HOME

TheInfoList



OR:

Skycovione is a
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...
candidate developed by SK Bioscience and the Institute for Protein Design of the
University of Washington The University of Washington (UW, simply Washington, or informally U-Dub) is a public research university in Seattle, Washington. Founded in 1861, Washington is one of the oldest universities on the West Coast; it was established in Seattle a ...
, It is South Korea's first homegrown Covid-19 vaccine and utilizes GSK's
AS03 AS03 (for "Adjuvant System 03") is the trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline (GSK). It is used, for example, in GSK's A/H1N1 pandemic flu vaccine Pandemrix. It is also in Arepanrix a ...
adjuvant technology. 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. In April 2022, results of the phase III trial confirmed the vaccine to be safe and effective. It elicited approximately three times more antibodies than the
Oxford–AstraZeneca COVID-19 vaccine The Oxford–AstraZeneca COVID19 vaccine, sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by Oxford University and British-Swedish comp ...
. Should the vaccine be approved by health regulators, it will be distributed via the
COVAX COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
program. The South Korean Government has ordered 10 million doses for domestic use. 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. 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. On June 29, 2022, Skycovione was approved for use in South Korea. The vaccine needs an additional safety review because "the number of participants in Skycovione's trial was only one-tenth of other vaccine trials". In November 2022, the production of SKYCovione was indefinitely suspended because of short demand of the vaccine. South Korean government purchased 10 million doses of SKYCovione of which 600,000 doses released into hospitals. However only 3,787 shots of them have been administered as of November. Unused doses of the vaccine are likely to be discarded.


References


External links

Clinical trials South Korean COVID-19 vaccines Science and technology in South Korea Protein subunit vaccines {{Vaccine-stub