SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine
SKYCovion was created in collaboration with GSK's pandemic adjuvant and is suitable for storage between 2° and 8° Celsius.
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion.
SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above.
The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
It was granted based on data from the Phase III study, which demonstrated that the vaccine induced neutralising antibodies against the SARS-CoV-2 original strain.
The vaccine was also found to have a standard safety and reactogenicity profile when administered as a primary two-dose vaccination.
SK bioscience CEO Jaeyong Ahn stated: “We are delighted with the MHRA’s authorisation of Korea’s first Covid-19 vaccine SKYCovion.
“This is the result of our commitment to protecting and promoting global public health. 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.”
SKYCovion, a protein-based vaccine created in collaboration with GSK’s pandemic adjuvant, is suitable for storage between 2° and 8° Celsius.
This makes SKYCovion a suitable option for countries lacking ultra-low cold chain channels.
The company has also submitted applications to the World Health Organisation (WHO) for an emergency use listing and to the European Medicines Agency (EMA) for marketing authorisation.
The Institute for Protein Design (IPD) of the University of Washington School of Medicine is also involved in the development of SKYCovion.
SKYCovion is claimed to be the world’s first-ever vaccine developed by leveraging the RoseTTAFold software tool that uses deep learning.
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