"Development of Korea's First Domestic Vaccine in the First Half of the Year" ... Support for Production of Generic Oral Therapeutics Also Provided

SK Bioscience to Promote Vaccine Inoculation in Second Half of Year
Investment in Development of 'Corona + Flu' Combination Vaccine

Health and Welfare Minister Kwon Deok-cheol (left in the photo) is delivering a greeting at the '13th Government-wide Support Committee for COVID-19 Therapeutics and Vaccine Development' held on the afternoon of the 1st at Lotte Hotel in Jung-gu, Seoul. Photo by Kwon Young-seok

[Asia Economy Reporter Jo In-kyung] The government will strengthen support to enable full-scale vaccination from the second half of the year once the development of the 'first domestically produced COVID-19 vaccine' is completed in the first half of this year. It has also decided to support the entire process of domestic companies producing and exporting generic drugs of oral treatments such as Merck & Company (MSD) and Pfizer.

On the 1st, the government held the 13th meeting of the 'Interministerial Committee for COVID-19 Therapeutics and Vaccine Development Support' to discuss this year's support strategies for COVID-19 vaccine and therapeutic development and the implementation plans by ministries.

First, the government will continue to support related companies this year with the goal of securing autonomy in COVID-19 vaccine and therapeutic development. Currently, 18 domestic companies are conducting clinical trials for 19 COVID-19 therapeutic items, and 9 companies are conducting clinical trials for vaccines.

Among them, the vaccine under development by SK Bioscience is at the stage of completing vaccinations for Phase 3 clinical trial subjects and confirming efficacy through specimen analysis, aiming for development completion in the first half of this year. The government plans to commercialize it in the second half through a pre-purchase contract of 10 million doses of the SK Bioscience vaccine signed on the 21st of last month, and will support early clinical trials for booster shots and for children and adolescents.

Furthermore, the government will invest budget in research and development of various types of vaccines, including multivalent vaccines that can be commonly used against COVID-19, influenza, and other viruses.

To promote global expansion of vaccines and therapeutics developed and produced domestically, support for the production of generics of MSD's oral therapeutic 'Lagevrio' and Pfizer's 'Paxlovid' will also be strengthened.

Currently, three domestic companies?Hanmi Pharmaceutical, Celltrion, and Dongbang FTL?have obtained sublicenses for producing finished products or raw materials of these therapeutics through the Medicines Patent Pool (MPP). Accordingly, an 'Clinical Trial Support Task Force (TF)' composed of eight related ministries including the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Korea Disease Control and Prevention Agency, and three organizations including the National New Drug Development Foundation has been formed to support the entire process of generic drug development, approval, production, and export by these companies at the government-wide level.

In the mid to long term, a 'Korean-style rapid development system for infectious disease response vaccines and therapeutics' and a foundation for original technology development will be established to enable swift response in case of new infectious diseases. A standard plan for infectious disease clinical trials will be prepared, and preclinical trials in the infectious disease field will be overseen through the National Preclinical Support Center. Additionally, R&D support outcomes will be shared through the 'Virus Research Cooperation Council (universities, companies, research institutes)' and the 'Infectious Disease Research Institution Council (government agencies, public research institutes, foundations, etc.).' During the development process, to prevent regulatory or patent issues, a joint regulatory improvement team will be established to exempt preliminary feasibility studies for infectious disease R&D or introduce a rapid review system.

At the meeting, Kwon Deok-cheol, Minister of Health and Welfare, said, "We will continue to support domestic companies in developing vaccines and therapeutics to secure autonomy in COVID-19 vaccine and therapeutic development," adding, "We will strengthen the capabilities of the domestic bio-industry through international cooperation and establish a rapid infectious disease response vaccine and therapeutic development system to prepare for future infectious diseases."