SK Bioscience's Domestic COVID-19 Vaccine 'GBP510', Domestic Introduction Confirmed (Comprehensive)

In August last year, subject administration for the Phase 3 clinical trial of SK Bioscience's COVID-19 vaccine candidate 'GBP510' was underway at Dong-A University Hospital in Busan. (Photo by SK Bioscience)

[Asia Economy Reporter Lee Chun-hee] The domestic introduction of 'GBP510,' the first Korean-made COVID-19 vaccine developed by SK Bioscience, has been confirmed.

SK Bioscience and the Korea Disease Control and Prevention Agency (KDCA) announced on the 21st that they have signed a domestic advance purchase supply contract for GBP510. The total contract volume is 10 million doses, with a contract amount of approximately 200 billion KRW.

Last December, the government announced plans to advance purchase 10 million doses of the domestic vaccine as support for domestic vaccine development, conditional on the announcement of interim results of Phase 2 clinical trials and approval of the Phase 3 clinical trial plan (IND). Currently, GBP510 has completed the announcement of Phase 2 clinical trial results and is conducting a global Phase 3 clinical trial involving over 4,000 participants worldwide.

However, domestic approval for GBP510 has not yet been granted. SK Bioscience is conducting Phase 3 clinical trials aiming for approval within the first half of the year and plans to begin supply from the second half. Recently, sequential review documents for expedited approval were also submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

GBP510 is a COVID-19 vaccine candidate jointly developed by SK Bioscience and the Antigen Design Institute (IPD) at the University of Washington School of Pharmacy, utilizing GlaxoSmithKline (GSK)'s adjuvant technology. It is a recombinant protein subunit vaccine, the same type as the Novavax COVID-19 vaccine currently under contract development and manufacturing (CDMO) by SK Bioscience. Recombinant protein subunit vaccines have been used in existing vaccines such as influenza and hepatitis B, proving their safety and efficacy, and have the advantage of being stored and distributed refrigerated (2?8°C).

SK Bioscience 'L House Vaccine Center' in Andong-si, Gyeongbuk (Photo by SK Bioscience)

Meanwhile, GBP510, the first domestic COVID-19 vaccine, is expected to serve as a cornerstone for the development of the second and third domestic vaccines. The government has discussed with SK Bioscience the plan to supply GBP510 as a comparator vaccine for follow-up vaccine development by other domestic companies.

Currently, Phase 3 clinical trials conducted by domestic developers using a comparative clinical trial method require the use of an already approved vaccine as a comparator to compare clinical data and demonstrate non-inferiority. GBP510 is also conducting Phase 3 clinical trials using the AstraZeneca (AZ) vaccine as a comparator. However, it is practically difficult to use vaccines developed overseas as comparators, causing many domestic companies to face difficulties in conducting clinical trials. Accordingly, SK Bioscience plans to contribute to the development of the domestic vaccine industry by providing GBP510 as a comparator vaccine in consultation with health authorities.

Considering that the first-dose vaccination rate in Korea has already reached 87.5%, clinical trials for heterologous and booster vaccinations are also underway. SK Bioscience is confirming the safety and efficacy of booster doses through its own clinical trial, administering an additional GBP510 dose six months after participation in Phase 1 and 2 clinical trials of GBP510.

Another booster clinical trial is underway, administering GBP510 as a heterologous booster to adults who have completed their primary vaccination series with other COVID-19 vaccines. This trial is being conducted as an investigator-initiated clinical study led by the National Institute of Health under the KDCA at nine domestic institutions including Korea University Guro Hospital. Following IND approval by the Korea Ministry of Food and Drug Safety in December last year, dosing is currently underway for approximately 550 adults aged 19 to 49.

Jung Eun-kyung, Commissioner of the KDCA, stated, "The utilization of heterologous booster vaccinations after the first and second primary doses with other vaccines will be greater in the future. We are currently conducting safety and efficacy evaluations to establish evidence, and upon approval, we plan to prepare and provide guidelines for heterologous and booster vaccinations based on this evidence."

Ahn Jae-yong, CEO of SK Bioscience, said, "GBP510 is the fruit of SK's technological capabilities, the government's will to leap forward as a bio powerhouse, and the cooperation of global organizations supporting vaccine development for public health rights. Starting with GBP510, we will develop products to prepare for various viral infectious diseases and establish ourselves as a leading company in the global vaccine market."

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