The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione.
SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.
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Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.
It was developed in collaboration with the Institute for Protein Design (IPD) at the University of Washington School of Medicine, with funding support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).
The vaccine is based on recombinant protein vaccine technology and is suitable for storage between 2°C and 8°C.
In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain.
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By GlobalDataThe findings also showed that the Covid-19 vaccine had a standard safety and reactogenicity profile.
SK bioscience CEO Jaeyong Ahn stated: “Based on [its] immunogenicity and safety profile, SKYCovione has become the first Korean vaccine to be granted the WHO EUL.
“We will be committed to developing more vaccines, not just to strengthen Korea´s vaccine sovereignty but also to enable equitable access to the vaccine.”
Last month, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorisation for SKYCovione to prevent Covid-19 resulting from SARS-CoV-2 infection in people aged 18 years and above.
