Reviewed by the Central Pharmaceutical Affairs Deliberation Committee on the 26th
[Asia Economy Reporter Jo In-kyung] The birth of a domestically produced COVID-19 vaccine is imminent. Health authorities are expected to grant marketing authorization for SK Bioscience's 'Skycovione (candidate substance GBP510)' as early as this week. Once final approval is obtained, SK Bioscience will become the first and only company to possess a domestically produced COVID-19 vaccine in Korea.
According to the Ministry of Food and Drug Safety on the 27th, experts in biologics and vaccine review at the Central Pharmaceutical Affairs Deliberation Committee meeting held the previous afternoon concluded that SK Bioscience's 'Skycovione Multi-dose' can be authorized for marketing.
Although the advisory procedure of the 'Final Inspection Committee' for the approval of COVID-19 vaccines and therapeutics remains, it is interpreted that the overall review regarding the vaccine's efficacy, safety verification, and post-approval safety assurance measures has been virtually completed.
This vaccine is a recombinant gene-based COVID-19 preventive vaccine jointly developed by SK Bioscience and the University of Washington in the United States. It is administered twice at a 4-week interval. Unlike messenger RNA (mRNA) COVID-19 vaccines that require storage at ultra-low temperatures, this vaccine can be stored and distributed refrigerated at 2 to 8 degrees Celsius.
When compared with AstraZeneca's COVID-19 vaccine (Vaxzevria) as a control vaccine, it demonstrated superiority in both immunogenicity and safety.
SK Bioscience plans to commence commercialization in the second half of the year immediately upon receiving approval from the Ministry of Food and Drug Safety. The government had previously promised to purchase 10 million doses in March.
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