1.轉錄網址︰
https://reurl.cc/9rNMGX
2.轉錄來源︰
李秉穎FB
3.轉錄內容︰
S. Korea eases rules for phase 3 clinical trial of new COVID-19 vaccine
South Korea’s COVID-19 vaccine candidates can be evaluated through comparison w
ith 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 h
as revised guidelines for phase 3 clinical trials in a bid to accelerate the dev
elopment of homegrown vaccines against COVID-19.
Under the new rules, drugmakers would need just 4,000 volunteers to conduct a ph
ase 3 clinical study of a vaccine candidate. Based on the findings, they can com
pare the immunogenicity of an already authorized vaccine with one under developm
ent to prove its efficacy.
Cross-platform comparisons between already authorized vaccines and a candidate o
f a different type are also allowed.
Several South Korean firms are developing vaccines now, including Genexine, whic
h is developing a DNA vaccine against the novel coronavirus. There are currently
no DNA-based COVID-19 vaccines anywhere, meaning that Genexine has no authorize
d DNA vaccine that the company can compare with its vaccine candidate.
The Health Ministry said vaccine developers should consult with the ministry whe
n designing cross-platform comparisons to decide the proper vaccine for comparis
on.
The minimum number of participants needed for a phase 3 clinical study was previ
ously 10,000.
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.
The revision is expected to help local pharmaceutical companies speed up develop
ment of COVID-19 vaccines and ease difficulties in securing placebo-controlled s
ubjects 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 v
accinated these days.
The ministry expects that the new guideline will also help local firms save on s
pending for their clinical studies.
Meanwhile, the Health Ministry has also set up new articles in the guideline tha
t allow for vaccine developers to be able to test their vaccines against COVID-1
9 variants.
韓國的 COVID-19 候選疫苗可以通過與以前授權的疫苗進行比較來評估。 這意味著國內疫
苗開發商將不再需要招募大型對照組進行 3 期臨床試驗。
根據食品藥品安全部周三的說法，政府已修訂了 3 期臨床試驗的指導方針，以加快針對 C
OVID-19 的本土疫苗的開發。
根據新規定，製藥商只需要 4,000 名志願者即可對候選疫苗進行 3 期臨床研究。 根據這
些發現，他們可以將已獲批准的疫苗與正在開發的疫苗的免疫原性進行比較，以證明其功效
。
還允許在已獲授權的疫苗和不同類型的候選疫苗之間進行跨平台比較。
幾家韓國公司現在正在開發疫苗，包括正在開發針對新型冠狀病毒的 DNA 疫苗的 Genexin
e。 目前在任何地方都沒有基於 DNA 的 COVID-19疫苗，這意味著 Genexine 沒有授權的 D
NA 疫苗可以與公司的候選疫苗進行比較。
衛生部表示，疫苗開發商在設計跨平台比較時應諮詢衛生部，以決定合適的比較疫苗。
3 期臨床研究所需的最低參與者人數此前為 10,000 人。
該部表示，在跨平台比較方面，疫苗開發商需要確保 3,000 名受試者接種新疫苗，以及 1,
000 名已經接種現有疫苗的受試者。
該部預計，此次修訂有望幫助當地製藥公司加快 COVID-19 疫苗的開發速度，並緩解確保未
接種疫苗的安慰劑對照受試者的困難。
隨著越來越多的人接種疫苗，國內公司在招募足夠的測試對象方面遇到了困難，尤其是安
慰劑對照的對象。
衛生部預計，新指南還將幫助當地公司節省臨床研究的開支。
同時，衛生部還在指南中設立了新條款，允許疫苗開發商能夠針對 COVID-19 變體測試他們
的疫苗。
4.附註、心得、想法︰
韓國政府484在炒股圖利財團？
怎麼可以修改三期試驗規則？
怎麼可以用邪惡的免疫橋接就通過
一定是綠共病毒傳到韓國了
喔氣氣氣氣氣！！