SK Bioscience, a global biotech company, has obtained Marketing Authorization (MA) from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, SKYCovion.
The authorization establishes SKYCovion as a primary series vaccine for individuals aged 18 and above to prevent Covid-19 caused by the SARS-CoV-2 virus.
The MHRA's decision was based on compelling data from Phase III clinical trials, demonstrating that the SKYCovion vaccine elicited strong neutralizing antibody responses against the SARS-CoV-2 parental strain. Additionally, the vaccine exhibited a standard safety profile and minimal reactogenicity when administered as a primary vaccination consisting of two doses.
“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,” Jaeyong Ahn, CEO of SK bioscience, said in a press release.
“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,” he said.
The MHRA's decision adds SKYCovion to the list of approved Covid-19 vaccines in the UK, covering England, Scotland, and Wales.
SKYCovion, developed in collaboration with GSK's pandemic adjuvant, is a protein-based vaccine that can be stored at temperatures between 2-8 degrees Celsius. This makes it suitable for use in regions where ultra-low cold chain infrastructure is limited.
SK Bioscience has also submitted applications for Emergency Use Listing (EUL) to the World Health Organization (WHO) and Marketing Authorization (MA) to the European Medicines Agency (EMA) for SKYCovion.
SKYCovion, the world's first-ever vaccine of its kind, has been developed using a groundbreaking software tool called RoseTTAFold. It is an innovative software created by the University of Washington which utilizes deep learning technology to rapidly and accurately predict protein structures, even with limited information
SK Bioscience is also expanding its portfolio to ensure its competitiveness in preparation for the endemic phase of the pandemic, including the development of universal pan-sarbecovirus vaccines.
Additionally, the company said it is also working on polyvalent vaccines and conducting pre-clinical trials for mRNA vaccine platform development.