Despite Efforts to Develop COVID-19 Vaccine... Why Domestic Clinical Approvals Remain Zero

20 Companies Launch Development Without Even Applying for Clinical Trial Plans
Also Viewed as Stock Price Pumping

Moderna, a US biotech company developing a COVID-19 vaccine, is conducting clinical trials at its clinical development and manufacturing facility in Norwood, Massachusetts.

[Asia Economy Reporters Choi Dae-yeol and Cho Hyun-ui] Although news continues to emerge about efforts to develop treatments or vaccines for the novel coronavirus disease (COVID-19), it has been revealed that no domestic companies have yet received approval from authorities for clinical trial plans.

According to the Ministry of Food and Drug Safety on the 18th, the only drug approved for clinical trials related to COVID-19 so far is Remdesivir, developed by the US-based pharmaceutical company Gilead Sciences. Originally developed as a treatment for Ebola virus, it was decided to proceed with clinical trials after it was found to have therapeutic effects against COVID-19. The pharmaceutical company and Seoul National University Hospital each applied for Phase 3 and Phase 2 clinical trials respectively, which were approved earlier this month. Patient recruitment is currently underway, and trial results are expected as early as May.

In addition, it is estimated that nearly 20 places in Korea have embarked on developing COVID-19 treatments or vaccines, but so far none have even reached the stage of applying for clinical trial plans before entering clinical trials. The Korea Centers for Disease Control and Prevention and other authorities issued national project research calls for treatment and vaccine development, with many pharmaceutical and bio companies participating and starting their own research, but tangible results have yet to be achieved.

An official from the Ministry of Food and Drug Safety stated, "Some pharmaceutical companies or institutions are currently in consultation before submitting Investigational New Drug (IND) applications, but no IND approvals have been granted yet," adding, "Once IND applications are received, they will be reviewed by experts and approved if deemed appropriate."

The only treatment approved for temporary use specifically for COVID-19 treatment is HzVSF v13 by Immunemed. This treatment use approval is a kind of special case, allowing limited use upon application by specific medical staff within medical institutions, even though clinical trials have not yet been completed. Originally developed targeting influenza, the substance has completed Phase 1 clinical trials and is preparing for Phase 2.

Although pharmaceutical and bio companies have announced plans to develop COVID-19 treatments and vaccines, experts predict that it will take considerable time before these can actually be used on patients. The World Health Organization (WHO) estimated in early last month, when many COVID-19 cases occurred in China, that vaccine development would take about 18 months. While treatments developed for other purposes like Remdesivir could be used sooner if their efficacy and safety are proven, clinical trial results must still be awaited.

Inside and outside the related industry, some view negatively the dissemination of information with low feasibility by certain companies aiming to boost their corporate value. A Ministry of Food and Drug Safety official said, "Some listed companies appear to have impure intentions, such as disclosing inaccurate information," and added, "Clinical trials will not be disclosed before formal approval is obtained."

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