Government "Actively Supporting Clinical Trials of Domestic COVID-19 Treatments and Vaccines"

[Asia Economy Reporter Cho Hyun-ui] The government has decided to actively support domestic and international clinical trials by companies, aiming to develop a domestically produced novel coronavirus disease (COVID-19) treatment drug within this year and a vaccine by next year.

On the 30th, the government held a meeting of the Pan-Governmental Support Committee for COVID-19 Treatment and Vaccine Development to discuss such support measures.

The government stated, "The goal is to develop at least one treatment drug within this year and one vaccine by next year," adding, "We will focus support on promising companies to ensure clinical trials succeed promptly."

It was reported that companies cited difficulties in recruiting participants for clinical trials as their biggest challenge. Additionally, local medical centers and residential treatment centers where patients are located lack experience and infrastructure for clinical trials, highlighting an urgent need for improvement.

The government will first urgently establish a clinical trial infrastructure within hospitals. A standard guideline will be prepared to enable Institutional Review Boards (IRB) in hospitals to conduct rapid reviews, and the introduction of a 'Central Clinical Trial Review Committee (amendment to the Pharmaceutical Affairs Act)' will be pursued to allow integrated reviews by a nationally designated review committee when multiple hospitals conduct clinical trials.

Standard guidelines for research fund execution will be prepared tailored to the circumstances of clinical trial participating institutions such as local medical centers, and incentives such as personnel cost support for medical staff participating in clinical trials and reflection in local medical center evaluations will be provided.

To activate clinical trials at residential treatment centers where mild patients are admitted, a new clinical trial model will be established and actively reflected in the installation of new centers in the future.

Information provision for citizens wishing to participate in clinical trials will also be strengthened. A dedicated COVID-19 clinical trial website will be launched to provide information about clinical trials to patients admitted to local medical centers or residential treatment centers.

For promising companies nearing the end of clinical trials, concentrated support will be provided through the Ministry of Health and Welfare's 'Clinical Trial Support Task Force (TF)' and the Ministry of Food and Drug Safety’s 'Dedicated Pre-Approval Review Team.' A 'Clinical Research Consultation Support Group (tentative name)' will be operated to offer services such as assistance in preparing clinical data and analyzing results.

Support for overseas clinical trials will also be provided. A comprehensive overseas clinical trial support portal and a comprehensive consultation center will be established to provide related information, counseling, and consulting to interested companies, and face-to-face, in-depth consultations will be offered to companies nearing clinical entry to establish customized overseas clinical strategies.

Through public-private cooperation involving local diplomatic missions of the Ministry of Foreign Affairs, the Ministry of Food and Drug Safety’s Korea International Cooperation Agency, and the Ministry of Science and ICT’s Pasteur Institute, support will be provided for companies’ overseas local clinical trials, and cooperation systems with local regulatory agencies will be strengthened to ensure early approval of clinical trials.

The government will also promote the domestic introduction of vaccines developed overseas. It has already completed the participation process in the global vaccine supply organization 'COVAX Facility' to secure vaccines for 20% of the entire population (about 10 million people). On the 9th, it signed a purchase agreement with the Global Alliance for Vaccines and Immunization (GAVI) and made an advance payment of about 85 billion KRW.

The government plans to promptly conclude negotiations with global companies to secure vaccines for the remaining 40% of the population (about 20 million people). The vaccines to be pre-purchased will be decided after comprehensive consideration of safety and efficacy review results, price, platform, supply timing, and expert opinions.

Park Neung-hoo, Minister of Health and Welfare, said, "It is true that there are difficulties in clinical trials for treatment drugs and vaccines due to a shortage of domestic patients," adding, "Active public interest and participation in clinical trials are necessary."

Choi Ki-young, Minister of Science and ICT, said, "Many drugs are entering clinical trials," and emphasized, "The government, industry, academia, research institutes, and hospitals must unite their capabilities to ensure that companies’ clinical trials proceed smoothly and lead to successful development of treatments and vaccines."

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