Korea now world's 3rd country with both homegrown Covid-19 vaccine, treatment
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The Ministry of Food and Drug Safety (MFDS) on Wednesday announced its decision to give a greenlight to the application of SKYCovione on condition of a promise of final clinical data submission.
The ministry said its permission came after thoroughly verifying safety and effectiveness of the vaccine, and the evaluation was in accordance with global examination standards.
The Korea’s first Covid-19 vaccine is given in two doses with an interval of four weeks.
With the approval, South Korea became the third country in the world behind the United States and Britain to have both a homegrown Covid-19 vaccine and a therapy. In February 2021, South Korea approved Regkirona, a genetically modified neutralizing antibody treatment developed by Celltrion, for high-risk adult patients with mild and moderate symptoms.
SKYCovione is a recombinant-protein vaccine that has demonstrated superiority versus its comparator vaccine. Thanks to its long-proven vaccine platform technology, a recombinant-protein vaccine is potentially much cheaper to manufacture at scale than mRNA vaccines and may not require ultra-cold storage.
SK bioscience will seek emergency use listing from the World Health Organization and prepare for future distribution of SKYCovione through the COVAX Facility.
SK bioscience shares lost 5.50 percent to 103,000 won ($79.33) on Thursday morning.
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