency use authorization for its COVID-19 vaccine. While making the announcement, the Food and Drug Administration also said Medigen's average neutralizing antibody level was 375 compared to AZ's 130. Domestic experts say a conclusion on which vaccine is better overall can't be drawn from this. 

Voice of Ho Mei-chin, Joint Appointment Research Fellow, Academia Sinica:”Neutralizing antibody levels are correlated positively with the levels of protection, but the ratio isn't always 1:1. In other words, just because the vaccine induces an antibody level three times higher than other products doesn't mean it is three times more effective. “

Experts say neutralizing antibody levels are only one measure of a vaccine's overall efficacy. For example, research has shown that AZ vaccines provide protection for up to eight months. They also said Medigen must continuously monitor its vaccine's side effects after it hits the market.

Voice of Huang Li-min, Honorary Chair, Infectious Diseases Society of Taiwan:”You might see a link between the AZ vaccine and thrombosis, but the thrombosis rate could be 1 in 100,000 or even lower. You won't see that in clinical trials, so vaccines must be monitored (after they hit the market).”

Experts say a conclusion has not been made regarding the ideal or minimum neutralizing antibody levels at this point and vaccines must be closely monitored after they hit the market. They also say Medigen and UBI Asia need to complete Phase 3 clinical trials overseas if they want to obtain international recognition.

 

 

高端新冠疫苗通過緊急使用授權EUA,成為首支允許專案製造的國產疫苗!衛福部食藥署指出,高端疫苗的中和抗體幾何平均效價為375,AZ疫苗則約130,對此專家表示,這代表高端疫苗的中和抗體生成情況,確實優於AZ疫苗。

中研院生醫研究所兼任研究員 何美鄉:「中和性抗體的高呢跟低呢,是跟保護性有呈正相關,但是正相關不一定是一個1:1。就是我是你的三倍,那我的保護性就是你的三倍,不是這樣。

專家表示,中和抗體只是疫苗保護效果的評估指標之一,但並不是說、中和抗體越高,就一定是優於其他品牌,例如AZ疫苗,研究發現它的保護力、可以長達8個月;另外,疫苗上市後,也要持續監測接種後不良事件。

台灣感染症醫學會名譽理事長 黃立民:「AZ疫苗你就看到說它會有血栓,那這個血栓的比率,可能是十萬分之一或是更低。那這個在臨床試驗是看不見的,所以(上市後)監視是必要的。」

專家表示,目前國際上尚未討論出、到底中和抗體要達到多少,才具有效性,因此疫苗上市後,仍要持續監測,此外近期國內疫情趨緩,建議國產疫苗還是應該到國外、進行三期臨床試驗,才有助於國產疫苗進軍海外市場,獲得國際認證。

相關新聞

專題|全台敬老金大調查