SK Bioscience COVID-19 Vaccine Phase 3 Approval... Green Light for 'First Domestic' Vaccine

SK Bioscience Enters Phase 3 Clinical Trials
Aiming for Commercialization in the First Half of Next Year

A researcher at SK Bioscience is conducting research to develop a vaccine. (Photo by SK Bioscience)

SK Bioscience's COVID-19 vaccine under development, ‘GBP510,’ has received approval from the Ministry of Food and Drug Safety (MFDS) for its Phase 3 clinical trial plan, signaling a green light for the development of a ‘domestic vaccine.’ This is the first time a vaccine developed by a domestic company has entered Phase 3 clinical trials. SK Bioscience plans to commence the final clinical trial aiming for commercialization in the first half of next year. ▷Related article on page 2

The MFDS approved the Phase 3 clinical trial for GBP510 on the 10th after a comprehensive review of internal assessments and the results of an advisory meeting held the previous day. The MFDS explained, "Based on the non-clinical and Phase 1 interim analysis results of GBP510, it was judged that entering Phase 3 clinical trials is possible in terms of safety and immunogenicity, and the clinical trial was designed to demonstrate the efficacy of the test vaccine." This Phase 3 trial will evaluate the immunogenicity and safety of GBP510 in adults aged 18 and over. The AstraZeneca (AZ) COVID-19 vaccine, which has already been approved domestically, will be used as a comparator vaccine for the comparative clinical trial. This is the second such comparative clinical trial in the world, following the entry of a COVID-19 vaccine developed by Valneva (France) into a comparative trial against the AZ vaccine. Clinical trials will be conducted simultaneously not only in Korea but also in various countries including Southeast Asia and Eastern Europe.

However, ‘patients with autoimmune diseases such as thrombosis or immune thrombocytopenia’ have been excluded from this clinical trial. This decision was made following the advisory meeting held the previous day, where external clinical experts on COVID-19 vaccines recommended excluding these autoimmune disease patients due to known side effects of the comparator AZ vaccine.

Kim Gang-lip, head of the MFDS, emphasized, "The approval of this clinical trial is significant as it marks the first step toward domestic vaccine self-sufficiency, with the first domestic vaccine entering Phase 3 amid the ongoing COVID-19 pandemic."

On the same day, SK Bioscience’s stock price reached a new high of 265,500 KRW during trading, driven by strong second-quarter earnings and growing expectations for the development of a domestic COVID-19 vaccine.

This content was produced with the assistance of AI translation services.