SK bioscience receives marketing authorisation of COVID-19 vaccine in UK

SK bioscience, based in South Korea, has announced the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation (MA) for SK bioscience’s COVID-19 vaccine SKYCovion as a primary series for strong immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. It becomes the 8th COVID-19 vaccine authorised by the UK’s independent medicines regulator. The authorisation covers England, Scotland, and Wales. 

The MHRA’s decision is based on data from the Phase III trial that showed the vaccine induced neutralising antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogenicity profile after administered as a primary vaccination of two doses.

SKYCovion, the protein-based vaccine developed with GSK’s pandemic adjuvant, can be stored between 2-8 degrees Celsius, making it suitable to use in countries where ultra-low cold chain channels are not available. This helps achieving the vaccine equity and vaccination coverage in low-income countries.

SK bioscience has also applied for an Emergency Use Listing (EUL) from the World Health Organization (WHO) and Marketing Authorisation (MA) from the European Medicines Agency (EMA).

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.