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Government to Advance Early Purchase of Domestic COVID-19 Vaccine... "Full Support for Phase 3 Clinical Trials in Q3"

Government to Advance Early Purchase of Domestic COVID-19 Vaccine... "Full Support for Phase 3 Clinical Trials in Q3"

[Asia Economy Reporter Seo So-jeong] The government has decided to promote advance purchases of vaccines with a high likelihood of success to accelerate the development of domestically produced COVID-19 vaccines.


On the 25th, the government held the 10th meeting of the Pan-Government Support Committee for COVID-19 Therapeutics and Vaccine Development and announced plans to promote advance purchases by comprehensively considering immunogenicity, safety, and likelihood of success when a vaccine enters Phase 3 clinical trials or when interim results from Phase 2 clinical trials are obtained.


Currently, five domestic vaccine developers?SK Bioscience, YuBioLogics, Genexine, GeneOne Life Science, and Cellid?are conducting Phase 1 and 2 clinical trials, aiming to progressively enter Phase 3 clinical trials starting in the second half of the year. Domestic companies have long demanded that the government actively engage in advance purchases to establish vaccine sovereignty and promote the development of K-vaccines.


The government plans to fully support Phase 3 clinical trials starting in the second half of this year. First, the budget for vaccine clinical support will be increased from 49 billion KRW last year to 68.7 billion KRW this year, with additional budget procurement planned if necessary. The operation of the National Designated Central Institutional Review Board (Central IRB) will also be expedited. Through integrated multi-center reviews, the inconvenience of having to obtain approval from each medical institution’s Institutional Review Board (Institutional IRB) will be resolved, facilitating rapid entry into clinical trials.


Preparations such as specimen analysis infrastructure for advancing Phase 3 clinical trials are being pushed to be completed within the first half of this year. To recruit participants for large-scale clinical trials, the National Clinical Trial Support Foundation is conducting pre-recruitment of vaccine clinical participants, and once Phase 3 trials are in full swing, participants will be intensively connected.


Furthermore, recognizing that domestic messenger RNA (mRNA) vaccine technology lags about three years behind overseas, the government will collaborate across ministries to support 39 technology demands in seven fields to close the gap. The 'New and Variant Infectious Disease Response Platform Core Technology Development Project' will also be promoted. This project supports the development of next-generation core technologies covering the entire infectious disease response cycle?from predicting the spread of infectious diseases to rapid diagnosis, treatment, and prevention?by funding 12 tasks over four years from this year through 2024.


Kang Do-tae, Vice Minister of Health and Welfare, said, "We will strive to visualize results early through pan-governmental full support for vaccine Phase 3 clinical trials in the second half of this year," adding, "through concentrated pan-governmental support to secure mRNA vaccine technology, we will advance Korea’s bioindustry and prepare for the post-COVID-19 era."


© The Asia Business Daily(www.asiae.co.kr). All rights reserved.

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