1.转录网址︰
https://reurl.cc/9rNMGX
2.转录来源︰
李秉颖FB
3.转录内容︰
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.
韩国的 COVID-19 候选疫苗可以通过与以前授权的疫苗进行比较来评估。 这意味着国内疫
苗开发商将不再需要招募大型对照组进行 3 期临床试验。
根据食品药品安全部周三的说法，政府已修订了 3 期临床试验的指导方针，以加快针对 C
OVID-19 的本土疫苗的开发。
根据新规定，制药商只需要 4,000 名志愿者即可对候选疫苗进行 3 期临床研究。 根据这
些发现，他们可以将已获批准的疫苗与正在开发的疫苗的免疫原性进行比较，以证明其功效
。
还允许在已获授权的疫苗和不同类型的候选疫苗之间进行跨平台比较。
几家韩国公司现在正在开发疫苗，包括正在开发针对新型冠状病毒的 DNA 疫苗的 Genexin
e。 目前在任何地方都没有基于 DNA 的 COVID-19疫苗，这意味着 Genexine 没有授权的 D
NA 疫苗可以与公司的候选疫苗进行比较。
卫生部表示，疫苗开发商在设计跨平台比较时应咨询卫生部，以决定合适的比较疫苗。
3 期临床研究所需的最低参与者人数此前为 10,000 人。
该部表示，在跨平台比较方面，疫苗开发商需要确保 3,000 名受试者接种新疫苗，以及 1,
000 名已经接种现有疫苗的受试者。
该部预计，此次修订有望帮助当地制药公司加快 COVID-19 疫苗的开发速度，并缓解确保未
接种疫苗的安慰剂对照受试者的困难。
随着越来越多的人接种疫苗，国内公司在招募足够的测试对象方面遇到了困难，尤其是安
慰剂对照的对象。
卫生部预计，新指南还将帮助当地公司节省临床研究的开支。
同时，卫生部还在指南中设立了新条款，允许疫苗开发商能够针对 COVID-19 变体测试他们
的疫苗。
4.附注、心得、想法︰
韩国政府484在炒股图利财团？
怎么可以修改三期试验规则？
怎么可以用邪恶的免疫桥接就通过
一定是绿共病毒传到韩国了
喔气气气气气！！