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“Mass production of Corona 19 antibody treatment this month … for verification of the production process”
Initially advertised as ‘commercial’, but notified of the review as ‘for process verification’
“I think it will be possible to take full approved drugs until next year.”
Quarantine authorities expected to be able to mass produce COVID-19 antibody treatments for ‘production process verification’ within this month.
Antibody treatments for “process validation” can be used for clinical use and can also be sold commercially with approval through additional clinical trials.
Reporter Seungjae Kim reports.
[기자]Antibody therapy that can prevent the penetration of the Corona 19 virus or stop the proliferation process.
Quarantine authorities, which have been conducting clinical trials with the aim of developing next year, have announced plans to mass produce antibody treatments for ‘production process verification’ within this month.
[권준욱 / 중앙방역대책본부 부본부장 : 국내 경증환자 대상 임상 1상은 지난 8월 25일에 승인을 받아서 현재 환자 모집 중에 있습니다. 현재는 식약처에서 임상시험 계획 2·3상을 심사 중이며….]Initially, authorities announced in a briefing that they would mass produce “commercial antibody therapies”, but later revised the announcement as “for verification of the production process.”
The ‘process validation’ treatments are performed in commercial production facilities.
It can be used for clinical use and can be marketed for commercial use with additional clinical trials and authorization.
The full medication schedule is expected to be available next year.
[권준욱 / 중앙방역대책본부 부본부장 : 희망하기는 연구개발 그리고 수급 노력의 성과로 최소한 내년도 추석은 금년도 상황과 다를 것이라고 말씀드리고자 합니다.]Research on plasma treatment using antibodies in the plasma of a cured person is also undergoing clinical trials at national medical institutions.
Remdesivir, a treatment that can be given to seriously ill or seriously ill patients, has so far been given to 49 hospitals and 274 patients.
All 16 have been confirmed dead.
Authorities said that even though they were given remdesivir, they should not be misinterpreted as if they died, and that the effect of remdesivir and the cause of death should be thoroughly analyzed later.
Regarding the COVID-19 vaccine, quarantine authorities aim to ensure and inoculate a safe and effective vaccine until Chuseok next year.
This is YTN Seungjae Kim.
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