MFDS to support domestic vaccine for COVID-19

Director Kang-rip Kim "Reduce the number of subjects, establish an inexpensive immunity proxy"

The MFDS has announced that it will establish a new indicator that eases the phase 3 clinical criteria for the existing COVID-19.

 

Through this, the plan is to support the rapid commercialization of domestically developed vaccines.

 

Director Kang-rip Kim made such a statement at a briefing at the special quarantine inspection meeting in response to COVID-19 on the 12th.

 

Director Kim said, "We will promote the rapid establishment of immune surrogate indicators that enable clinical trials at low cost and with a smaller number of subjects compared to the existing phase 3 clinical trials," and "guide for vaccine development using immune surrogate indicators.

 

We will cooperate with international organizations such as WHO as well as presenting the line in detail and securing basic data by analyzing the immunogenicity of the vaccinated person." In addition, he added, "We will also promote technical support for production and quality control, such as establishing production technology and test methods for each platform of vaccine for most domestic vaccine developers without mass production experience." Phase 3 clinical trials of COVID-19 vaccine are administered together with placebo to compare the number of confirmed cases, which requires tens of thousands of subjects, which is expensive and time consuming, and the speed varies depending on the environment of COVID-19 occurrence.

 

Accordingly, the industry is demanding the establishment of an immune proxy to replace this, which is being reviewed positively by the MFDS.

 

The MFDS is also planning to expand the scope of clinical trials for Regkirona, a domestic antibody treatment.

 

"The domestic antibody therapy Regkirona is limited to the use of the elderly, cardiovascular, respiratory, diabetes, and hypertensive patients due to the lack of clinical evidence due to short-term development." "We will support the expansion to patients with reduced immunity and obesity such as heart disease and cancer." He emphasized, "If we approve treatment purposes for emergency patients, we will support timely treatment of corona patients, such as shortening administrative procedures." Lastly, the MFDS promised to support the rapid introduction of self-test kits.

 

Therefore, it is an explanation that we will cooperate with related ministries to shorten the development period, which normally takes 8 months, to less than two months.