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A sample of a COVID-19 vaccine developed by SK Bioscience is seen in this file photo. Yonhap |
The government approved the use of SKYCovione, Wednesday, the country's first locally developed COVID-19 vaccine by SK Bioscience, taking a major step toward achieving vaccine sovereignty in the fight against the pandemic.
The Ministry of Food and Drug Safety (MFDS) said it approved the use of SKYCovione, also known as GBP510, through consultations with its Final Inspection Committee, following an "item approval" recommendation by the ministry's Central Pharmaceutical Affairs Council, Monday.
SKYCovione is the country's first locally developed vaccine to have successfully completed all three phases of clinical trials. SK Bioscience conducted a Phase 3 clinical trial on 4,000 adults in six countries ― Thailand, Vietnam, New Zealand, Ukraine, the Philippines and Korea.
It is a recombinant-protein vaccine based on novel two-component nanoparticles that can maximize the immunity effect; and was jointly developed with the Institute for Protein Design at the University of Washington.
The vaccine has been designed for recipients to receive two doses with a four-week interval. (Yonhap)