South Korea on Wednesday approved the use of SKYCovione, the country's first homegrown COVID-19 vaccine developed by SK Bioscience Co., 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 of the ministry's Final Inspection Committee, following an "item approval" recommendation by MFDS' Central Pharmaceutical Affairs Council on Monday, Yonhap news agency reported.
SKYCovione is the country's first homegrown vaccine to have successfully completed all three phases of its clinical trial. SK Bioscience conducted a phase-three clinical trial on some 4,000 adults in six countries -- Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.
It is a recombinant-protein vaccine based on novel two-component nanoparticles that can maximize the immune effect. It 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 in a four-week interval.
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