How far did you come to develop a cure-vaccine?
See also the desire for the development of drugs and vaccines to radically end the Corona 19 virus, as patients with the new coronavirus infection (Corona 19) reach 2.5 million people worldwide. As the process of developing drugs, centered on biotech companies and global pharmaceutical companies, is accelerating, there are expectations that drugs and vaccines will be released in the near future. However, it is only an “optical illusion” that is owed by frequent interim scepnoties, announcements, and the desire of the public, and it still takes time to develop treatments and vaccines. Experts point out that because safety is a top priority, drugs and vaccines should be properly tested and released after more time, so they won’t ‘poison the body’.

According to the Database of Clinical Trials operated by the National Institutes of Health (NIH) Medical Library, there are 692 clinical trials conducted worldwide in connection with Corona 19 and Sars-CoV-2, which cause Corona 19. According to a paper published in the Journal of the American Association of American History (JAMA) on 14 March by a team of professors at the University of Texas School of Medicine, 109 of these are classified as clinical trials involving therapeutics that are actually recruiting patients or conducting trials.

Most of these are using a “drug re-creation” strategy that is re-clinical for corona 19 by changing the use of existing drugs or candidates. It is a shortcut strategy taken to find candidates in a white state, taking an average of more than 10 years. Remdesivir, a malaria drug therapy chloroquine and hydroxy chloroquine, AIDS drug Caletra, hepatitis C drug ribavirin, etc., which were finally eliminated as a candidate for Ebola treatment, are either undergoing clinical or are planning a clinical trial.

However, given the “intermediate score card” of these candidates, remdesibir is almost the only candidate for the treatment that can be expected at present. Cell experiments have confirmed the effect of reducing the corona19 virus by dosing small amounts. It was effective even if only a low concentration of one-eighth of the competitor hydroxy chloroquine and about one-third of the chloroquine. On November 11, the American Journal of Medicine (NEJM) published a report that confirmed the effect of improving symptoms as a result of dosing the drug on to severe respiratory patients. However, it is necessary to have more rigorous large-scale clinical trial results, such as comparing them to the Treaty of Great Treats.
Chloroquine and hydroxy chloroquine are the drugs recommended by U.S. President Donald Trump. Block the fusion of cell membranes during virus penetration, or block the virus proliferation on the principle of blocking the internal membrane formation process for virus replication. A team of researchers from China and France confirmed symptom relief and reduced virus in corona19 patients who took the drug. However, it is not a rigorous clinical trial and requires a clinical process. There is also a side effect of the increase in the dosing concentration is being administered at a low concentration in the country. Kaletra and Ribavirin, on the other hand, were weak in effectiveness and side effects were so concerned about the “fallout” that they appeared to be “discouraged.” Caletra was presented to NEJM in March by a Chinese research team to 199 patients, but the effect was minimal. Ribavirin was also partially viral removal effect in sars (SARS, severe acute respiratory syndrome) patients studies showed side effects such as elevated liver levels and hemolytic anemia.

In Korea, research is being conducted mainly on candidates who have avoided fallout. “In Korea, studies comparing lemdesivir and hydroxy chloroquine, comparing caletra and hydroxy chloroquine, and studies of administering hydroxychloroquine before the onset will be conducted,” said The Director of the Center for Infectious Disease Research at the National Central Medical Center.

However, unlike the drug that more than 100 clinical treatments are underway, vaccines are a longer way to go. According to a report published by the World Health Organization (WHO) on 20 March (local time), only five vaccines are under development in the United States and China. The National Institute of Allergy and Infectious Diseases (NIAID) and The American Biotechnology Company Modena last month 16 days to develop a genetic material ribonucleic acid (RNA) based vaccine started clinical phase 1, the Chinese Military Academy of Sciences and biotechnology company Cansino is experimenting with a method (viral vector) to inject into the human body by inserting the target gene using another viral genome like a courier box. Innovio in the United States has developed a vaccine that injects DNA to produce antigens in the body and is being clinically triald in the United States for 40 people since the beginning of this month. Innovio plans to conduct clinical trials in Korea with the International Vaccine Research Institute (IVI) and the National Instituteof Health. These are all clinical phase 1 phases to determine the toxicity and dosing concentration. IVI Secretary General Jerome Kim said in a report in late March, “It only takes 12-18 months to determine which vaccines will be effective even if clinical trials are abbreviated, and additional time for production is needed.”

Korean pharmaceutical biotech companies, with government support, have been engaged in a series of battles to develop corona 19 drugs and vaccines. According to the Korea Pharmaceutical Bio-Association on 21 August, 18 places in Korea have officially entered into the development of drugs and vaccines. Celltrion, SK Biosciences, GC Green Cross, Boryeong Biopharma and other major korean companies range from bioventures.

The reaction of the market is hot, as the stock market fluctuates every time domestic pharmaceutical biotech companies come up with news of new developments. However, it takes a lot of time to develop a real drug and vaccine in Korea. The Food and Drug Administration has applied for a clinical trial plan (IND) for the development of corona 19 drugs, but only the domestic companies that have been licensed to date have been sanctioned. The use of the hepatitis B drug rebovir, which was released in 2007, was approved for clinical phase 2.

YimmEd, a domestic bio-venture, is also planning to enter clinical phase 2 by July after completing clinical phase 1 with a test report later this month. Hepatitis B is a situation in which you have applied for a test plan for the drug as a candidate for a drug treatment. AptaBio is pursuing phase 2 clinical trials by replacing the APX-115, which is being developed as a treatment for diabetic complications, for Corona 19. As a drug that interferes with the process of creating free radicals during virus intrusion in the body, went through the clinical phase 1 confirmed the antiviral effect of about one-third of remdesivir in cell experiments. In the case of other companies, most of the cases have been applied for IND at the food and drug agency, but receive a requirement to supplement the data, or stay in the candidate development stage.

Vaccines are centered on companies with existing vaccine development capabilities, such as GC Green Cross and SK Biosciences. Xenexin, along with KAIST, revealed that it was developing a DNA vaccine with the aim of starting clinical trials in June. However, all of them are currently in the preclinical stage.

Although the big global pharmaceutical companies are pushing ahead with the development of drugs and vaccines to domestic bioventures, it is not yet possible to come up with such a result is that there is a lack of research on the new virus, because it requires physical time to ensure safety. Kim Sung-jun, head of the Korea Chemical Research Institute’s New Swine Virus (CEVI) Fusion Research Team, said, “Unlike the MERS (MERS, Middle East Respiratory Syndrome) virus, which kills cells in two or three days when infected with human cells in the laboratory, Sascoronavirus-2 has other characteristics, such as maintaining an infection without killing cells even if it infects more than a week.” “Knowing the characteristics of the virus can make the right cure and vaccine, but if there are side effects that make the drug or vaccine too hasty, it is not a vaccine, but rather a poison vaccination.” Park Hye-sook, professor at Ewha Women’s University School of Medicine, pointed out, “The people must understand that while corona19 drugs and vaccines are very urgent, it takes time to demonstrate safety and efficacy and put them to practical use.”

Even if no cures and vaccines can be developed within the year, experts argue that there is plenty of reason to continue to work on development. This is because the Corona 19 situation is likely to be prolonged and will help to establish a seriousness to respond to the second and third Corona 19, which may be out of action over the years. Kim Sung-jun said, “The rapid development of vaccines by U.S. companies Inobio and Modena, and others, allowed us to start clinical trials with prompt approval from the U.S. Food and Drug Administration (FDA) because we had a vaccine development platform when Mers was created in 2015.”

Yun Shin-young, Reporter, Dong-ashilla@donga.com

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