SK Bioscience has submitted the application for conditional approval of the COVID-19 vaccine SKY Covione with the European Medicines Agency in efforts to expand its presence in the global market, the South Korean vaccine developer said Monday.

Beginning with the European region, SK Bioscience said it will look to showcase the South Korean COVID-19 vaccine on the global stage as the size of the coronavirus vaccine market grows rapidly.

South Korea’s Ministry of Food and Drug Ministry gave the green light to SKYCovione at the end of June as the country became the third nation in the world with a homegrown COVID-19 treatment and a domestically-developed vaccine, behind the UK and US.

According to global health care market tracker Airfinity, the global COVID-19 vaccine market was estimated at $65.6 billion (85.6 trillion won) last year, almost twice the market size of other vaccines measured at $33 billion. The global COVID-19 vaccine market is expected to grow to $84.9 billion this year.

SK Bioscience pointed out that the demand for COVID-19 vaccine shots will increase in Europe as the European Center for Disease Prevention and Control and the EMA announced the recommendation of using second booster shots, or fourth administrations, for people aged 60 or older in July. SKYCovione is a recombinant protein-based COVID-19 vaccine candidate incorporated with global drug maker 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.

SK Bioscience conducted the final phase three 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. The results indicated that SKYCovione demonstrated superior immune responses in comparison to Vaxzevria, the control vaccine jointly developed by Oxford University and AstraZeneca, the company said.

The South Korean vaccine developer is also in the process of putting SKYCovione on the World Health Organization’s Emergency Use Listing in order to supply the vaccine to the global market through COVAX.

COVAX is a worldwide initiative led by global organizations such as the Coalition for Epidemic Preparedness Innovations and the World Health Organization. Its goal is to guarantee equitable access to COVID-19 vaccines for every country in the world.

“With the repeated appearance of COVID-19 virus variants, people across the world are still facing threats in their daily lives,” said Ahn Jae-yong, CEO at SK Bioscience, in a statement. 

“(SK Bioscience) will fulfill its role and responsibilities as a global vaccine hub through the global market entrance of internally developed vaccine and developing new platforms in coping with the endemic,” he added.