SK bioscience said on Monday that it received WHO Emergency Use Listing (EUL) of its Covid-19 vaccine,SKYCovione.

This makes SKYCovione the 12th Covid-19 vaccine granted an EUL by the World Health Organization (WHO). The WHO EUL is an assessment for listing three categories of medicines including vaccines, therapeutics, and in vitro diagnostics to expedite the availability of these products in a public health emergency.

Earlier in May, SKYCovione won approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

SKYCovione is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for SARS-CoV-2 with GSK’s adjuvant. The vaccine also utilizes the University of Washington’s RoseTTAFold software to create protein structures with enough precision to place individual atoms exactly where desired.

Additionally, the vaccine demonstrated neutralizing antibody responses against SARS-CoV-2 parental strain and had a standard safety and reactogenicity profile in phase 3 trials.

SKYCovione is based on recombinant protein vaccine technology which has been used for the development of vaccines including influenza, and HPV vaccines. The vaccine can be stored between 2-8 °C, enabling greater access to vaccines in low-income countries where ultra-low cold chain storage facilities are not available. 

“Based on the immunogenicity and safety profile, SKYCovione has become the first Korean vaccine to be granted to the WHO EUL and we will continue to develop more vaccines to strengthen Korea’s vaccine sovereignty,” said SK bioscience President & CEO Ahn Jae-yong.

Currently, SK bioscience is also accelerating the development of a universal vaccine targeting Covid-19 and its variants, sarbecovirus, with support from CEPI.