※ 引述《permoon (有志难伸优质写手ㄉㄉ)》之铭言：
: 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, accordin
g
: 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。
我就问一句
二期解盲过了吗？
二期解盲没过就要硬上
系勒冲三小
干 别人的囝仔死袂了