President Moon's Call for Completion of Therapeutics and Vaccine Development Accelerates Progress but...

[Special Feature] How Life Changes After COVID-19

Rapid Processing of R&D Stage Approvals and Reviews
Total of 858 Global Drug Intervention Clinical Trials
Only 3 Out of 13 Domestic Trials Recruiting Participants
Numerous Experiments Make Meeting Specific Deadlines Difficult

President Moon Jae-in is listening to Senior Researcher Lee Hong-geun explain the compound treatment process at the Korea Pasteur Institute research facility in Seongnam, Gyeonggi Province, last April.

[Asia Economy Reporter Choi Dae-yeol] "It is faster than anything we have ever experienced before."

A representative from a domestic pharmaceutical company developing a treatment for COVID-19 under a government national project made this remark regarding the recent actions of the pharmaceutical approval authorities. Lee Eui-kyung, the current Minister of Food and Drug Safety, has repeatedly emphasized the importance of approval tasks to enhance the competitiveness of the pharmaceutical and bio industries since taking office.

However, due to the conservative nature of new drug development work, it was not easy to change existing practices overnight. As the COVID-19 situation has continued for several months and President Moon Jae-in emphasized the importance of developing treatments and vaccines, urging to "see it through," the atmosphere has shifted.

An industry insider said, "Infectious diseases are unpredictable in terms of when the outbreak will end, making it difficult to decide to conduct research and development (R&D). Even if development succeeds, production and sales remain uncertain, so there is reluctance. This time, with the government swiftly handling document reviews and approvals at the R&D stage and even pledging stockpiling, the burden has been significantly reduced."

The Ministry of Food and Drug Safety has assigned dedicated personnel to each project to fully support COVID-19 vaccine and treatment development, handling approval and review tasks. The review teams are composed of experienced members, and approval tasks are prioritized. Vaccines based on platforms with proven safety have been granted exemptions from toxicity tests, among other measures to accelerate the process. Guidelines have also been issued to reduce trial and error by companies during treatment and vaccine development.

However, many global pharmaceutical companies armed with massive funds and development infrastructure have entered the field, and domestically, as the COVID-19 situation stabilizes and patient numbers decrease, it has become difficult to develop treatments and vaccines. In preparation for when vaccine development gains full momentum, the government has decided to support clinical trials with 100 billion KRW, but major countries such as the United States and the United Kingdom are already set to begin clinical trials as early as next month.

According to the National Clinical Trial Support Foundation, as of the 8th, there are a total of 858 COVID-19 related drug intervention clinical trials worldwide (825 treatment trials and 33 vaccine trials). Among these, only 13 are domestic trials. Of these, only 3 have recruited participants. Relatively advanced clinical trials primarily aim to alleviate symptoms in severe patients, but the number of severe patients domestically has remained around 10 to 20 this month.

An official from a national research institute said, "Vaccine and treatment development is a scientific process that progresses step by step through numerous experiments with a high likelihood of failure, which differs in nature from the existing government departments' tasks that set specific deadlines for completion. Since the R&D ecosystem still has many shortcomings, it is necessary to view the situation realistically rather than harbor overly optimistic hopes."

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