WHO Approves Emergency Use Listing to SK bioscience's Covid-19 vaccine, SKYCovione

SK bioscience, a global innovative vaccine and biotech company dedicated to promoting human health from prevention to cure, announced that its Covid-19 vaccine, SKYCovione, has received the WHO Emergency Use Listing. SKYCovione is a self-assembled nanoparticle vaccine for SARS-CoV-2 that targets the receptor binding domain of the SARS-CoV-2 Spike protein.

The vaccine was created in collaboration with the Institute for Protein Design (IPD) at the University of Washington SCHOOL OF MEDICINE and employs GSK's pandemic adjuvant. SKYCovione was developed with funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), as well as support from the European Union (EU)'s Horizon 2020 Programme. According to the findings of a phase III clinical trial, SKYCovione induced neutralising antibody responses against the SARS-CoV-2 parental strain and had a typical safety and reactogenicity profile.

Following that, in May 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) approved SKYCovione (known as SKYCovion in the UK) for active immunisation to prevent Covid-19 caused by SARS-CoV-2 in individuals 18 years of age and older. SKYCovione is based on recombinant protein vaccine technology, which has previously been used to develop vaccines such as influenza and HPV vaccines.

The vaccine can be stored at temperatures ranging from 2 to 8 degrees Celsius, making it suitable for use in countries lacking ultra-low cold chain storage facilities. The ease of distribution contributes to greater vaccine access 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.”