SK Bioscience seeks WHO nod for prompt COVID vaccine sale

SK Bioscience Co., the biopharmaceutical unit of South Korea’s No. 2 conglomerate SK Group, sought approval from the World Health Organization (WHO) for the immediate sale of the company’s COVID-19 vaccine to raise its sales and global presence.

SK Bioscience said on Thursday it has applied to the WHO for an emergency use listing (EUL) for SKYCovione, South Korea’s first homegrown COVID-19 vaccine.

The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency such as COVID-19, according to the WHO.

The United Nation’s specialized agency for international public health has registered 11 COVID-19 vaccines on EUL as of August this year.

“SKYCovione has been expected to play a key role in promoting global public health as it was selected as the first one at the early stage of the development for the next-generation COVID-19 vaccine project by the Coalition for Epidemic Preparedness Innovations (CEPI), an international private group,” said SK Bioscience Chief Executive Officer Ahn Jaeyong.

The company aims to take the lead in dealing with COVID-19 by securing necessary approval from health authorities worldwide, Ahn added.

SK Bioscience plans to speed up the supply of SKYCovione worldwide through COVAX Facility, the WHO’s global vaccine distribution platform, and others after securing a EUL status.

In July, the company submitted an application for a Conditional Marketing Authorization (CMA) of SKYCovione to the UK Medicines and Healthcare products Regulatory Agency and the European Medicines Agency.

SKYCovione, which uses synthetic antigens, is easy to store and distribute. The vaccine can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.

Write to Ye-na Kim at yena@hankyung.com
Jongwoo Cheon edited this article.