[心得] 韓國
South Korea’s COVID-19 vaccine candidates can be evaluated through
comparison with previously authorized vaccines.
This means domestic vaccine developers will no longer have to
recruit large control groups for a phase 3 clinical trial.
According to the Ministry of Food and Drug Safety on Wednesday,
the government has revised guidelines for phase 3 clinical trials
in a bid to accelerate the development of homegrown vaccines against COVID-19.
Under the new rules, drugmakers would need just 4,000 volunteers
to conduct a phase 3 clinical study of a vaccine candidate.
Based on the findings, they can compare the immunogenicity of an already
authorized vaccine with one under development to prove its efficacy.
Cross-platform comparisons between already authorized vaccines and
a candidate of a different type are also allowed.
Several South Korean firms are developing vaccines now, including Genexine,
which is developing a DNA vaccine against the novel coronavirus.
There are currently no DNA-based COVID-19 vaccines anywhere,
meaning that Genexine has no authorized DNA vaccine that the company
can compare with its vaccine candidate.
http://www.koreaherald.com/view.php?ud=20210630001048
韓國為了加速國產疫苗的進程 FDA已核准免疫橋接取代傳統三期
而且不限於同種疫苗間的比較 所以韓產的DNA疫苗亦可和現有疫苗比較
再次打臉一堆以為只有自己說的是科學的偽科學仔 ~
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陳培哲: 這些研究數據在科學上一點價值都沒有,
因為抗體效價不等於實際打疫苗的保護力,
這是沒有用的數字,他連看都不想看
院士 ? 打著科學名號反科學 我呸 ~
推
08/06 18:11,
4年前
, 1F
08/06 18:11, 1F
不過是個踐踏自己專業為政治服務的角色罷了 ~
推
08/06 18:27,
4年前
, 2F
08/06 18:27, 2F
其實不止日韓 法國也有支疫苗在做免疫橋接了
現在國際上有疫苗廠牌的國家只有英美德中俄
對還未有國產疫苗的國家來說 免疫橋接絕對是未來趨勢
因為疫苗就是戰略物資 加速扶持國產避免受制他國本來就是正確的
※ 編輯: ensuey (36.229.242.97 臺灣), 08/06/2021 18:42:35
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