[Press Release, Dec 31, 2020] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
- Registration Date 2021-01-07
- Hit 1044
[Press Release, Dec 31, 2020 / unofficial translation ] * Revised translation posted at 2:30pm on Jan. 7, 2021.
COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
- 21 COVID-19 therapeutics and vaccines in clinical trials in Korea -
□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted approval, on Dec. 31, for the clinical trial of GBP510, a vaccine developed by SK Bioscience in Korea.
○ A total of 15 drugs (13 APIs) and 6 vaccines, approved for COVID-19-related clinical trials, are currently under development in Korea.
□ The clinical trial of SK Bioscience’s vaccine is conducted in healthy adults to evaluate the safety and immunogenicity* of GBP510. Phase II clinical trial will follow after the completion of Phase I.
* immunogenicity : the increase rate of neutralizing antibody titer, which will eliminate or reduce virus infectivity
○ GBP510 is a recombinant vaccine that contains coronavirus’ surface antigen produced through recombinant technology.
- The infection prevention mechanism is that the surface antigen of the vaccine triggers immune response by stimulating the immune cells to produce neutralizing antibodies. The antibodies, in turn, destroy the coronavirus when it enters the human body.
- SK Bioscience also received MFDS approval for Phase I trial of a recombinant vaccine, NBP2001, on Nov. 23. NBP2001 induces immune response using the coronavirus’s surface antigen, whereas GBP510 uses the surface antigen that binds to a specific protein that forms a nanostructure (icosahedron).
○ Pharmaceutical companies across the world are also conducting clinical trials of COVID-19 vaccines that use recombinant technology. (e.g. Novavax in the U.S.: Phase III)
□ Mindful of the heightened public interest in the development of COVID-19 treatments and vaccines, MFDS will continue to promptly provide updates on the clinical trials of such products.
○ The Ministry will also make every effort to ensure appropriate access to treatment options for the Korean people by providing necessary assistance to accelerate the development of safe and effective COVID-19 treatments and vaccines.
For more information, please find the Press Release on Dec. 31, 2020 in Korean.
COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
- 21 COVID-19 therapeutics and vaccines in clinical trials in Korea -
□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted approval, on Dec. 31, for the clinical trial of GBP510, a vaccine developed by SK Bioscience in Korea.
○ A total of 15 drugs (13 APIs) and 6 vaccines, approved for COVID-19-related clinical trials, are currently under development in Korea.
□ The clinical trial of SK Bioscience’s vaccine is conducted in healthy adults to evaluate the safety and immunogenicity* of GBP510. Phase II clinical trial will follow after the completion of Phase I.
* immunogenicity : the increase rate of neutralizing antibody titer, which will eliminate or reduce virus infectivity
○ GBP510 is a recombinant vaccine that contains coronavirus’ surface antigen produced through recombinant technology.
- The infection prevention mechanism is that the surface antigen of the vaccine triggers immune response by stimulating the immune cells to produce neutralizing antibodies. The antibodies, in turn, destroy the coronavirus when it enters the human body.
- SK Bioscience also received MFDS approval for Phase I trial of a recombinant vaccine, NBP2001, on Nov. 23. NBP2001 induces immune response using the coronavirus’s surface antigen, whereas GBP510 uses the surface antigen that binds to a specific protein that forms a nanostructure (icosahedron).
○ Pharmaceutical companies across the world are also conducting clinical trials of COVID-19 vaccines that use recombinant technology. (e.g. Novavax in the U.S.: Phase III)
□ Mindful of the heightened public interest in the development of COVID-19 treatments and vaccines, MFDS will continue to promptly provide updates on the clinical trials of such products.
○ The Ministry will also make every effort to ensure appropriate access to treatment options for the Korean people by providing necessary assistance to accelerate the development of safe and effective COVID-19 treatments and vaccines.
For more information, please find the Press Release on Dec. 31, 2020 in Korean.
Division 국제협력담당관
Written by 배성명
Telephone 043-719-1559