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| Joonwook Kwon, Deputy Head of Defense Countermeasures Headquarters./News1 © News1 Reporter Jang Sooyoung |
The government expressed its willingness to complete the development of a ‘Corona 19’ domestic treatment and vaccine. The goal is to complete the development of the treatment within this year and the vaccine by 2021. Even if it is not the first approved product in the world, the government’s position is to actively respond to the next new infectious disease through the infrastructure of I + D that is being built this time.
Jun-wook Kwon, deputy director of the Central Defense Countermeasures Headquarters, said in a regular briefing on the afternoon of the 17th: “We are striving to get approval for domestic treatments this year and domestic vaccines next.” You can play the game and you can have room for general quarantine measures, ”he said.
Deputy CEO Kwon added: “Even if we are not the first in the world, we will surely ensure R&D expertise, clinical trials and cooperation between industry and academia by taking a step, step by step, as if we were taking our first steps at a glance “.
Deputy CEO Kwon said: “With Corona 19 as an opportunity, the investments, interests and achievements in fields like treatments and vaccines continue, and as many talents, students and researchers study related fields, and there are many experts in trials. clinicians, if the system is established, you will have it ”, he emphasized.
Assistant General Manager Kwon said: “I have said that next year will be different from this year,” he said. “We will do everything we can to protect people to the end with our own research and development for the new infectious disease after Corona 19.”
Celltrion and GC Green Cross are currently receiving government support among national ‘Corona 19’ treatment companies.
Celltrion received approval for phase 2 and 3 clinical trials for the antibody therapeutic substance ‘CT-P59’ on September 17 and is in clinical trials. It is intended for patients with mild to moderate severity. Celltrion plans to apply for emergency approval within this year if it receives an efficacy and safety approval rating in phase 2 clinical trials. Additionally, on day 8 it was approved for phase 3 clinical trials for preventive purposes. This is a clinical trial to confirm the preventive effect of ‘Corona 19’ directed to the contact of the confirmed patient.
GC Green Cross was approved for phase 2 clinical trials for the blood system drug ‘GC5131A’ in August and is currently in clinical trials. A blood system drug is made by extracting an immunogenic antibody from plasma for a cure for COVID-19. Due to the nature of the formulation, it can only be produced while the curing plasma for Corona 19 is secured.
GC Green Cross completed production of the second batch of ‘GC5131A’ on Day 14. Unlike the first batch produced for clinical trial purposes, this production is intended for the “treatment” of actual confirmed patients in the medical field. The plasma produced this time is 240 liters, about four times more than the input from the first batch. Drugs in clinical trials can be used for patients who are in danger of death or who do not have alternative treatment options under the approval of the Ministry of Food and Drug Safety.
SK Bioscience, Genexine and Jinwon Life Science are launching into the development of the domestic vaccine ‘Corona 19’.
SK Biosciences requested a phase 1 clinical trial from the Ministry of Food and Drug Safety earlier this month for a synthetic antigen vaccine manufactured by genetic recombination. Genexine is in phase 1 clinical trials for ‘GX-19’, a DNA vaccine. The results of Phase 1 are expected to come out within this year. Jinwon Life Sciences is also conducting clinical trials of the ‘GLS-5310’ DNA vaccine.
Then, on the 17th, in a periodic briefing at the Central Defense Countermeasures Headquarters, interviews with Joon-wook Kwon, Deputy Head of the Central Defense Countermeasures Headquarters.
-Gilead Sciences published a study that showed remdesivir reduced the case fatality rate by 70%, and also explained that it can be interpreted as ‘there is a case-fatality reduction effect,’ said the head of the patient management team , Kwak Jin, Dae-bon Bang.
This contradicts the World Health Organization (WHO) findings that remdesivir does not reduce the death rate. What research findings should be trusted?
▶ Regarding Remdesivir, a final report has already been published in the New England Journal of Medicine. It has already been reported that the length of hospital stay is statistically significantly reduced through clinical trials, and that the case fatality rate is reduced to some extent, although there is no statistical significance in the field of reducing the rate of lethality.
Based on these contents, the treatment guidelines related to the treatment of patients with COVID-19, focused on the Central Clinical Committee of Korea, have already been distributed and (treatment) in progress.
If you look at the content of the research done by the World Health Organization this time, it will be published as an article soon, so there will be additional expert reviews.
This WHO-led study conducted experiments and evaluations on four types of therapeutic drugs with a population of 13,000 at nearly 500 medical institutions in about 30 countries around the world. As a final expert review is still needed, it is felt that there is no need to change or improve home treatment guidelines.
In this regard, there was an urgent discussion with the experts of the Central Clinical Committee, and there were opinions of national experts that it is necessary to review sufficiently if the study was carried out in an adequate and elaborate manner according to the design because it was a study that involved many countries in a considerable number of regions.
▶ (Seo Kyung-won, Director of Drug Review, Ministry of Food and Drug Safety) The national approval of Remdesivir is based on clinical results conducted by the National Institutes of Health (NIH). According to the NIH study, the recovery period was shortened by 5 days from 15 to 10 days in seriously ill patients. In seriously ill patients, approval was granted because it was of significant clinical importance.
The NIH trial also did not reduce the actual death rate. Therefore, the part where “there was no difference in death rate” announced in the WHO clinical trial is not very different from previous clinical trials (results).
Remdesivir is currently licensed only for critically ill patients who need oxygen. WHO clinical results are in a situation where peer review has not been completed, and we plan to thoroughly review the target patient, regional medical environment, test methods and results, etc. after completing the peer review. Until now, you can use it according to the expert’s judgment based on your permission.
-I am curious if remdesivir should continue to be used to treat COVID-19 patients even if it cannot reduce the death rate. Does it help prevent symptoms in mild patients?
▶ The comment of the WHO Secretary-General is also very heavy and, if you look closely, the effect is minimal or null even during the hospital stay in this clinical trial.
The study looked at the mortality rate, the length of hospitalization, and whether it delayed the start of respiratory use, and the WHO Secretary-General’s comments were very strong in this regard. Regarding the quarantine authority, anyway, the content published in the article must be reviewed by experts. If there are any changes to the domestic and foreign guidelines or experts, we will carefully review them once more.
▶ (Seo Kyung-won, Director of Drug Review, Ministry of Food and Drug Safety) Currently, remdesivir is only used for seriously ill patients who need oxygen assistance, so it is not used for patients with mild or moderate illnesses .
▶ Recently, in the United States, combination therapy, that is, using other immunomodulators with remdesivir to see the therapeutic effect, we know that the results will come sooner or later. In this sense, a national clinical trial is planned in which remdesivir and other treatments with high potential for effectiveness are combined.
-Have there been any side effects related to remdesivir administration in Korea?
▶ (Seo Kyung-won, Director of Drug Review, Ministry of Food and Pharmaceutical Safety) So far, there have been 11 cases of adverse reactions related to remdesivir administration. This is a known side effect in clinical practice. There have been no significant or dangerous side effects to date.
▶ Regarding side effects, the latest New England Journal of Medicine report showed that side effects were less than placebo (remdesivir group).
-Today, there was a case of group infection of caregivers, patients and guardians at SRC Rehabilitation Hospital in Gwangju, Gyeonggi-do. How many is the number of test subjects, such as the number of confirmed patients and contacts? Also, what are the risk factors that have been transmitted in the facility?
▶ More details will be explained through the following information sessions. As a result of the current situation, a total of 244 people were tested and 32 confirmed cases were found, more than the 12 statistics at noon today. It is presumed that the infection started through the workers.
What the quarantine authorities emphasized is that the connection between the silent spread of the local community and the radio waves of asymptomatic or mildly confirmed cases explodes in nursing homes, nursing homes, rehabilitation hospitals and psychiatric hospitals, as well as the terminal station.
The reason is that there are patients who cannot move well for a long period of time here, and the characteristics of the patients themselves are elderly and most have underlying diseases, so explosive (infection) is likely to occur.
A large-scale screening for high-risk groups to detect confirmed cases at once is scheduled to begin next week.
-In regards to the group infection in Gwangju Rehabilitation Hospital, Gyeonggi-do, it seems that there is a nursing hospital in the same place. Is there a separate building or are there any concerns about the occurrence of additional confirmed cases here?
▶ Regarding this part, we will verify the risk by an on-site check. The most worrying thing is if there are people who work in crossovers. The building itself is being used separately, but we are confirming it for now, but it is connected at a very close distance, so we will do a detailed investigation.
-Group infections continue, centered on hospitals such as Busan, Gyeonggi Uijeongbu and Gyeonggi Goyang. How does Bang Dae-bon diagnose this?
▶ You are looking very seriously. One of the goals of quarantine measures is to reduce the death rate. It is a very painful part for the quarantine authorities that the medium to medium calm spread continues and eventually (group infection) occurs in the hospitals corresponding to the destination area.
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