SK Bioscience seeks approval for its SKY Covione COVID vaccine in Europe
SK Bioscience has applied for conditional approval for the use of SKY Covione, a COVID-19 vaccine, with the European Medicines Agency (EMA).
SKY Covione, developed jointly by the biotech affiliate of SK Group and the Institute for Protein Design (IPD) at the University of Washington, is a synthetic vaccine considered safer than those originating from bacterial cultures.
The Bill & Melinda Gates Foundation provided funding for the product development.
According to Phase 3 clinical studies, the vaccine is significantly more immunogenic than the control vaccination Vaxzeria from AstraZeneca, according to SK Bioscience.
Extensive research in Phase 1 therapeutic trials showed that SKY Covione also induced a potent immune response against BA.1, of the Omicron variant family, when provided with booster shots.
The SK affiliate anticipates that the product will have a competitive advantage in the international market, which requires a consistent and stable supply of vaccines in the upcoming months.
Once it is added to the World Health Organization (WHO) Emergency Use List, it will be distributed to the global market through the COVID-19 Vaccines Global Access (COVAX) project, a global program created to enable equal access to COVID-19 vaccines.
According to data from the Korea Customs Service, Korea imported $2.35 billion worth of vaccines last year, a seven-fold rise from $340 million the year before.