SK Bioscience's vaccine candidate allowed to go ahead with third-stage clinical trials

By Lim Chang-won Posted : August 10, 2021, 16:06 Updated : August 10, 2021, 17:17

[Courtesy of SK Bioscience]

SEOUL -- A COVID-19 vaccine candidate codenamed GBP510 being developed by SK Bioscience was allowed to go ahead with third-stage clinical trials that will be carried out simultaneously in South Korea, Southeast Asia and Eastern Europe.

GBP510 is South Korea's first vaccine candidate to receive state permission for Phase 3 clinical trials and the second in the world to demonstrate its effectiveness in comparison with licensed vaccines, the Ministry of Food and Drug Safety said in a statement on August 10. The ministry hailed the approval of clinical trials as the first step toward vaccine sovereignty.

GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus made using genetic recombination technology to induce an immune response. This vaccine has been developed to enhance immune effects by generating antibodies by utilizing techniques that increase antigen exposure.

GBP510 will be used for 3,000 people aged 18 or older and a comparative vaccine produced by AstraZeneca PLC, a Swedish-British pharmaceutical company, for 990 others. SK Bioscience has a production partnership with AstraZeneca PLC.

A comparative approach was adopted as it is difficult to proceed with clinical trials using the existing method that requires tens of thousands of test subjects to evaluate the validity and safety of test vaccines, the ministry said, adding that although phase 2 clinical trials have yet to be completed, GBP510 showed sufficient safety and immunogenicity, no special side effects have been reported.

The development of GBP510 has been funded by the Coalition for Epidemic Preparedness Innovations (CEPI), an international foundation that finances vaccine research projects. The project involves the Institute for Protein Design at the University of Washington in Seattle.

CEPI has launched a Wave 2 project to discover new vaccines with money from the Bill & Melinda Gates Foundation. The project is aimed at finding universal and economical candidate materials that are easy to store and improve the number of inoculations, productivity and immune response. When development makes progress, SK Bioscience would carry out research into "booster shots," which are additionally inoculated with vaccines, and multi-vaccines that prevent more than one type of virus.
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