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| SK Bioscience's SKYCovione COVID-19 vaccine / Courtesy of SK Bioscience |
By Park Jae-hyuk
SK Bioscience's SKYCovione, also known as GBP510, was approved for use, Wednesday, becoming Korea's first locally-developed COVID-19 vaccine to get the green light.
The Ministry of Food and Drug Safety (MFDS) announced that it authorized the use of the recombinant protein-based vaccine.
"Getting advice from three different advisory committees, the ministry thoroughly inspected the vaccine's safety and efficacy," Food and Drug Safety Minister Oh Yu-Kyoung said. "In collaboration with various institutions, we will make efforts to preemptively counteract infectious diseases in the future."
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| Minister of Food and Drug Safety Oh Yu-Kyoung announces the approval SK Bioscience's SKYCovione COVID-19 vaccine at the ministry's briefing room in Cheongju, North Chungcheong Province, Wednesday. Yonhap |
SK Bioscience CEO Ahn Jae-yong said, "The development of Korea's first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics."
SKYCovione was developed jointly with GlaxoSmithKline (GSK) and the Institute for Protein Design (IPD) at the University of Washington, supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).
In the phase 3 clinical trial on 4,037 adults aged over 18, conducted in cooperation with 16 institutions, including Korea University Guro Hospital and the International Vaccine Institute (IVI), the vaccine induced neutralizing antibody responses against the parental strain, according to SK Bioscience.
The company said the neutralizing antibody titers, or the level of antibodies in a blood sample, increased about 33 times two weeks after the second dose. The proportion of participants who seroconverted or saw more than a fourfold increase in neutralizing antibody titers, was 98.06 percent, according to the company. For participants aged over 65, the antibody conversion rate reached 95.3 percent, it said.
SK Bioscience is preparing for heterologous and homologous booster clinical trials of SKYCovione so the vaccine can be used more widely. It also plans to conduct trials on adolescents and children.
In addition, the company will ask the World Health Organization to list SKYCovione for emergency use, so that the vaccine can be distributed to developing countries without requiring ultra-cold chain facilities. According to SK Bioscience, the vaccine can be stored in normal refrigeration conditions ranging from 2 to 8 degrees Celsius.
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