KDCA Accelerates Phase 2 Clinical Trial of Homegrown mRNA Vaccine as It Moves to Secure Vaccine Sovereignty

[Financial News] The government is moving ahead with Phase 2 clinical research for a homegrown mRNA vaccine, stepping up efforts to secure "vaccine sovereignty."
The plan goes beyond developing a COVID-19 vaccine. It aims to build an in-house mRNA platform that can respond to future pandemics and later expand into cancer and rare disease treatments.
The National Institute of Health under the Korea Disease Control and Prevention Agency (KDCA) said on the 24th that a research institution participating in the "Pandemic Preparedness mRNA Vaccine Development Support Project (R&D)" had submitted an Investigational New Drug application (IND) for a Phase 2 trial of a COVID-19 mRNA vaccine candidate to the Ministry of Food and Drug Safety.
The application was filed after prior review by the ministry, based on results from earlier Phase 1 clinical and preclinical studies. It is a key step toward launching follow-up trials.
The government's "Pandemic Preparedness mRNA Vaccine Development Support Project" is a national R&D program that develops a domestic COVID-19 vaccine based on messenger RNA (mRNA) technology and supports the entire process from preclinical studies through Phase 3 trials.
Its ultimate goal is to secure a domestic platform that can rapidly develop vaccines when new infectious diseases emerge in the future.
Since last year, the KDCA has been supporting preclinical and clinical research centered on institutions with core mRNA technologies. It has also worked with relevant ministries, including the Ministry of Food and Drug Safety, to provide support on both technology and regulation.
The Phase 2 trial will proceed based on the results of the Phase 1 study that GC Biopharma Corp. conducted and received approval for last year.
The National Institute of Health recently completed the selection process for the institution that will carry out the Phase 2 research project. It plans to begin the study in August after signing an agreement.
If the ministry approves the IND, Phase 2 trials will begin to evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine candidate in healthy adults.
The government expects the study to become a turning point not only for COVID-19 vaccine development, but also for securing domestic mRNA platform technology.
mRNA technology is regarded as a next-generation platform that can be used not only for infectious disease vaccines, but also for a wide range of biopharmaceuticals, including cancer vaccines and treatments for rare diseases.
As the COVID-19 pandemic intensified technological competition, research and development has accelerated in the United States and Europe. In Korea, too, the need for technological self-reliance has been steadily raised.
Nam Jae-hwan, director of the National Institute of Health, said, "The mRNA platform is a core technology that can be used not only for COVID-19 preventive vaccines, but also for developing treatments for various infectious diseases, cancer, and rare diseases." He added, "We will actively support research infrastructure so that the Phase 2 project can be carried out successfully, and work closely with related agencies to provide comprehensive support across technology and regulation."
Lim Seung-kwan, KDCA commissioner, also said, "We hope to secure vaccine sovereignty and strengthen the protection of public health rights through the development of a homegrown COVID-19 mRNA vaccine." He added, "We will continue to strengthen cooperation between research institutions and relevant ministries, and provide all necessary support for successful R&D."
[email protected] Kang Jung-mo Reporter