Government to Rapidly Support Phase 3 Clinical Trials of Domestic Vaccine Developers... "Promoting Advance Purchase of Korean Vaccines"

Early Operation of the National Designated Central Institutional Review Board (Central IRB)

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The government will expedite the operation of the nationally designated Central Institutional Review Board (Central IRB) to facilitate the rapid progress of Phase 3 clinical trials by domestic COVID-19 vaccine developers. Additionally, it will secure additional research and development (R&D) budget to support Phase 3 clinical trials and actively promote the advance purchase of domestically produced vaccines once development results become somewhat visible.

On the 7th, the Ministry of Health and Welfare reported on the current status and future plans of domestic vaccine development at the '3rd Special COVID-19 Response Quarantine Inspection Meeting' presided over by President Moon Jae-in.

Currently, five companies?SK Bioscience, YuBioLogics, Genexine, GeneOne Life Science, and Cellid?are conducting clinical trials for vaccine development in South Korea, all of which have completed vaccinations for Phase 1. Among them, some companies have completed recruitment for Phase 2 participants and aim to enter Phase 3 clinical trials step-by-step as early as July this year.

The government will expedite the operation of the nationally designated Central Institutional Review Board to enable domestic vaccine developers to proceed swiftly with Phase 3 clinical trials.

Previously, when pharmaceutical companies conducted clinical trials across multiple medical institutions, each institution’s Institutional Review Board (Institutional IRB) had to approve separately, causing delays in starting clinical trials.

Accordingly, the government plans to introduce the nationally designated Central Institutional Review Board (Central IRB) to minimize unnecessary administrative burdens and facilitate faster clinical trials in line with domestic vaccine Phase 3 plans. After a pilot operation in June this year, full-scale operation will begin in July.

Additional R&D Budget Secured for Phase 3 Support... Priority Vaccination for Clinical Trial Participants

To disperse risks associated with Phase 3 trials and reduce corporate cost burdens, additional R&D budget for Phase 3 support is being secured (internal procedures underway), and the government will actively promote advance purchase of domestically produced vaccines once development results become somewhat visible.

Considering that most domestic developers plan to conduct Phase 3 trials using a comparative clinical trial method, the government will also ensure thorough preparation for securing standard materials, establishing standard operating procedures (SOP), and obtaining control vaccines to facilitate smooth comparative trials.

The comparative clinical trial method verifies the efficacy of the developed vaccine by confirming that its immunogenicity (such as antibody levels) is similar to that of an already approved vaccine.

Furthermore, clinical trial participants will be given priority vaccination either after the trial ends (placebo group) or in case of development discontinuation or failure (including the treatment group).

Minister of Health and Welfare Kwon Deok-cheol stated, "The government will provide 'full support' until domestic vaccine development is completed and will continue efforts at the whole-of-government level to ensure rapid and visible results."