식약처 "SK바이오 코로나19 백신 임상 3상 승인"
A domestically developed COVID-19 vaccine candidate received approval by the nation's drug ministry for a final stage clinical trial.
This is the first for homegrown coronavirus vaccine.
Hong Yoo gets us better acquainted with the process and the product.
A COVID-19 vaccine candidate developed by SK Bioscience has been approved by the Ministry of Food and Drug Safety for a phase three clinical trial.... the first for a domestically developed vaccine.
At this stage, the vaccine candidate labeled "GBP510," will be compared with AstraZeneca's vaccine for efficacy and safety.
GBP510 uses gene recombination technology to induce an immune response by injecting surface antigen protein of the coronavirus... the same technology used by Novavax.
A total of 3-thousand-990 people above the age of 18 will be test subjects for the clinical trial.
3-thousand of them will be given with the vaccine candidate and the rest with AstraZeneca's.
They will all receive 0-point-5 milliliters of a shot... two times, getting the second shot 4 weeks after the first.
The final clinical trial will be carried out not only in South Korea but in Southeast Asia and Eastern Europe.
The Food and Drug Ministry explained that the vaccine candidate has shown sufficient safety and immunogenicity in previous stages, proving that it is capable of entering the final stage.
In Stage 1, all 80 adult subjects inoculated formed neutralizing antibodies.
In terms of safety, no particular side effects were noted aside from tiredness and muscle pain.
President Moon Jae-in, in response to the approval, said the government will provide full support to ensure that domestic clinical trials are carried out quickly and thoroughly.
He has previously emphasized the importance of securing vaccine sovereignty.
The Blue House spokesperson said that the President hopes South Korea is able to bring a domestic vaccine to the market.
In a meeting with his top aides on Monday, Moon said that they will speed up the development of domestic vaccines and concentrate all state capacity in building a global hub so as not to be deterred by overseas firms.
Hong Yoo, Arirang News.
#COVID19 #vaccine #approval
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2021-08-10, 22:00 (KST)
