SK Bioscience has applied for CMA of SKY Covione

Full-scale global certification and plan to apply for permission to EMA, etc

SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator.

 

The product name in the UK and Europe is SKY Covione.

 

SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA.

 

Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission.

 

SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA.

 

MHRA will begin a full-fledged review for SKY Covione's CMA.

 

Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL).

 

Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said.

 

"In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine.

 

SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network.

 

It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response.

 

It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL.

 

SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad.

 

Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1).

 

SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.