The Korea Herald


SK Bioscience applies for SKYCovione's WHO emergency use listing

By Kan Hyeong-woo

Published : Sept. 8, 2022 - 11:47

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SK Bioscience's Andong L House in North Gyeongsang Province (SK Bioscience) SK Bioscience's Andong L House in North Gyeongsang Province (SK Bioscience)
SK Bioscience has completed the application for an emergency use listing of SKYCovione -- South Korea’s first homemade COVID-19 vaccine -- with the World Health Organization, the local vaccine developer said Thursday.

The WHO’s emergency use listing is the global health body’s procedure for reviewing vaccines, therapeutics and in vitro diagnosis with the goal of expediting the availability of such products to people in case of a public health emergency. As the WHO’s assessment checks data on quality, safety and efficacy, the listing usually guides countries and international procurement agencies under the United Nations in determining whether to acquire certain products.

There were a total of 11 COVID-19 vaccines on the WHO’s emergency use listing as of Thursday. The WHO’s emergency use listing is required for drug makers to sign up for international bidding by global agencies such as UNICEF, the Pan America Health Organization and the Global Alliance for Vaccines and Immunizations.

Once SKYCovione’s WHO emergency use listing is completed before the end of this year, SK Bioscience said the company plans to begin distributing its COVID-19 vaccine to the global market through COVAX, a worldwide initiative to guarantee equitable access to COVID-19 vaccines for everyone on Earth.

The vaccine maker also applied for conditional approvals of SKYCovione with the UK’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency in July.

SK Bioscience said the homemade COVID-19 vaccine, which was developed as a synthetic antigen vaccine, can be stored and distributed at room temperatures allowing for easier transportation for the products to be supplied to different parts of the world.

According to international statistics tracker Our World In Data, eight in 10 people in developing countries have not received COVID-19 vaccination.

“SKYCovione, which was selected as the first development project for (next generation COVID-19 vaccines) by the (Coalition for Epidemic Preparedness Initiative) in the early stages of the vaccine research, is finally getting ready to enter the global market,” said Ahn Jae-yong, CEO of SK Bioscience.

“We will promptly obtain approval from global organizations and countries to take the lead in responding to the COVID-19 endemic and securing global vaccine sovereignty.”