June 30, 2022 12:00
Korea's first homegrown COVID-19 vaccine has been given the green light for use here, the Ministry of Food and Drug Safety said Wednesday.
SKYCovione or GBP510 was developed by SK Bioscience and the University of Washington's Institute for Protein Design.
Korea now has both a COVID treatment with Celltrion's Regkirona, approved in February 2021, and a vaccine, Minister of Food and Drug Safety Oh Yu-kyoung said. "We now have a health security system in place to respond preemptively to an infectious disease in the future."
Like the Novavax vaccine, SKYCovione is a recombinant-protein vaccine based on the same technology used to make flu or Type B hepatitis vaccines. It is less expensive than mRNA vaccines and can be kept in normal cold storage of 2-8 degrees Celsius.
SK Bioscience said the bulk of the vaccine will be sent to African countries at the recommendation of the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill Gates-led international organization that finances vaccines for poor countries which financed the Korean project.
It is given twice at an interval of four weeks. After a third dose, SKYCovione is effective in preventing not only the original coronavirus strain but also Omicron variants, according to SK Bioscience. Clinical testing of booster shots is underway.
A ministry spokesperson said it "tested the safety, effectiveness and quality of SKYCovione according to international standards at all stages from development to clinical testing, production management and final approval."
SK Bioscience still needs approval for emergency use from the World Health Organization before the vaccine can be shipped overseas.
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