只能說你英文有點不好,翻譯解釋不完全正確,
但是我稍微看完,韓國食藥署的目的,
就是降低疫苗開發的時間、與成本,
提高廠商疫苗研發的意願,
這個跟生物統計的信賴區間有關,
台灣可以參考依循,降地成本與研發時間
韓國如何發展成為生技大國的案例。
※ 引述《permoon (有志難伸優質寫手ㄉㄉ)》之銘言:
: http://www.koreaherald.com/view.php?ud=20210630001048
: S. Korea eases rules for phase 3 clinical trial of new COVID-19 vaccine
: 韓國先驅報,記者 Shim Woo-hyun
: 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.
: 韓國的COVID-19疫苗可以與現有的疫苗進行免疫橋接對照實驗,
: 這代表未來韓國的疫苗不須招募大量的受試者進行第三期對照實驗。
他這段是說:「國內在臨床第三期的疫苗研發,
不再需要招募大量控制組人數來做比對。」
並不是指完全不需要招募大量受試者做比對!!!!!
:
: 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.
:
: 韓國食藥署周三宣布,修改第三期實驗的指導方針來加快國產疫苗開發。
:
: 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.
:
: 修改後只需要4,000名受試者就可以了。(對照台灣,高端擴大二期收案數=3,700)
這段意思是:「針對候選疫苗,
只需要4000受試者就可以執行三期臨床試驗。」
:
: Cross-platform comparisons between already authorized vaccines and a
: candidate of a different type are also allowed.
:
: 允許與現有的疫苗進行免疫橋接對照比較。
這段意思是:「允許現有核可上市的疫苗,
與其他不同種類的疫苗做(校標關聯效度)的比較,
來了解疫苗對新冠肺炎的有效性。」
(目前世界授權的三種新冠疫苗,分別採用以下三種技術:
1.去活疫苗/ 2.mRNA疫苗/ 3.次單位蛋白疫苗 )
:
: 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.
:
: 這段講的是韓國選擇的DNA疫苗技術,世界上沒有同樣技術的疫苗可以比較。
: (台灣鍵盤疫苗專家鄉民:為什麼不選腺病毒跟mRNA呢? 幹嘛不學中國做減毒呢?)
這段在講:「一些韓國公司(如Genexine)正在研發疫苗,
而他們正在研發的疫苗是DNA疫苗,
現在DNA疫苗沒有任何與其他疫苗比較的資料,
意思是Genexine所生產的疫苗與其他已授權的DNA疫苗做比較的資料」
:
: The Health Ministry said vaccine developers should consult with the ministry
: when designing cross-platform comparisons to decide the proper vaccine for
: comparison.
: The minimum number of participants needed for a phase 3 clinical study was
: previously 10,000.
這段意思是:「以前韓國食藥署針對不同種技術的疫苗做臨床三期的比較,
需要至少10000名受試者」
: In terms of a cross-platform comparison, vaccine developers will need to
: secure 3,000 subjects to be administered with a new vaccine and 1,000
: subjects who have been already vaccinated with an existing vaccine, according
: to the ministry.
這段意思是:「現在韓國改成只需要4000人參與新疫苗的臨床三期,
其中3000人當試驗組接種正在臨床試驗的新疫苗;
1000人當控制組,接種目前已在市面上授權的疫苗。」
: The revision is expected to help local pharmaceutical companies speed up
: development of COVID-19 vaccines and ease difficulties in securing
: placebo-controlled subjects who have not been vaccinated, the ministry
: expected.
: Domestic firms have experienced difficulties in recruiting enough test
: subjects, particularly placebo-controlled subjects, as more and more people
: are getting vaccinated these days.
: The ministry expects that the new guideline will also help local firms save
: on spending for their clinical studies.
這段意思是:「這個新的臨床研究案修正,
希望節省疫苗在臨床研究的開銷。」
: Meanwhile, the Health Ministry has also set up new articles in the guideline
: that allow for vaccine developers to be able to test their vaccines against
: COVID-19 variants.
:
: 剩下的不太重要了,主要是韓國政府希望幫國產疫苗廠商減少開支。
: (台灣鄉民:叭叭叭叭!!炒股!!圖利!!割韭菜!!!)
:
: BTW其實日本也快通過免疫橋接取代原本的大規模收案的三期了,
: 台灣有沒有領先世界窩補知道,但一定是領先日韓的,
: 至於他們的國民有沒有跳出來說政府屠殺人民或割韭菜,我就不知道了,
: 等各位國際觀滿分的八卦版鄉民教育我。