Skycovione

Skycovione is a COVID-19 vaccine candidate developed by SK Bioscience and the Institute for Protein Design of the University of Washington,[2][3][4][5][6][7][8] It is South Korea's first homegrown Covid-19 vaccine[9] and utilizes GSK's AS03 adjuvant technology.

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The phase III clinical trial involves 4,037 participants. Should the trial confirm GBP510's efficacy and safety, the vaccine is expected to be approved in the first half of 2022.[10][11][12][13]

In April 2022, results of the phase III trial confirmed the vaccine to be safe and effective.[14] It elicited approximately three times more antibodies than the Oxford–AstraZeneca COVID-19 vaccine. Should the vaccine be approved by health regulators, it will be distributed via the COVAX program. The South Korean Government has ordered 10 million doses for domestic use.[15]

The Korean Ministry of Food and Drug Safety released the results of their review on SK Bioscience's Skycovione on June 27, 2022 and said the data was sufficient for approval.[9] According to the Korean Ministry of Food and Drug Safety, vaccine-related adverse events occurred in 13.3% of the vaccine group. In the control group, the adverse event rate was about 14.6%, which was not different from the vaccine group. Serious adverse events occurred in 0.5% in the vaccine group and 0.5% in the control group. There was one adverse event of glomerulonephritis which could not be excluded from vaccine association.[9]

On June 29, 2022, Skycovione was approved for use in South Korea.[16] The vaccine needs an additional safety review because "the number of participants in Skycovione's trial was only one-tenth of other vaccine trials".[17]