為達最佳瀏覽效果,建議使用 Chrome、Firefox 或 Microsoft Edge 的瀏覽器。

請至Edge官網下載 請至FireFox官網下載 請至Google官網下載
晴時多雲

    限制級
    您即將進入之新聞內容 需滿18歲 方可瀏覽。
    根據「電腦網路內容分級處理辦法」修正條文第六條第三款規定,已於網站首頁或各該限制級網頁,依台灣網站分級推廣基金會規定作標示。 台灣網站分級推廣基金會(TICRF)網站:http://www.ticrf.org.tw

    《TAIPEI TIMES》 Medigen optimistic over trials

    From left, Medigen Vaccine Biologics Corp head of development Lien Chia-en, chief executive officer Charles Chen and spokesman Leo Lee attend a videoconference in Taipei yesterday.
Photo: Screen grab from the Internet

    From left, Medigen Vaccine Biologics Corp head of development Lien Chia-en, chief executive officer Charles Chen and spokesman Leo Lee attend a videoconference in Taipei yesterday. Photo: Screen grab from the Internet

    2021/06/11 03:00

    PHASE 2: The firm’s CEO said that the results were good and the experimental vaccine safe, but added that hoped-for phase 3 trials would be expensive

    By Kao Shih-ching / Staff reporter

    Medigen Vaccine Biologics Corp (高端疫苗) yesterday reported positive results from an interim analysis of phase 2 trials for its COVID-19 vaccine, saying that the vaccine demonstrated high seroconversion rates and geometric mean titer (GMT) figures.

    A seroconversion rate is the percentage of participants in a trial displaying virus-specific immune memory after being given a vaccine, while the GMT measures the level of neutralizing antibody response, Medigen said.

    The experimental vaccine has a seroconversion rate of 99.8 percent and its GMT was 662 among the participants aged 20 to 89, while the gauges rose to 99.9 percent and 733 respectively in participants aged 20 to 64, the company said.

    No participants have shown severe adverse reactions, it said.

    Only 0.7 percent of participants who were given experimental vaccines had a fever, compared with 0.4 percent in those who received a placebo, while among those who received the vaccine 27.6 percent had muscle soreness and 36 percent felt tired, compared with 16.6 percent and 29.7 percent respectively for those who were given a placebo, it said.

    “It would be the regulator that decides if our experimental vaccine has good efficacy, but I personally found the results — the seroconversion rates and the GMT figures — optimistic,” Medigen chief executive officer Charles Chen (陳燦堅) said.

    “And it is very safe,” Chen added.

    The company will apply to the Food and Drug Administration for emergency use authorization as soon as possible, he said.

    However, asked which COVID-19 vaccine developed outside Taiwan that has been granted emergency use authorization Medigen’s experimental vaccine might be compared to, the company said it has not reached a conclusion.

    “An estimate needs to be done scientifically. We can conduct an immune-bridging study to compare the antibody levels in people who are given different COVID-19 vaccines, and the WHO is also trying to establish common standards for COVID-19 vaccines,” Medigen head of development Lien Chia-en (連加恩) said.

    For example, Medigen’s clinical trial result of a GMT of 662 could be converted into international units (IU) and foreign vaccine developers could do likewise to enable international comparison, Lien said.

    “However, this would take some time and other companies have not disclosed their data in IU yet,” he said.

    Amid discussions over whether locally developed COVID-19 vaccines would be better than foreign vaccines, Chen and Medigen spokesman Leo Lee (李思賢) said that they are confident in their product and they and their families would get Medigen’s vaccine.

    Medigen is to conduct phase 3 trials for its vaccine to earn approval from foreign regulators and it aims to conduct the tests in Europe, Chen said, adding that the UK recently allowed a French company to conduct phase 3 human testing there.

    It costs about US$10,000 per participant in phase 3 trials, so the costs would be enormous if Medigen recruited 30,000 participants, Chen said.

    新聞來源:TAIPEI TIMES

    不用抽 不用搶 現在用APP看新聞 保證天天中獎  點我下載APP  按我看活動辦法

    焦點今日熱門

    網友回應

    此網頁已閒置超過5分鐘,請點擊透明黑底或右下角 X 鈕。