Domestic COVID-19 Vaccine Available as Early as July (Comprehensive)

SK Bioscience, Successful Phase 3 Clinical Trial... Proven Superior to AZ Vaccine

SK Bioscience GBP510.

[Asia Economy Reporter Lee Gwan-joo] Results have shown that the COVID-19 vaccine developed by SK Bioscience demonstrated superior performance compared to the AstraZeneca (AZ) vaccine in Phase 3 clinical trials. If the approval process proceeds smoothly, the first domestically produced COVID-19 vaccine could be administered as early as July.

On the 25th, SK Bioscience announced that its self-developed synthetic antigen COVID-19 vaccine candidate ‘GBP510’ showed a superior immune response compared to the control vaccine in the Phase 3 clinical analysis. GBP510 is a COVID-19 vaccine candidate jointly developed by SK Bioscience and the Antigen Design Research Institute (IPD) at the University of Washington School of Pharmacy, supported by the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations (CEPI). It incorporates GlaxoSmithKline (GSK)’s adjuvant AS03.

SK Bioscience conducted Phase 3 clinical trials involving 4,037 adults aged 18 and over at 16 domestic clinical institutions including Korea University Guro Hospital, as well as in five overseas countries: Thailand, Vietnam, New Zealand, Ukraine, and the Philippines. The results demonstrated the superiority of GBP510 (administered twice at 4-week intervals) over the control vaccine AZ in terms of immunogenicity. GBP510 significantly increased neutralizing antibodies that prevent COVID-19 infection compared to the control vaccine. The seroconversion rate, indicating the proportion of subjects whose neutralizing antibody levels increased fourfold or more after GBP510 vaccination, was also significantly higher than that of the control vaccine.

SK Bioscience plans to secure safety data within this month and apply for product approval from the Ministry of Food and Drug Safety (MFDS). Once the application is submitted, the review process takes 40 days, so if there are no issues, MFDS approval is expected around June. Considering that the Korea Disease Control and Prevention Agency will then prepare vaccination plans and conduct quality inspections, and that the final national release approval takes about 20 days, actual vaccinations are expected to begin in July. SK Bioscience initially aimed for approval within the first half of the year.

SK Bioscience President Ahn Jae-yong said, "The current achievement was possible thanks to the united support of the government, health authorities, international organizations, research institutions, and global companies, as well as the wholehearted encouragement of the Korean people." He added, "Through the successful development of GBP510, we will create a new turning point in global epidemic prevention and fulfill our mission to establish South Korea as a sovereign vaccine-producing nation."