SKYCovione™ COVID-19 Vaccine
SK bioscience SKYCovione™ (SKYCovion™, 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 School of Medicine (UW of Medicine) and advanced into clinical trials by SK bioscience and GlaxoSmithKline (GSK) with financial support from the Coalition for Epidemic Preparedness Innovations. In addition, SKYCovione includes GSK's pandemic adjuvant, AS03, a substance to help strengthen the immune response to the vaccine.
The vaccine consists of GBP510 with the AS03 adjuvant. GBP510 is a self-assembling two-component protein nanoparticle that displays 60 copies of the receptor binding domain (RBD) of SARS-CoV-2 Spike. The nanoparticle component allows for the high-level multimeric display of the RBD antigen that enhances humoral immune responses even at lower doses. This platform also allows for simple and efficient adjustment of the vaccine to match variant strains of SARS-CoV-2 or other emergent pathogens by swapping out the target antigen, which the nanoparticle displays. In addition, the inclusion of AS03 may allow for the use of lower doses of protein antigen.
The Phase 3 clinical trial results showed that SKYCovion induces neutralizing antibody responses and had an acceptable safety and reactogenicity profile compared to the control vaccine, Vaxzevria™, used in the study. In addition, the extended phase I/II clinical trials showed a high immune response to the Omicron variant 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 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. On May 30, 2023, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorization for SK bioscience's COVID-19 vaccine SKYCovion™ as a primary series for strong immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. On June 19, 2023, SkyCovione received an Emergency Use Listing (EUL) from the World Health Organization (WHO). SKYCovione is the 12th COVID-19 vaccine granted an EUL by the WHO.
SKYCovion is the world's first-ever vaccine developed using the RoseTTAFold, a software tool that uses deep learning to quickly and accurately predict protein structures based on limited information. The RoseTTAFold was designed as a three-track neural network developed by the University of Washington.
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 the 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 seven months after the second dose.
SKYCovione News
June 19, 2023 - Jaeyong Ahn, CEO of SK bioscience said, "Based on the immunogenicity and safety profile, SKYCovione has become the first Korean vaccine to be granted to the WHO EUL. We will be committed to developing more vaccines to strengthen Korea's vaccine sovereignty and enable equitable access to the vaccine."
May 30, 2023 - Jaeyong Ahn, CEO of SK bioscience said in a press release, "We are delighted with the MHRA's authorization of Korea's first COVID-19 vaccine SKYCovion. This is the result of our commitment to protecting and promoting global public health. We are confident it will be the milestone to solidify our position in the global market amid the transition of the pandemic to the endemic phase."
August 18, 2022 - The EMA's human medicines committee started reviewing 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.
