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The clinical trial of ‘GBP510 (SK Bioscience Co., Ltd.)’, a Corona 19 vaccine developed in Korea, was approved on December 31st.
The Ministry of Food and Drug Safety (Director Kang-rip Kim, hereinafter the Ministry of Food and Drug Safety) said that the drugs currently being developed with approval for a Corona 19-related clinical trial in Korea are 15 products. for treatment (13 components) and 6 products for vaccines.
This clinical trial aims to evaluate the safety and immunogenicity of ‘GBP510’ in healthy adults. Phase 1 is followed by Phase 2 in sequence. Immunogenicity refers to the rate of increase of “neutralizing antibodies” that eliminates or reduces viral infectivity.
‘GBP510’ is a ‘combination vaccine’ made using genetic recombination technology of the ‘surface antigenic protein’ of Corona 19 virus.
The prevention principle is that the vaccine surface antigen protein stimulates immune cells to form neutralizing antibodies to induce an immune response, and when corona virus 19 invades, the antibody kills corona virus 19.
For reference, the recombinant vaccine ‘NBP2001’, which was clinically approved on November 23 by SK Bioscience (Phase 1), induces an immune response with the Corona 19 virus surface antigen protein, and ‘GBP510’ is a surface antigen that has a nanostructure. There is a difference in the induction of an immune response by binding to a specific protein that forms the icosahedron).
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For reference, when looking at clinically approved national vaccine types, DNA vaccines (3 cases) are △ International Vaccine Research Institute (INO-4800 Phase 1-2 △ Genexine (GX-19N) Phase 1-2 △ Genwon Life Science (GLS-5310)) Phase 1-2, etc. Recombinant vaccines (2 cases) are △ SK Bioscience (NBP2001) Phase 1 △ SK Bioscience (GBP510) monophasic, etc. And the viral vector vaccine (1 case) is △ Celid (AdCLD) -CoV19) 1-2 phases.
Overseas, clinical trials of the COVID-19 vaccine are underway using genetic recombination technology. (3rd prize from Nova Bax, USA)
The Ministry of Food and Pharmaceutical Safety announced that it will promptly provide information on the status of the clinical trials of the developed product, taking into account the great interest of the public in the development of the COVID-19 treatment and vaccine.
Furthermore, we plan to do everything possible to ensure that the Korean people receive treatment opportunities by providing the necessary support so that safe and effective COVID-19 treatments and vaccines can be developed rapidly. Reporter Kang Kyung-nam
