Vaccine Info

SKYCovione COVID-19 Vaccine

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Staff
Last reviewed
August 19, 2022
Fact checked by
Robert Carlson, MD
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SKYCovione™ COVID-19 Vaccine Description

SK bioscience SKYCovione™ (GBP510) is a recombinant protein-based vaccine made of proteins that form tiny particles studded with fragments of the pandemic SARS-CoV-2 coronavirus. These nanoparticles were designed by scientists at the University of Washington UW School of Medicine and advanced into clinical trials by SK bioscience and GlaxoSmithKline (GSK) with financial support from the Coalition for Epidemic Preparedness Innovations.

SKYCovione was developed at the University of UW of Medicine and includes GSK's pandemic adjuvant, AS03, a substance to help strengthen the immune response to the vaccine.

The Phase III clinical trial results showed that SKYCovion induces neutralizing antibody responses and had an acceptable safety and reactogenicity profile compared to the control vaccine, AstraZeneca’s Vaxzevria™, used in the study. In addition, the extended phase I/II clinical trials showed a high immune response to the Omicron variant BA.1 after a booster of SKYCovion. The clinical trial was conducted with 16 institutions, including the Center for Vaccine of Korea National Institute of Health, the International Vaccine Institute, and Korea University Guro Hospital.

The Korean Ministry has approved SKYCovione of Food and Drug Safety for use on June 29, 2022, in individuals 18 years and older. In addition, the South Korean government has agreed to purchase 10 million doses for domestic use. As of August 18, 2022, the European Medicines Agency (EMA)'s vaccine committee had started a review of SK Chemicals GmbH's conditional marketing authorization application for Skycovion. On July 29, 2022, an authorization application was submitted to the U.K.

SK bioscience intends to make SKYCovion™ available through the COVAX Facility for procurement and equitable allocation worldwide should an Emergency Use Listing be obtained from the World Health Organization.

SK bioscience is an innovative biopharmaceutical company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines.

SKYCovione Indication

SKYCovione is indicated to prevent the disease COVID-19 caused by the SARS-CoV-2 virus. When a person is given the vaccine, their immune system is expected to identify the nanoparticles containing parts of the spike protein as foreign and produce natural defenses - antibodies and T cells - against them. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

“This intramuscular vaccine was designed at the molecular level to present the immune system with a key part of the coronavirus spike protein. We know this part, called the receptor-binding domain, is targeted by the most potent antibodies,” said Neil King, an assistant professor of biochemistry at UW Medicine and co-developer of the vaccine.

SKYCovion Booster

SK bioscience announced that SKYCovione had shown cross-neutralizing activity against Omicron variant BA.1 following booster vaccination administered ~7 months after the primary series. The results of Phase I/II clinical trial, conducted with 81 healthy adults who received a booster dose of SKYCovione 7 months after the second dose of SKYCovione™, showed that the neutralizing antibody titers against the Omicron variant BA.1 were 25 times the titers right after the second dose, and 72 times the titers 7 months after the second dose. 

SKYCovione News

August 18, 2022 - The EMA’s human medicines committee started a review of a conditional marketing authorization application for Skycovion, a vaccine for protecting against COVID-19.

August 1, 2022 - SK bioscience announced that it had submitted an application for a Conditional Marketing Authorization for SKYCovion to the European Medicines Agency.

July 29, 2022 - SK bioscience announced that it applied for a Conditional Marketing Authorization of the SKYCovion to the UK Medicines and Healthcare Products Regulatory Authority.

June 29, 2022 - The Seattle scientists behind the new vaccine sought to create a ‘second-generation’ COVID-19 vaccine that is safe, effective at low doses, simple to manufacture, and stable without deep freezing. These attributes could enable vaccination on a global scale by reaching people in areas where medical, transportation and storage resources are limited.

SKYCovione Clinical Trials

A Phase 3 clinical trial, Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19), compared the immunogenicity and safety of SKYCovione recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to Oxford/AstraZeneca vaccine Covishield/Vaxzevria in adults aged 18 years and older. The results indicated that SKYCovione elicits roughly three times more neutralizing antibodies than the Oxford/AstraZeneca vaccine Covishield/Vaxzevria. In these studies, SKYCovione or Covishield/Vaxzevria was administered twice with an interval of four weeks. In the Phase 3 trial, there were again no serious adverse reactions to the vaccine.

Phase 1/2 trial results announced by SK bioscience last November and posted as a preprint found that SKYCovione was safe and produced virus-neutralizing antibodies in all trial participants receiving the adjuvanted vaccine. 

Clinical Trials

No clinical trials found