Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release, Dec 31, 2020] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
  • Registration Date 2021-01-07
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[Press Release, Dec 31, 2020 / unofficial translation ]


COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
- 21 COVID-19 therapeutics and vaccines under clinical trial 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.
○ 15 drugs (13 APIs) and 6 vaccines under development have received the approval for COVID-19-related clinical trials 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 rate at which the amount of neutralizing antibodies that removes or reduces virus infectivity increases.

○ GBP510 is a recombinant vaccine made of coronavirus’ surface antigen produced through genetic recombination technology.
- In terms of the infection prevention mechanism, the surface antigen of the vaccine triggers immune response by stimulating the immune cell to produce neutralizing antibodies. In turn, the antibodies 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 surface antigen that binds with a specific protein that forms a nanostructure (icosahedron).


< Vaccines approved for clinical trial in Korea >

Vaccine Types

Sponsor (product name)

Clinical Trial Phase

DNA vaccine (3)

International Vaccine Institute (INO-4800)

I/II

Genexine (GX-19N)

I/II

GeneOne Life Science (GLS-5310)

I/II


Recombinant vaccine (2)

SK Bioscience (NBP2001)

I

SK Bioscience (GBP510)

I/II

Viral vector vaccine (1)

Cellid(AdCLD-CoV19)

I/II


○ Pharmaceutical companies across the world are conducting clinical trials of COVID-19 vaccines that use genetic recombination 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 that the people of Korea receive treatments by providing the necessary assistance in the swift development of safe and effective COVID-19 treatments and vaccines.


For more information, please find the Press Relase on Dec. 31, 2020 in Korean.

Attached File
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