The Korea Herald


[Newsmaker] Approval of South Korea’s 1st homegrown vaccine likely next week

SK Bioscience’s SKYCovione expected to obtain government authorization as early as next week

By Kan Hyeong-woo

Published : June 24, 2022 - 15:43

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SK Bioscience’s COVID-19 vaccine SKYCovione (SK Bioscience) SK Bioscience’s COVID-19 vaccine SKYCovione (SK Bioscience)
South Korea is inching closer to approving its first homegrown vaccine with expectations that the government’s official announcement could come as early as next week.

According to pharmaceutical industry sources Friday, the Ministry of Food and Drug Safety has been considering the review process for SK Bioscience’s COVID-19 vaccine candidate GBP510 since the company submitted a request for the approval of its biologics license application under the name “SKYCovione” in April.

The Drug Ministry said it could not confirm when the approval would potentially take place at the moment, as the review process is currently underway.

“Regarding the COVID-19 vaccine, the government will swiftly announce its decisions to the public as soon as they are official. But it is difficult to give predictions on when SK Bioscience’s vaccine will be approved,” a ministry official said.

An SK Bioscience official told The Korea Herald that the company is hoping to get the government’s approval before the end of June, adding that its working group has been closely cooperating with the drug authorities, but no decision has yet been made.

SK Bioscience CEO Ahn Jae-yong previously laid out the goal of having the company’s vaccine approved by authorities within the first half of this year in an online press conference in March.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 global health crisis, SK Bioscience has reached the final stage of developing Korea’s first COVID-19 vaccine for the benefit of Korea and the world,” Ahn said.

SKYCovione is a recombinant protein-based COVID-19 vaccine candidate incorporated with GSK’s pandemic adjuvant. It was jointly developed by SK Bioscience and the Institute for Protein Design at the University of Washington and backed up by the Bill and Melinda Gates Foundation and Coalition for Epidemic Prevention and Innovation.

Prior to the submission, the drug developer announced that it had secured positive results from phase 3 clinical trials of SKYCovione. SK Bioscience conducted the last clinical trials in 4,037 people over the age of 18 at 16 medical institutions in South Korea, Thailand, Vietnam, New Zealand, Ukraine and the Philippines.

According to the company, the results confirmed that SKYCovione demonstrated immunogenicity superiority in comparison to Vaxzevria, the control vaccine jointly developed by Oxford University and AstraZeneca.

SK Bioscience said the results also demonstrated SKYCovione’s clinically acceptable safety profile, as most of the adverse reactions that took place after injection were mild or moderate.

The Korea Disease Control and Prevention Agency signed a purchase agreement with SK Bioscience to buy 10 million doses of SKYCovione in March.

The drug developer said it plans to apply its vaccine for the World Health Organization’s emergency use listing while looking to obtain authorization from other countries’ regulators to expand its reach to the global market.