Formal Authorization
SK bioscience announced on May 30 that its in-house developed COVID-19 vaccine “Sky Covione” (European name: Sky Covion) has received formal authorization from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) for primary vaccination (first and second doses) in adults aged 18 and over in the U.K., Scotland, and Wales.
Sky Covione is a synthetic antigen COVID-19 vaccine developed by SK bioscience based on a global network. It was jointly developed by the Institute for Protein Design at the University of Washington's School of Pharmacy and SK bioscience, and is enhanced with GlaxoSmithKline’s adjuvant for immune response enhancement and neutralizing antibody induction.
The U.K., known to have stringent regulations for medical product approvals, along with the U.S.’s FDA and Europe’s EMA, makes it quite exceptional for any domestic pharmaceutical industry to gain MHRA approval by conducting the entire process from candidate identification to clinical trials. Sky Covione has been undergoing a rolling review by the MHRA for fast approval since March of last year and obtained formal authorization just one year and two months after its phase 3 clinical trial results.
Starting with this U.K. approval, SK bioscience aims to obtain additional approvals such as inclusion in the WHO Emergency Use Listing (EUL) and marketing authorization from the European Medicines Agency (EMA) to lead the containment efforts in the COVID-19 endemic era and further contribute to the smooth supply of vaccines in developing countries.