"Leap to Become a Top 5 Global Vaccine Powerhouse by 2025"…Government to Invest 2.2 Trillion Won Over 5 Years (Comprehensive)

May 5 K-Global Vaccine Hub Vision and Strategy Announcement
"Beyond COVID-19, Enhancing Overall Vaccine Capabilities to Leap as a 'Vaccine Hub'"
First Domestic COVID-19 Vaccine Development in Early Next Year
Full-Scale Effort Including Phase 3 Clinical Trial Cost Support and Advance Purchase Promotion

[Asia Economy Reporter Kim Ji-hee] "We will fully support the development of domestic vaccines."

The government will invest 2.2 trillion KRW by 2026 to leap forward as a global vaccine hub. It aims to commercialize the first domestically produced COVID-19 vaccine by the first half of next year by supporting the costs of Phase 3 clinical trials and promoting advance purchases. Additionally, it presented a blueprint to become one of the top five global vaccine powers by 2025.

On the 5th, the Ministry of Health and Welfare held a ‘K-Global Vaccine Hub Vision and Strategy’ briefing session chaired by President Moon Jae-in at the Blue House and government offices in Seoul and Sejong, announcing these results. At this briefing, the basic direction for becoming a global vaccine hub was set, and the ‘Global Vaccine Hub Promotion Committee,’ chaired by the Prime Minister, was launched.

Lee Kang-ho, head of the Global Vaccine Hub Promotion Team, said at the briefing after the session, "We are working to enhance overall vaccine capabilities and promote a leap to a global vaccine hub, and above all, the COVID-19 vaccine is crucial," adding, "Currently, South Korea ranks 9th globally, but if we actively pursue the vaccine hub policy as we are now, we believe we can sufficiently achieve 5th place by 2025."

[Image source=Yonhap News]

Support for Advance Purchase of Domestically Developed COVID-19 Vaccines

According to the K-Global Vaccine Hub Vision and Strategy, the immediate task of supporting domestic COVID-19 vaccine development will be actively pursued. Various supports for Phase 3 clinical trials will be promoted to facilitate rapid development. Currently, seven companies, including SK Bioscience, which is expected to enter Phase 3 trials in the second half of this year, are conducting COVID-19 vaccine clinical trials.

Particularly, intensive financial support will be provided for Phase 3 trials. To this end, 166.7 billion KRW was secured through supplementary budgets this year. Furthermore, for COVID-19 vaccines that have produced interim results from Phase 2 trials and have approved Phase 3 trial plans, advance purchases will be promoted considering immunogenicity, safety, and success probability comprehensively. An additional 72 billion KRW has been allocated from the supplementary budget for this purpose.

Minister of Health and Welfare Kwon Deok-cheol explained at the briefing, "The vaccine currently leading development is the protein recombinant vaccine, and we will strive to commercialize it through Phase 3 trials by the first half of next year," adding, "Efforts are also underway to develop mRNA vaccines, and the Ministry of Health and Welfare, Korea Disease Control and Prevention Agency, Ministry of Science and ICT, and Ministry of Trade, Industry and Energy are sharing roles to support the gap technology." In particular, a dedicated mRNA development task force has been separately formed to support preclinical and clinical trials, and the Korean Intellectual Property Office is also involved to develop independent technology avoiding overseas companies’ patents.

To support rapid entry into Phase 3 trials, the clinical approval period will be shortened by half, and a nationally designated central clinical trial review committee will be operated to promote integrated multi-center reviews. Support will also be provided to secure comparator vaccines for ‘comparative clinical trials,’ which compare domestically and internationally approved vaccines with domestic vaccine candidates.

Up to 3 Billion KRW for Expanding Vaccine Production Infrastructure

To establish a vaccine hub foundation, efforts will focus on four key tasks: expanding production capacity, rapid development of next-generation vaccines, global advancement of domestic vaccines, and fostering the vaccine industry ecosystem. Up to 3 billion KRW per company will be supported for building various vaccine and raw material production facilities and equipment. Companies without their own facilities will be able to utilize global-standard vaccine GMP-grade public manufacturing facilities.

Self-sufficiency in raw material technology will also be pursued. Following a demand survey for raw materials needed for vaccine production in June and a priority review for self-reliance in July, a plan for raw material self-sufficiency will be prepared. In particular, commercialization support will include comparative testing, performance evaluation, and startup growth technology development, and a package-type support system will be established covering R&D, materials and components, and smart factories.

Considering the possibility of repeated infectious disease pandemics in the future, support for various strategic vaccines will be strengthened. This includes developing multivalent and universal vaccines usable against various variant viruses, rapid production vaccine platforms, high value-added vaccines, and vaccines that are less favored by the private sector. Vaccine base technologies such as immune adjuvants and fundamental and original research will also be reinforced to support these efforts.

Minister Kwon said, "From September this year, vaccine investment areas will be designated as advanced investment zones to attract global companies’ investments," adding, "Samsung Biologics is planning pilot production of Moderna’s mRNA vaccine finished products from the end of August this year, and the government will actively support smooth production."

Global Expansion of Domestic Vaccines... Financial Support Also Provided

Global market entry of domestic vaccines will also be promoted. The trade insurance limit for vaccine export will be expanded up to twice the current amount. Financial support will be pursued for domestic production facility investments aimed at vaccine exports. To strengthen international cooperation at the national level and respond to new variant infectious diseases, pathogen resource information and specimens will be secured, and overseas research bases will be established.

Using the Korean version of NIBRT (a bio workforce training program introduced through a consulting contract with the National Institute for Bioprocessing Research and Training in Ireland) and vaccine demonstration support centers (in Hwasun and Andong), specialized personnel for vaccine process development will be trained. A support system for training basic research personnel, medical science personnel, and regulatory science experts to enhance the competitiveness of the bio industry will also be established. In particular, 2.8 billion KRW has been secured in this supplementary budget for training vaccine process personnel through the NIBRT program. Full-scale personnel training will begin in the second half of this year.

Prime Minister Kim Boo-kyum emphasized, "We must concentrate national capabilities to become a genuine global vaccine hub through this opportunity," adding, "We will unite efforts to realize the shared vision and strategy centered on the newly launched public-private Global Vaccine Hub Promotion Committee."

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