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 ~
--
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 ~
--
All Comments