Government "SK Bioscience-developed domestic COVID-19 vaccine, 10 million doses pre-purchased"

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

[Asia Economy Reporter Lee Chun-hee] The domestically developed COVID-19 vaccine 'GBP510' by SK Bioscience is expected to be introduced in South Korea within this year.

On the 23rd, the government held the 12th meeting of the 'Intergovernmental Support Committee for COVID-19 Therapeutics and Vaccine Development' and announced that it will pursue the advance purchase of up to 10 million doses of the vaccine developed by SK Bioscience to support the domestic COVID-19 vaccine.

The government explained that SK Bioscience's COVID-19 vaccine 'GBP510' met the conditions for advance purchase, including the announcement of the second interim results and approval of the third clinical trial plan, which were decided at the 10th meeting held in June. The Korea Disease Control and Prevention Agency (KDCA) has allocated 192 billion KRW in next year's budget for the advance purchase of the domestic vaccine.

SK Bioscience's GBP510 is a COVID-19 vaccine candidate jointly developed by SK Bioscience and the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy, utilizing GlaxoSmithKline (GSK)'s adjuvant technology. In August, the phase 3 clinical trial plan was approved, and a large-scale global phase 3 trial is underway with 3,990 participants including more than 500 in South Korea, as well as in Vietnam, Ukraine, Thailand, New Zealand, and the Philippines. On the 21st, the National Institute of Health under the KDCA began efficacy evaluation (neutralizing antibody analysis) on phase 3 clinical samples, indicating that the phase 3 trial is progressing smoothly.

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

On the 5th of last month, results were also announced showing that in the phase 1 and 2 clinical trials conducted on 328 healthy adults, over 99% of the group administered with the adjuvant developed neutralizing antibodies that neutralize the COVID-19 virus. The level of neutralizing antibody induction two weeks after completion of vaccination was about six times higher in the pseudovirus-based neutralization assay (PBNA) compared to the serum panel of recovered COVID-19 patients in the overall clinical group analysis. In plaque reduction neutralization test (PRNT) analysis on some groups, it was 3.6 times higher, and in enzyme-linked immunosorbent assay (ELISA) results, binding antibodies were about 13.3 times higher compared to the serum panel of recovered patients.

SK Bioscience aims to obtain approval from the Ministry of Food and Drug Safety (MFDS) in the first half of next year. The company plans to rapidly commercialize the vaccine by obtaining the World Health Organization (WHO) prequalification (PQ) certification and emergency use authorization from overseas countries. The government also plans to continue a focused support system for phase 3 clinical trials, including ▲strengthening recruitment of clinical trial participants, ▲supporting overseas clinical trials, and ▲rapid sample analysis, to ensure the domestic vaccine can be commercialized in the first half of next year.

Celltrion's COVID-19 antibody treatment 'Rekkironaju'
[Image source=Yonhap News]

Meanwhile, the government will continue to provide ongoing support for the development of domestic COVID-19 therapeutics. Currently, besides Celltrion's 'Rekkirona' (active ingredient 'Regdanvimab'), which received formal approval on September 17, 17 candidate substances from 16 companies are undergoing clinical trials.

Considering the characteristics of oral therapeutics for mild to moderate patients that must be administered within five days of symptom onset, the government plans to confirm willingness to participate in clinical trials at the stage of hospital bed allocation upon COVID-19 diagnosis and prioritize hospital bed allocation to clinical trial institutions after comprehensively considering hospital bed availability. Additionally, five 'dedicated residential treatment centers for therapeutic clinical trials' have been designated to enable clinical trials at residential treatment centers where mild patients are mainly admitted.

Opportunities for clinical trial participation for patients under home treatment will also be expanded. Participants in clinical trials during home treatment will participate through visits by research nurses or outpatient care, and if they wish to be admitted to a residential treatment center, they will be preferentially assigned to centers where clinical trials are possible.

[Image source=Yonhap News]

Various incentives will also be provided to strengthen research and development (R&D). The government plans to ease the proportion of total R&D costs borne by companies participating in therapeutics and vaccine R&D projects, which currently ranges from 25% to 50%. For vaccines, this applies to phases 1 to 3 clinical trials, and for therapeutics, it applies to phases 2 to 3 clinical trials and new drugs excluding drug repositioning, with plans to review easing private sector burden rates and cash burden rates.

To support such development, the government has allocated a total budget of 545.7 billion KRW for next year. This is a 107.7% increase compared to this year's main budget of 262.7 billion KRW, and a 26.1% increase compared to the total budget of 432.7 billion KRW including supplementary budgets.

A total of 321 billion KRW will be invested in the development of therapeutics and vaccines. 89.3 billion KRW will be allocated for clinical support, and particularly, 10.5 billion KRW will be invested in supporting messenger ribonucleic acid (mRNA) clinical trials, which are attracting attention as next-generation vaccine platforms. 192 billion KRW will be invested for domestic vaccine advance purchase, and 10 billion KRW will be provided for bio-medical technology development.

Additionally, 119.3 billion KRW will be allocated for research and production infrastructure construction, 36.4 billion KRW for upgrading quarantine supplies and equipment, and 69 billion KRW for strengthening basic research.

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