The Ministry of Food and Drug Safety of South Korea periodically discloses the status of vaccines produced in Korea. According to the Ministry of Food and Drug Safety, the clinical trials related to the Corona19 vaccine approved as of December 2020 are “INO-4800” by the International Vaccine Institute (IVI), “GX-19/GX-19N”, “GLS-5310” by Zinwon Life Sciences, and “AdCLD-CoV19” by Cellid and “NBP2001” by SK Bioscience.
The vaccine by IVI was approved for the first time in Korea on June 2. As a candidate material for the Corona19 vaccine developed by INOVIO, a U.S. bio company, the International Federation for Transmission Against Diseases (CEPI) provided research funds and the International Vaccine Research Institute commissioned clinical trials in Korea. This vaccine is a DNA vaccine. DNA vaccines first put nucleic acids into the body to make antigens. These antigens induce immune responses. This method is widely studied because it can be made quickly and is safe if you know genome information. Currently, the vaccine is being evaluated by 40 healthy adults aged 19 to 50 at Bundang Seoul National University Hospital, Seoul National University Hospital, and the International Vaccine Research Institute.
The vaccine developed by Genexin was approved for a 1/2a phase clinical trial on June 11 as a DNA vaccine. Yonsei University Severance Hospital and Gangnam Severance Hospital are conducting clinical trials. After clinical trials of administering two doses of candidate substances to 40 adults, the company is evaluating the safety and antibody formation effectiveness of 150 people, including placebo groups, with one dose in phase 2a. On December 17th, the results of the first phase of clinical trials were announced, showing antigen-specific T-cell immune responses higher than recovery patients in terms of immunogenicity. There were a few side effects of systemic or severity abnormalities, and mild adverse reactions were also less frequent within 5%.
Genexin is also changing the candidate material for the Corona 19 vaccine from the existing GX-19 to GX-19N and is proceeding with clinical trials again with new vaccine candidate material. The move is aimed at preparing for the outbreak of mutagenesis and re-infection of the newly emerging coronavirus.
The vaccine from Jinwon Bioscience and Cellid was approved for clinical trials in early December and is undergoing clinical trials. The Jinwon Life Science vaccine is also a DNA vaccine. It will check the safety, optimal capacity, and inoculation interval of the GLS-5310 for 45 healthy adults at Guro Hospital of Korea University. It will evaluate the safety and effectiveness of the GLS-5310 in the placebo and double blindfolded ways for 300 healthy adults.
Cellid’s vaccine is a “viral vector vaccine” manufactured from the surface antigen gene of the coronavirus in an adenovirus mold. Clinical trials will be conducted at Gangnam Sungsim Hospital of Hallym University, Guro Hospital of Korea University, and Ansan Hospital of Korea University. In the first phase, 30 healthy adults will be evaluated for safety and immunity, and 120 people will be evaluated for additional safety and immunity in the second phase. Cellid conducted a full-time wound on crab monkeys on the 16th and found that all of the infectious corona 19 had disappeared from the upper airway, the main infection site, on the second day after being infected with the coronavirus.
SK Bioscience’s vaccine is a recombinant protein vaccine. It is a method of making a piece of viral protein and injecting it into the human body with an antigen. When the actual virus breaks in, immune cells attack the viral protein, which is similar to this antigen protein. It received approval from the Ministry of Food and Drug Safety for the first prize on the 24th of last month. Seoul National University Hospital and Seoul National University Bundang Hospital evaluate the safety, weakness, and immunization of vaccines for healthy adults aged 19-55. To this end, clinical trials will be conducted on the first prize of blindfolding observers, random assignment, and placebo comparison.
In the briefing on the securing of vaccines held on the 18th of this month, Lim Intaek, director-general of the Ministry of Health and Welfare, said, “It is true that the domestic Corona 19 vaccine is slower in development than overseas vaccines, and we expect it to end late next year or early next year.” Even if a vaccine is developed, considering the licensing process and the establishment of a distribution environment, it is inevitable that we will have to rely on overseas vaccines for a while until a domestic vaccine is inoculated.