韓國 - 棒球閒聊

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.

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.

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.

Cross-platform comparisons between already authorized vaccines and
a candidate of a different type are also allowed.

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.

http://www.koreaherald.com/view.php?ud=20210630001048


韓國為了加速國產疫苗的進程 FDA已核准免疫橋接取代傳統三期

而且不限於同種疫苗間的比較 所以韓產的DNA疫苗亦可和現有疫苗比較


再次打臉一堆以為只有自己說的是科學的偽科學仔 ~

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