[과학]Who is the clinical cost of 2-3 billion won?…Immune Representative Indicator (ICP) promotion

[앵커]

The final gateway to commercialization of domestic vaccines is a phase 3 clinical trial that verifies efficacy and safety on a large scale.
This is because it costs about 200 to 300 billion won as it is conducted for tens of thousands of people, and it is very difficult to select test subjects.

This is Lee Hye-ri.

[기자]

It is a vaccine developer that was approved for both phase 1 and phase 2 clinical trials by the Ministry of Food and Drug Safety in January this year.

I just entered the phase 1 exam, but I’m already worried about the phase 3 exam.

In Korea, where the quarantine is relatively excellent, it is not easy to distinguish whether test subjects do not get Corona 19 due to the vaccine effect or whether it is due to quarantine.

[백영옥 / 유바이오로직스 대표이사 : 상대적으로 미국, 브라질, 남아공은 자연 발생 확률이 높으니깐 거기서 임상을 했을 때 백신의 효과에 의해서 발병 안 되는 사람, 백신의 효과가 아닌 사람을 (구별해) 백신 효과를 검증하기 쉬운 거죠.]

The cost of the exam is also a big problem.

It is estimated that it will cost more than 200 billion won for 30,000 to 40,000 people in the domestic and international phase 3 test.

However, the government subsidy is only 68 billion won, and even if it is divided into five companies that have started developing vaccines, the amount of support is smaller.

Therefore, rather than a large-scale phase 3 clinical trial, the immune surrogate indicator (ICP) method, which recognizes the efficacy of a vaccine based on the level of neutralizing antibodies of an already approved overseas vaccine, is being discussed as an alternative.

[성백린 / 백신실용화기술개발사업단 단장 : 기존의 나와 있는 백신 대비 우리가 만든 백신이 면역가, 항체가가 어느 정도 되는지를 가지고 백신 효능을 간접적으로 측정할 수 있어 훨씬 간편한 방법입니다.]

The immune proxy method targets 1,000 to 2,000 people and costs 30 to 40 billion won to complete the phase 3 clinical trial and the period is shortened.

The World Health Organization and WHO are also discussing the method of immune representatives for rapid vaccine approval with the emergence of the mutant virus.

The government also plans to strengthen cooperation with the international community to quickly establish and utilize immune representative indicators.

This is Hyeri Lee from YTN Science.

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]