Medigen Efficacy Similar to Other Vaccines: Experts 預防中重症.死亡 高端保護效益與他疫苗相近

An expert meeting was held on Nov. 3 to review Medigen vaccine's effectiveness. The 14 participants passed an unanimous decision, supporting that the product meets required standards.

The Emergency Use Authorization for Medigen COVID-19 vaccine remains in effect after the Food and Drug Administration of the Ministry of Health and Welfare held an expert meeting on Nov. 3. The 14 attending experts reviewed its protection assessment report and newly submitted data regarding its effectiveness against severe or fatal cases in older adults, and unanimously passed the decision that the vaccine has the required effectiveness standards.

Wu Ming-mei, Deputy Chief, Medicine Div., Food and Drug Administration: “With respect to its protection against severe cases of death, the efficacy is similar to BNT and Moderna.”

The Food and Drug Administration says data provided by Medigen Vaccine Biologics Corp shows that the recipients of its vaccine have a similar level of protection as those who received AZ, BNT, Moderna, or mix-and-match doses. The finding is also valid in those aged 65 years and older. However, former Director of Health Promotion Administration Chiou Shu-ti accused Medigen Vaccine Biologics of violating international standards as it did not conduct Phase III random sampling clinical trials. Chiou said the company's decision to put its vaccine on the market lacks scientific support and violates human rights, treating the Taiwanese as fools and their lab rats.

Chiou Shu-ti, Former Director of Health Promotion Administration: “Right before the elections, you suddenly decide to hold a meeting to endorse Medigen. But does that change the fact that those Taiwanese who received Medigen vaccines must either get PCR or get re-vaccinated to go to Japan? No, it does not and nothing has changed. The whole world has not changed one bit as a result of these 14 rubber stamps.”

With respect to this, the FDA responded and said Medigen did conduct Phase III clinical trials in Paraguay as well as in WHO's Solidarity Trial Vaccines, but the FDA awaits the complete report and further explanation from Medigen Biologics. While the epidemic remains severe, Medigen's EUA will be upheld.

衛福部食藥署3日晚間召開專家會議，針對高端保護效益評估報告，及補充提供年長者、重症及死亡保護力等資料進行審查，結果與會專家14人全票通過，認同高端疫苗的保護效益。

食藥署藥品組副組長吳明美指出：「對於預防中重症或者是死亡的保護效益，其實它們的效果都是相近的，跟BNT還有莫德納比起來。」

食藥署表示，高端數據顯示，接種高端疫苗的國人，相較於接種AZ、BNT、莫德納或其他混打組合，其對於預防中重症、死亡的保護效益相近，在65歲以上年長者族群也有相同保護效果。不過前國健署長邱淑媞質疑，高端違反國際規範，不做3期「隨機分派」臨床試驗，把國人當白老鼠，不僅不科學，也違反人權，簡直把全民當傻瓜。

前國健署長邱淑媞批評：「你到了選前，你突然決定你們要來開一個會，全部給它背書蓋章。但是有改變我們國人去日本必須做PCR，要不就要補打的這個事實嗎？沒有改變什麼，什麼都沒有改變。全世界都沒有因為這10幾個橡皮圖章，而改變任何事情。」

對此，食藥署回應表示，高端公司有在巴拉圭、世衛組織WHO的團結疫苗試驗中，進行第3期試驗，但完整報告有待高端公司說明。目前高端在疫情緊急狀況未結束前，EUA將持續維持，下午指揮中心記者會將統一說明相關細節。