"Incentives and Advance Purchase for Clinical Participants"... Government Focuses Support on Domestic COVID-19 Vaccine Development

Discounts and Reductions for Existing Vaccination Recipients Also Provided to Clinical Trial Participants
National-Led Consortium Formed to Support Rapid Specimen Analysis

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The government is making every effort to support the development of a domestically produced COVID-19 vaccine, aiming for commercialization in the first half of next year. Recently, SK Bioscience received approval for a Phase 3 clinical trial plan using a comparative clinical method, and the government is focusing on supporting patient recruitment and vaccination, approval and review, and commercialization. Specifically, various incentives such as exemption from public institution admission fees will be provided to clinical trial participants, and advance purchases will be promoted to be used for facility investments and other purposes during the vaccine development process.

On the 19th, Kwon Deok-cheol, Minister of Health and Welfare, held a video conference with hospital directors of clinical trial institutions at Korea University Anam Hospital to discuss support measures for the rapid progress of Phase 3 clinical trials. The meeting was attended by representatives from 14 clinical trial medical institutions, Kim Hoon, CTO of SK Bioscience, Kwon Jun-wook, Director of the National Institute of Health, and Bae Byung-jun, Chairman of the National Clinical Trial Support Foundation, among others.

The government plans to operate a focused support system for Phase 3 clinical trials of COVID-19 vaccines. According to the clinical progress stages, a two-step focused support system has been established, covering patient recruitment and vaccination, specimen analysis, approval and review, and rapid commercialization support.

First, about 3,000 pre-registered clinical trial volunteers secured through the National Clinical Trial Foundation will be preferentially linked to companies entering Phase 3 clinical trials. In particular, various incentives will be provided to clinical trial participants who contribute to the development of the national bio-industry despite being eligible for COVID-19 vaccination. A clinical trial participant certificate system will be established to issue certificates to those who have participated or are participating in COVID-19 vaccine clinical trials, offering discounts or exemptions on various public institution admission fees.

Central government ministries and local governments will apply existing discounts and exemptions for COVID-19 vaccine recipients to clinical trial participants as well, and additional support measures will be prepared.

Additionally, four hours of volunteer time will be recognized for each clinical participation, and companies that have employees participating in large-scale clinical trials or have established systems for paid leave or business trips for clinical trial participants will receive extra points during the ‘Community Contribution Recognition Company’ evaluation.

Thorough management is also being ensured for the safe conduct of clinical trials. When participating in clinical trials, medical staff continuously monitor participants’ health status and promptly provide medical treatment in case of side effects. Appropriate compensation will be provided through liability insurance. Recruitment and vaccination of clinical trial participants are scheduled to be completed by the second half of this year.

Once recruitment and vaccination of clinical trial participants are completed, rapid specimen analysis will be conducted to quickly verify the efficacy of the developed vaccine. Although specimen analysis requires biosafety level 3 (BL3) facilities and others, which private sectors lack capacity for, a consortium centered on the National Institute of Health will be formed to support rapid specimen analysis under national leadership.

Support for rapid commercialization such as approval and authorization will also be strengthened upon development completion. The Ministry of Food and Drug Safety has shortened the approval period from 180 days to 40 days through a dedicated organization conducting preliminary reviews.

Furthermore, advance purchases will be promoted to be used for facility and equipment investments and pre-orders of raw materials during the vaccine development process. Considerations will include immunogenicity, safety, and success probability upon obtaining interim results of Phase 2 and entering Phase 3. The government will also provide customized support if companies face difficulties in commercialization, such as raw material supply.

Minister Kwon said, “Rapid development of a domestic vaccine requires public participation and interest in clinical trials, so we ask for your attention and support. We will lead the development of our health industry and successfully promote the K-Global vaccine hub not only by supporting the seven companies currently conducting clinical trials but also by fully supporting companies in the research and development stage of COVID-19 vaccines.”

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