Phase III Trial
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced the company has received the WHO Emergency Use Listing (EUL) of its COVID-19 vaccine, SKYCovione.
SKYCovione is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for SARS-CoV-2. The vaccine was developed with the Institute for Protein Design (IPD) at the University of Washington SCHOOL OF MEDICINE and uses GSK’s pandemic adjuvant. The development of SKYCovione has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 Programme. SKYCovione is also the world’s first medicine developed using computational protein design, an approach that uses Rosetta software to engineer protein structures with enough precision to place individual atoms exactly where desired.
Results from a Phase III clinical trial showed that SKYCovione™ induced neutralizing antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogenicity profile. Subsequently, SKYCovione (known as SKYCovion in the UK) was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older in May 2023.
SKYCovione is based on recombinant protein vaccine technology which has been used for development of vaccines including influenza, and HPV vaccines. The vaccine can be stored between 2-8 °C, making it suitable to use in countries where ultra-low cold chain storage facilities are not available. The ease of distribution helps to achieve greater access to vaccines in low-income countries.
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 develop more vaccines to not just strengthen Korea´s vaccine sovereignty, but also enable equitable access of the vaccine.”