Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release, April 9, 2020] Industry, Academia, Research, and Hospitals Work Together to Spur Development of COVID-19 Treatments and Vaccines
  • Registration Date 2020-06-17
  • Hit 1189
[Press Release, April 9, 2020 / unofficial translation]



Industry, Academia, Research, and Hospitals Work Together to Spur Development of COVID-19 Treatments and Vaccines
- Mobilize full support to accelerate achievements such as discoveries of repurposed drugs and antibody treatments
- Begin efficacy testing of treatments and vaccines in non-human primates to start in early May
- Provide research infrastructure and resources necessary for the development of treatments and vaccines
- Support the quick start of clinical trials through the speedy review of investigational new drug application (IND) and simplified clinical process


□ The Minister of Science and ICT, the Minister of Health and Welfare, and the Minister of Food and Drug Safety met with experts in the treatment and vaccine field from the industry, academia, research, and hospitals at the Institute Pasteur Korea (Pangyo, Seongnam-si, Gyeonggi-do) on Apr. 9 (Thu) and discussed plans for the rapid development of COVID-19 treatments and vaccines.


□ A government spokesperson emphasized, “the task of developing treatments and vaccines to completely overcome COVID-19 is too huge to accomplish within a short period of time, but we cannot give up,” and requested that “the industry, academia, research, and medical institutions join hands and stay committed until the pandemic ends.”

○ He also emphasized, “by using COVID-19 as an opportunity, we will strengthen the system for private-public sector cooperation and improve regulations to encourage businesses to take on the challenge of developing treatments and vaccines more actively.”


□ Experts who attended the meeting mentioned that the government’s quick R&D support is greatly helping the development of the treatments and vaccines for COVID-19, and also said that in addition to continuous government support in this regard, the implementation of a contingency system that can respond to national infectious disease crises is also needed.


□ In response, the government decided to provide comprehensive support by collaborating with relevant departments to swiftly secure COVID-19 treatments and vaccines.

○ (Emergency research support) The government will be providing support for the development of various treatments that can be applied to COVID-19 patients, including repurposed drugs*, antibody drugs, and plasma drugs, through supplementary budgets, emergency research funding, and reserve funds
- In particular, infected animal models necessary for COVID-19 treatments and vaccines have been developed, and the efficacy of one treatment and two vaccines will be verified in non-human primates infected with COVID-19 in early May.
* Drug repurposing: Confirming whether the drugs of which safety have been proven through market placing or clinical testing are also effective for COVID-19, aside from the original target disease.

○ (Opening up research infrastructure to the private sector) To gather the competencies of the industry, academia, research, and hospitals for the development of COVID-19 treatments and vaccines, the Korean government decided to open up core resources such as research facilities, pathogen resources, clinical data, etc. to the private sector for use.

○ (System improvements for quick clinical trials, etc.) The government decided to drastically reduce the evaluation period for COVID-19 treatments and vaccines through prior consultation and quick examination, recognize test results from a single institution for clinical trials to avoid repetitive testing at multiple institutions, include patients at community treatment centers among clinical test participants, and actively support the streamlining of clinical procedures.

○ (Strengthening international cooperation for COVID-19 treatments and vaccines) The Korean government also plans to build a cooperative system for active sharing of COVID-19-related information with major countries, and expand local research centers, starting with those in Asian regions with a high possibility of infectious disease spreading to Korea.


□ Based on these types of support measures, the government plans to increase investment in infectious disease R&Ds and connect separate infectious disease research organizations to create an effective infectious disease research system.



Attachment : Government-wide Plans to Support Securement of COVID-19 Treatments and Vaccines

◇ Underpin swift securement of COVID-19 treatments and vaccines through ①Emergency research support, ②Stimulation of private sector participation, ③System improvement, and ④Promotion of international cooperation


[1] COVID-19 Treatment and Vaccine Emergency Research Support

○ (Intensive deployment of emergency funding) Provide emergency research fund* for drug re-purposing, antibody drugs, and plasma drugs so that treatments can be secured quickly (MSIT, MOHW)
* provided through emergency response research project/supplementary budget (MSIT) and emergency use/reserve funds/supplementary budget (MOHW, KCDC) to support treatment development programs based on AI and those utilizing blood from recovered patients

○ (Early start of animal testing) Develop animal models (monkeys, mice) infected with the COVID-19 virus and use them for the efficacy evaluation of treatments and vaccines (MSIT, MOHW, MFDS)
※ Non-human primate testing for promising drugs (1 case) and vaccines (2 cases) scheduled to begin in early May

○ (Support for quick application in healthcare settings) Deployment of emergency research funding* for clinical research applying drugs with efficacy at treating COVID-19 proven by laboratories to the actual treatment of patients (MSIT, MOHW)
* Clinical trials on drugs with MFDS’s IND approval to be carried out starting from May, (MOHW) as part of the emergency response research project (MSIT, MOIS)


[2] Creating Environment for Active Participation of Private Sector in Treatment and Vaccine Development

○ (Sharing public research infrastructure) Opening biosafety research facilities (BSL3) that are necessary for virus research but difficult for the private sector to establish to the private sector (MSIT, KCDC)
※ approve the usage of biosafety research facilities by private enterprises after assessing demands from businesses through KoreaBio, and provide additional support through the research facilities of the public vaccine development center (KCDC) will finish building in Oct. 2020

○ (Quick provision of research resources) Accumulation of clinical data and pathogen resources utilized in treatment and vaccine development → Build and operate system for sharing at proper time (MOHW)
※ Share data with institutions including clinical research registration system, national pathogen resource bank, and pathogen resource specialized bank and open up COVID-19 clinical treatment data to academa in Korea and abroad.


[3] System Improvement for Swift Securement of Treatments and Vaccines

○ (Prioritized and accelerated review) Time required for clinical trials related to COVID-19 treatments and vaccines drastically reduced through prior consultation and quick review (MFDS)
※ (Example) Clinical trial examination which normally takes 30 days can be approved in only one day for cases related to COVID-19

○ (Joint examination with Institutional Review Boards) The clinical results from a single institution’s Institutional Review Board (IRB) are accepted to avoid repetitive trials, in cases where IND plans were to be carried out in the same manner at multiple institutions. (MFDS)

○ (Expansion of eligibility for clinical trials) Include patients with mild cases of COVID-19 receiving treatment at community treatment centers in clinical trials → Enable effective clinical trial through gathering a sufficient population (MFDS)
※ Cooperation requested for investigator-initiated study targeting community treatment centers (4/2020)

○ (Streamlining clinical trial procedures) Quick approval for clinical trial participation granted to designated COVID-19 hospital, not implementing institutions, the explanation over the phone and the voice recording of the patient’s consent shall be recognized as evidence (MFDS)


[4] Strengthening International Cooperation for COVID-19 Treatment and Vaccine Development

○ (Securing local research bases) Early procurement of infectious disease research resources (human specimens, pathogens, etc.) and establishment of local research centers for preemptive research (MSIT)
※ Prioritize the establishment of research centers in Asian regions highly associated with imported cases in Korea (late 2020), and then expand to other regions such as Europe and Africa

○ (Strengthening communication with the international community) (MSIT, MOHW) Constructing a close information cooperation system related to COVID-19 through regular meetings with major foreign countries and international organizations
※ Currently holding meetings with ministers and secretaries in science and technology field from 16 major countries related to COVID-19 (from early March, every week), participation in ministerial dialog in the science/technology field hosted by UNESCO (May 30)
※ From WHO International Cohorts Meeting (March), clinical information is exchanged, and international joint research discussion on vaccine standardization and clinical epidemiology


[5] Strengthening Infectious Disease Research Support from Mid- and Long-term Perspectives

○ (Expanding R&D investment) Strengthen basic infectious disease research competencies, and drastically expand infectious disease R&D budget so that products can be rapidly developed during emergency
- Secure technological innovation platforms* that can provide emergency response to infectious diseases (MSIT, MOHW)
※ Next-gen vaccine (DNA, RNA vaccine) development platform, etc.
- Safety and effectiveness evaluation technology development for commercializing treatments and vaccines (MFDS)
- Commercialization follow-up research support and sharing vaccine development infrastructure through public vaccine support center (scheduled to open on Oct. 2020) and vaccine commercialization project group (scheduled to be launched on Jul. 2020)

○ (Creating an efficient research system) Strengthening cooperative research by connecting separate infectious disease research organizations and sharing research resources and facilities (MSIT, MOHW, etc.)
Attached File
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