[의학신문·일간보사=이재원 기자] While five companies (SK Bioscience, Celid, Genexin, Ubiologics, Genewon Life Sciences) that have entered into the COVID-19 vaccine development have talked about the difficulties in phase 3 clinical trials, the government has the possibility of success in the case of funding for phase 3 clinical trials. He delivered a policy of intensive support by selecting a vaccine that is available.
In addition, regarding the review of the ICP permit system and establishment of the ICP proposed by SK Bioscience and the like, the WHO and CEPI policies are in motion and are watching their trends.
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In addition, Democratic Party lawmakers Shin Hyun-young and Lee Kwang-jae held a discussion on’Conversation with the Future, the Road to a Corona Clean Country: Domestic Vaccine Roadmap, Corona 19 Vaccine Sovereignty’ on and offline on the 2nd.
In this debate, officials from five domestic companies in the process of developing a Corona 19 vaccine participated, clarifying the characteristics and development roadmap of each company, and explaining the difficulties and responses to the Corona 19 mutation.
SK Bioscience and Ubiologics are developing protein-based vaccines, Celid is developing adenovirus vector-based vaccines, and Genexine is developing vaccines using DNA-based technology, respectively.
All five companies are undergoing clinical trials, and they announced that they are planning a phase 3 clinical trial based on the clinical results currently in progress after 2021 or 2022.
As for the difficulties related to vaccine development, the five companies cited the issue of review of the Immunogenicity (Immune Correlate of Protection, ICP) approval system and the presentation of guidelines by the Ministry of Food and Drug Safety, and the cost of phase 3 clinical trials. Also, the need for an integrated system for the IRB system was mentioned.
“Three difficulties can be said,” said Lee Sang-mok, head of the strategic planning division of SK Bioscience. “If you conduct a clinical trial with a comparative clinical study, it is not only economically beneficial, but also the clinical period can be shortened.”
Lee added, “I would like the Ministry of Food and Drug Safety to review the approval system for this as currently being reviewed by WHO.”
Selid’s CEO Kang Chang-yul also said, “After conducting a clinical trial and comparing and analyzing the immune response induced by a foreign vaccine, the method of obtaining approval by proving non-inferiority. If a foreign vaccine comes in, we compared it with our clinical trial group and conducted a blind test. Through this, we are considering permitting by proving non-inferiority.”
According to Kang, the coronavirus infection rate in Korea is low, so it is difficult to perform phase 3 clinical trials using traditional methods. Therefore, it would be desirable for the state to authorize and establish an agenda using the aforementioned method, Kang explained.
Genexine’s research center director Woo Jung-won pointed out the cost issue of the third phase. “Unlike phases 1 and 2, the cost of phase 3 clinically is enormous,” said Woo. “If you target 30,000 people, it will cost nearly 200 billion won. The cost for this is a problem.”
In addition, Baek Young-ok, CEO of UBiologics, also reviewed the ICP approval system through comparative clinical trials, and Jung Moon-seop, head of Jinwon Life Sciences Research Institute, stressed the need for government funding.
Regarding this, Mok Hyeon-sang, head of the new drug development project of the ministry said, “Although he is aware of the difficulties in the burden of the cost of phase 3 clinical trials, the government will select and focus on the Korean-developed Corona 19 vaccine with a high probability of success.
“The budget received from the National Assembly this year in 2021 is the clinical budget for vaccine support of 68 billion won. If you divide this into five companies, the cost will be very short,” he said. “In the case of the three clinical trials, it will cost from 100 billion to 500 billion won, as the five companies said earlier.”
He added, “As a result of discussions with the Prime Minister and the pan-governmental committee, there is a stance that the five companies have to choose and provide intensive support for the vaccines with high probability of success.
In particular, it was announced that it can also support global phase 3 clinical trials for vaccines with particularly good results among domestically developed vaccines.
In addition, the IRB pointed out that when various clinical consignment institutions participate, they must receive it separately, and the standards are different. Explained that it is being promoted. However, in the case of mutually recognized IRB, he said that it has not yet come up with a solution.
Academia and the government also agree on the review of the immune contrast indicator, defense performance correlation coefficient, and the ICP permit screening system, he said, but it is difficult to make ICP immune contrast indicators in a small-scale manner, and it is difficult to make them independently in Korea. .
Director Mook said, “Since moving in the Gates Foundation and CEPI, ICP is expected to be settled at a faster time.”