"Research Review Taking 2 Months Now 1 Week" Government Rolls Up Sleeves for Vaccine and Treatment Development (Comprehensive)

Government Provides Comprehensive Support for Domestic Therapeutics and Vaccines
Starting with Studies Eligible for Review Exemption via Shared IRB

Minister of Health and Welfare Park Neung-hoo and Minister of Science and ICT Choi Ki-young are speaking at the 1st meeting of the Pan-Government Support Group for COVID-19 Therapeutics and Vaccine Development held at the Government Seoul Office Building on the 24th. Photo by Yonhap News

[Asia Economy Reporter Cho Hyun-ui] The government will drastically reduce the research review time from the current 1-2 months to 1 week through a shared Institutional Review Board (IRB) to expedite the development of COVID-19 treatments and vaccines.

The Pan-Government Support Group for COVID-19 Treatment and Vaccine Development held its first meeting on the morning of the 24th at the Government Seoul Office and announced this plan. Park Neung-hoo, Minister of Health and Welfare and co-head of the group, stated in his opening remarks, "Although the number of new domestic confirmed cases has decreased to around 10, as many experts predict, the possibility of a resurgence remains high," adding, "The development of treatments and vaccines is essential for the ultimate overcoming of COVID-19."

He continued, "As seen in recent export cases of COVID-19 diagnostic kits, if companies, universities, research institutes, hospitals, and the government unite their efforts in the fields of treatments and vaccines, there is sufficient potential," and added, "We will operate a permanent collaboration system centered on the support group for regulatory improvements and R&D."

The Pan-Government Support Group, co-led by Minister Park and Choi Ki-young, Minister of Science and ICT, was established recognizing that treatments and vaccines are critical hurdles for the complete eradication of COVID-19. It aims to facilitate ongoing collaboration among industry, academia, research, and hospitals, as well as to devise regulatory improvements and support measures.

At the meeting, the support group decided to facilitate rapid review of COVID-19 research through a shared IRB. Research involving clinical information related to COVID-19 or the use of blood from patients or recovered individuals must undergo IRB review before commencement. However, when using an institution’s own IRB, the review process could be lengthy depending on the institution, or there were inconveniences such as differing judgments on whether review exemption applied.

Accordingly, starting from the 29th, the support group will accept and promptly process COVID-19 related research requiring urgent public health measures, including national and local government direct or commissioned research, where IRB review exemption is applicable. Additionally, a special review committee dedicated to COVID-19 research review will be established under the group next month to ensure rapid review procedures for COVID-19 research not eligible for exemption.

Through this, the IRB process, which previously took 1-2 months depending on the institution, will be drastically shortened to within one week. A guideline for review exemption will also be prepared to support rapid exemption reviews at other IRBs.

The support group will also establish priority criteria for clinical trial support. Although demand for clinical trials of treatments and vaccines is surging, there are limitations in available time and eligible patient numbers for support, necessitating a strategic approach to focus support based on priority criteria. The group plans to develop detailed judgment criteria for clinical trial support priorities based on fundamental principles such as patient safety, research ethics, public interest, and international standards.

A pan-government blueprint (roadmap) covering the overall strategy for domestic treatment, vaccine, and quarantine equipment development will also be formulated. The roadmap will include domestic treatment and vaccine development goals and schedules, rapid regulatory support, treatment and vaccine production and national stockpiling, goals and support plans for localization of quarantine equipment, and expansion and rapid support of R&D investments. Drafts will be prepared by sector focusing on industry, academia, research, and hospitals, followed by expert reviews, with major decisions to be announced sequentially by early June.

Currently, about 30 types of COVID-19 treatments and vaccines are under development domestically. There are around 20 treatment projects, including 7 drug repurposing studies expanding indications of existing drugs and 13 new drug developments, and about 10 vaccine projects.

Minister Choi Ki-young of the Ministry of Science and ICT said, "We will prioritize discovering treatment candidate substances through drug repurposing strategies and also focus efforts on vaccine development," adding, "From basic research to understand the characteristics of the COVID-19 virus to overall R&D, we will dedicate ourselves to finding strategies and methods to respond to COVID-19."

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