MFDS: "Domestic Vaccine Development Must Be Achieved... Mobilizing All Resources to Support"

Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety (right), is speaking at the domestic vaccine development support meeting held on the afternoon of the 13th at the Millennium Hilton Seoul in Jung-gu, Seoul.
[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] On the afternoon of the 13th, the Ministry of Food and Drug Safety held a meeting at the Millennium Hilton Hotel in Jung-gu, Seoul, with domestic COVID-19 vaccine developers and related government departments to discuss support measures, the ministry announced on the same day.

The meeting was attended by representatives from companies currently conducting clinical trials for COVID-19 vaccine development, including Cellid, SK Bioscience, UbioLogics, Genexine, and GeneOne Life Science, as well as HK Inno.N and Curetis, which are preparing for development. On the government side, the Ministry of Economy and Finance, Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, and Korea Disease Control and Prevention Agency participated, along with the Korea BioPharmaceutical Association.

The participating companies requested the government to provide guidelines related to comparative clinical trials and also demanded financial support for clinical trials and government advance purchases.

The Ministry of Food and Drug Safety plans to actively support through the introduction of a 'comparative clinical trial' method that compares the efficacy and safety with already approved overseas vaccines, and plans to revise the vaccine development guidelines for the rapid design of phase 3 clinical trials by next month.

Additionally, the ministry will strengthen international cooperation for the rapid establishment of immune correlates of protection (ICP) and prepare guidelines by next month to enable the use of ICP for domestically developed vaccines once established. Immune correlates of protection are surrogate markers that indicate the correlation between immune responses such as antibodies induced by the administered vaccine and protective effects.

The ministry also plans to institutionalize the National Central Institutional Review Board (Central IRB) to enable rapid integrated review during multi-center clinical trials. The related amendment to the Pharmaceutical Affairs Act was approved last month by the Health and Welfare Committee's subcommittee in the National Assembly.

Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety, said, "All three vaccines approved by the ministry are overseas-developed vaccines, so domestic vaccine development is a goal that must be achieved through public-private cooperation," and added, "The government will mobilize all possible administrative power and resources to ensure no shortcomings in the development environment, so we ask the industry to focus all their capabilities to accelerate vaccine development and research."