By Baek Byung-yeul
SK Bioscience is set to conduct Phase 3 clinical trials of its COVID-19 vaccine in overseas countries to check its effectiveness as a booster shot. The biotech company also expects its vaccine could be approved by a health agency here, according to a company official, Monday.
The biotech arm of SK Group and the International Vaccine Institute (IVI) said they will begin global Phase 3 clinical trials of SK's COVID-19 vaccine candidate GBP510 in Thailand, Nepal and Columbia. SK has been collaborating with the IVI for the development of a Korea-made COVID-19 vaccine.
In Thailand, the clinical trials will be conducted on adults who have been vaccinated twice with GBP510 or other COVID-19 vaccines. In Nepal and Colombia, the booster shot effects of GBP510 will be checked for adults who have been vaccinated twice with other companies' COVID-19 vaccines.
In April, SK Bioscience received approval by the Ministry of Food and Drug Safety for Phase 3 clinical trials to confirm the effectiveness of the GBP510 as a booster shot. Booster shots are performed on people who have been vaccinated twice to evaluate immunogenicity and safety.
The company claims GBP510 is a COVID-19 vaccine that improves the immune response through booster shots and is expected to be sufficiently safe.
The company submitted a biologics license application to the Ministry of Food and Drug Safety and is waiting for approval of GBP510. If approved, it will be the first domestically developed COVID-19 vaccine.
"We expect approval to be available within the first half of this year," a company spokesman said.
The company has said it plans to complete the approval of its COVID-19 vaccine candidate GBP510 from the U.K., Europe and the World Health Organization (WHO) by the third quarter of the year and introduce it in both domestic and overseas markets.
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| President Yoon Suk-yeol takes a look at SK Bioscience's COVID-19 vaccine at the company's office in Seongnam, Gyeonggi Province, April 25, when he was president-elect. Courtesy of Presidential Office |
The biotech arm of SK Group and the International Vaccine Institute (IVI) said they will begin global Phase 3 clinical trials of SK's COVID-19 vaccine candidate GBP510 in Thailand, Nepal and Columbia. SK has been collaborating with the IVI for the development of a Korea-made COVID-19 vaccine.
In Thailand, the clinical trials will be conducted on adults who have been vaccinated twice with GBP510 or other COVID-19 vaccines. In Nepal and Colombia, the booster shot effects of GBP510 will be checked for adults who have been vaccinated twice with other companies' COVID-19 vaccines.
In April, SK Bioscience received approval by the Ministry of Food and Drug Safety for Phase 3 clinical trials to confirm the effectiveness of the GBP510 as a booster shot. Booster shots are performed on people who have been vaccinated twice to evaluate immunogenicity and safety.
The company claims GBP510 is a COVID-19 vaccine that improves the immune response through booster shots and is expected to be sufficiently safe.
The company submitted a biologics license application to the Ministry of Food and Drug Safety and is waiting for approval of GBP510. If approved, it will be the first domestically developed COVID-19 vaccine.
"We expect approval to be available within the first half of this year," a company spokesman said.
The company has said it plans to complete the approval of its COVID-19 vaccine candidate GBP510 from the U.K., Europe and the World Health Organization (WHO) by the third quarter of the year and introduce it in both domestic and overseas markets.
