http://www.koreaherald.com/view.php?ud=20210630001048
S. Korea eases rules for phase 3 clinical trial of new COVID-19 vaccine
韩国先驱报，记者 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.
韩国的COVID-19疫苗可以与现有的疫苗进行免疫桥接对照实验，
这代表未来韩国的疫苗不须招募大量的受试者进行第三期对照实验。
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.
韩国食药署周三宣布，修改第三期实验的指导方针来加快国产疫苗开发。
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.
修改后只需要4,000名受试者就可以了。(对照台湾，高端扩大二期收案数=3,700)
Cross-platform comparisons between already authorized vaccines and a
candidate of a different type are also allowed.
允许与现有的疫苗进行免疫桥接对照比较。
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.
这段讲的是韩国选择的DNA疫苗技术，世界上没有同样技术的疫苗可以比较。
(台湾键盘疫苗专家乡民：为什么不选腺病毒跟mRNA呢? 干嘛不学中国做减毒呢?)
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.
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
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.
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，主要是韩国政府希望帮国产疫苗厂商减少开支。
(台湾乡民：叭叭叭叭!!炒股!!图利!!割韭菜!!!)
BTW其实日本也快通过免疫桥接取代原本的大规模收案的三期了，
台湾有没有领先世界窝补知道，但一定是领先日韩的，
至于他们的国民有没有跳出来说政府屠杀人民或割韭菜，我就不知道了，
等各位国际观满分的八卦版乡民教育我。