UPDATE : Wednesday, August 21, 2019
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Regulator OKs GC’s P3 trial of BCG vaccine
  • By Lee Han-soo
  • Published 2019.02.25 14:07
  • Updated 2019.02.25 14:07
  • comments 0

GC said Monday that the Ministry of Food and Drug Safety has approved its phase 3 clinical trial of GC3107, a bacillus calmette–guérin (BCG) vaccine.

GC headquarters in Yongin, Gyeonggi Province.

The company plans to evaluate the efficacy and safety of the vaccine by injecting the treatment in 10 healthy infants at the Catholic University of Korea St. Vincent’s Hospital.

BCG vaccine is a mandatory vaccine included in the nation’s vaccine self-sufficient plan. Korea imports all of its BCG vaccines, but there were concerns last year about the safety of imported vaccines because of the detection of arsenic.

To raise the self-sufficient ratio of the vaccine, GC has been localizing BCG vaccine since 2009 with government support and has completed a BCG vaccine production facility at its plant in Hwasun, South Jeolla Province, in April 2011.

The company plans to localize the drug according to the schedule of its clinical trials and product licensing.

The government is supporting vaccine development to localize 28 kinds of vaccines. It has already attained half of its goal as local companies have localized 14 vaccines. The government plans to reach vaccine self-sufficiency rate of 57 percent by 2020 and 75 percent by 2023.

corea022@docdocdoc.co.kr

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