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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。


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)

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。

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?)

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。

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BTW 我猜這篇會被噓到XX

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