Company submitted an application for CMA of SKYCovione™ to MHRA and EMA, followed by EUL to WHO.

If approved, Company will accelerate an emergency use authorization with global regulatory agencies.

[2022, Sept 8] Seoul, South Korea- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, today announced that the Company has submitted an Emergency Use Listing (EUL) application to the World Health Organization for ‘SKYCovione™’, South Korea’s first homegrown COVID-19 vaccine.

The WHO EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a public health emergency. As of August 2022, there are 11 COVID-19 vaccines are listed on the EUL.

In July, the company also has applied for a Conditional Marketing Authorization (CMA) of SKYCovione™ (SKYCovion™ in Europe) to the Medicine and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). If approved by global regulatory authorities, SKYCovione™ will be made available to COVAX for allocation worldwide, at its discretion.

SKYCovione™, a recombinant protein vaccine with GSK’s pandemic adjuvant, can be stored between 2-8 degrees Celsius, making it suitable to use in lower-middle-income countries where deep freeze facilities are not available.

Jaeyong Ahn, CEO of SK bioscience said, "SKYCovione™, selected as the first vaccine candidate for the project Wave 2 operated by the Coalition for Epidemic Preparedness Innovations (CEPI) from the beginning of development, is now ready for the global market,” adding, “We will secure the vaccine sovereignty and respond to the COVID-19 endemic stage by accelerating the emergency use authorization from global regulatory authorities.”

SKYCovione™ is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union’s Horizon 2020 Programme.

The results of the global Phase III clinical trial showed that SKYCovione™ induced neutralizing antibody responses against the SARS-CoV-2 parental strain and had a standard safety and reactogenicity profile. In addition, SKYCovione™ also showed cross-neutralizing activity against Omicron variant BA.1 when administered as a booster. The clinical trials were conducted in cooperation with 16 institutions, including Korea University Guro Hospital and International Vaccine Institute (IVI), and supported by Center for Vaccine Research at Korea National Institute of Health.