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Period
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Pre-pandemic
When the pandemic broke out
↓ |
Pandemic
(Pandemic outbreak-Before development of vaccines/medicines) When vaccines/treatments are developed
↓ |
Pandemic
(After development of vaccines/medicines) |
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|---|---|---|---|---|
| Category | Preparation | Response | Supplementation | |
| Strategy |
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Preparation phase: Establishing a system for the rapid development of vaccines/medicines before the outbreak of a pandemic
○ (Priority) Selecting five targets (focusing on hemorrhagic fever viruses and respiratory viruses, etc.) selected as priorities domestically and internationally (WHO, CEPI).
- Target selection through risk assessment in epidemiology and expert advice at the infectious disease crisis stage
* (Domestic and international priorities) COVID-19(SARS, MERS, etc.), Influenza, Nipah, Lassa, etc.
○ (Prototype libraries) Securing priority pathogens or prototypes with high imilarity in advance
- Establishing and operating a vaccine library that utilizes the ‘Center for Advanced Vaccine Processing Technology*’ to discover antigens and to stockpile vaccine prototypes to respond to pandemics
* Promoting projects to build and operate an advanced vaccine process base (KRW 47 billion from 2024 to 2027), ‘Basic plan and design (KRW 1 billion in 2023)
- Selecting already approved antiviral agents (U.S. FDA) including drug repurposing, and developing highly efficient broad-spectrum antibody medicines
○ (Securing platform)Localizing mRNA core technologies and new technologies
- Localizing various vaccine platforms (mRNA, recombination, etc.) and new vaccine technologies
- Establishing rapid mass antiviral drug search technologies and medicine discovery platforms
○ (Unresolved infectious diseases)Leading the development of vaccines and treatments for unresolved/public security-threatening infectious diseases such as SFTS and 3rd generation smallpox
- Developing vaccines and treatments for severe fever thrombocytopenia syndrome (SFTS), which has a high risk (mortality and morbidity rate) both domestically and internationally
- Promoting the state-centered research and development of non-commercial vaccines related to public security, such as 3rd-generation smallpox
Response phase: Rapid development of vaccines/medicines in the event of a pandemic(MOHW, MSIT, MOTIE, MFDS)
○ (Rapid development)Promoting rapid development of vaccines/medicines within 100/200 days depending on the level of the prototype secured.
- Establishing a pre-pandemic preparedness system, including a multi-ministerial and institutional collaboration system, securing prototypes,
➊(100 days, Track 1) When a prototype with confirmed safety and capacity of Phase 1/2 clinical trials for the target pathogen is secured
➋(200 days, Track 2) When a prototype with high similarity to the target pathogen is secured (e.g., SARS-CoV-3)
* The period required is the period prior to regulatory review, and the period of clinical trials may vary depending on the recruitment of their participants etc.
< Strategy (Plan) for rapid development of vaccines and medicines to respond to pandemics >
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Types
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Non-clinical trials
Stage 1 :
Initial clinical trials ↓ |
Phase 1/2 clinical trial
Stage 2 :
Phase 3 clinical trial ↓ |
Phase 3clinical trial
Stage 3 :
Clinical completion ↓ |
Review by MFDS
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Development schedule
(Days) |
Suitable platform
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|---|---|---|---|---|---|---|---|---|
| 1 | 30 days | Skip * When a prototype is secured |
70 days | Review by the MFDS | 100 days | (Vaccine) mRNA (Medicine)Antiviral drugs, etc. |
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| 2 | 40 days | 60 days | 100 days | 200일 | ||||
○ (Clinical/Non-clinical) Promoting the rapid development of vaccines/medicines through multi-institutional cooperation to provide full support, including clinical/non-clinical trials,
- Multi-institutional cooperation in related work: (MOHW) Clinical, (MSIT)) Non-clinical, (MOTIE) Production, (MFDS) approval support, etc.
| Institution Name | Project Name |
|---|---|
| KDCA | Project to support the development of public vaccines (2022-2026), project to support the development of new technology-based vaccine platform (2022-2025), Project to support clinical trials for mRNA vaccines against new variants of infectious diseases (2022~2027) Project to develop technologies to overcome viral infectious diseases causing national crisis (2023~2024) |
| MOHW | Project to develop technologies in infectious disease prevention and treatment(2020-2029), Project to rapidly develop technologies in universal vaccines (2022-2026), Project to develop high-value vaccines with future growth (2022-2026), Project to develop vaccine-based technologies (2026) 22-'26), Project to develop antiviral medicines for RNA virus infectious diseases (2023-2029) |
| MSIT | Project to support the development of new drugs (2022-2024) |
| MOTIE | Project to support commercialization of biopharmaceutical raw materials (2022-2025), Project to establish the K-Bio CMO Center (2017-2021) Project to establish the PCMO(2017-20'21) |
- Shortening the clinical period by operating an international clinical research and immunological surveillance system* through cooperation with overseas research institutes, international organizations, etc.
* Korean PREMISE (Pandemic REsponse REpository through Microbial and Immunological Surveillance and Epidemiology): The immune surveillance system of the U.S. NIH/NIAID
○ (Center for clinical research in infectious diseases) Performing rapid national-level clinical research by supporting clinical trial network operation, protocol design, efficacy evaluation, and reference materials.
* Establishment of a new Seoul branch of the National Institute of Infectious Diseases (Center for Clinical Research in Infectious Diseases-1 center, 4 departments, 42 employees) and establishment of a clinical research data center (KRW 50 billion/6 years expected)
○ (Emergency Response Manual)Operating a rapid development system covering the process from clinical trials to approval, based on a mission-oriented full-cycle cooperation protocol among industry, academia, research institutes, and government
- Applying site-oriented emergency response protocols* for each stage of infectious disease crisis warning
* (MSIT) prepares and operates an R&D crisis response manual centered on the Infectious Disease Research Institute Council by linking and expanding it with the basic/mechanical field crisis response manual (virus simulation training, etc.) and high-speed (100-day) MOHW development strategy he .
Supplementation phase: Determining whether to apply a vaccine/medicine based on the evaluation of its immunogenicity and therapeutic clinical efficacy
○ (Immunogenicity evaluation)Establishing a cohort of vaccinated people, conducting a long-term follow-up survey on immunity, and reflecting it in vaccination policies, etc.
○ (Treatment efficacy evaluation)Making a post evaluation, such as evaluation of clinical efficacy based on application of a medicine, and analysis of effectiveness in case of the outbreak of a mutation
○ (Efficacy evaluation)Strengthening the operation and utilization system of the drug efficacy evaluation base laboratory and clinical trial specimen analysis laboratory (GCLP)
○ (Facilities/Resources)Establishing plans to actively use BSL-3/4 facilities and NCCP Resources
