SK bioscience said it has voluntarily withdrawn its application for a conditional marketing authorization (CMA) license to the European Medicines Agency (EMA) for SKYCovion (Korean name: SKYCovione), the country's first locally-develop Covid-19 vaccine.

The withdrawal comes after one year and one month since the company submitted the CAM application on July 30 last year.

"Due to the shift in the pandemic situation and the recent recommendation by the World Health Organization (WHO) to target XBB strain for the upcoming winter vaccination, we have changed our strategy and voluntarily withdrawn the license application for SKYCovion, which is based on the original Wuhan strain," SK bioscience said in a public filing on Friday.

With the withdrawal of the conditional authorization, SK Bioscience's plans to supply SKYCovion to many European countries have gone up in smoke.

At the time of applying for the CMA in July last year, the company stressed that the characteristics of SKYCovion, which can be distributed under refrigerated conditions, may be of interest to many countries.

The company has also hoped that the EMA's CMA will serve as an opportunity to expand the license to other countries.

However, with the WHO's recent recommendation for an XBB strain-targeting Covid-19 vaccine, industry watchers have stressed that even if the conditional license is granted, it is unlikely that the vaccine will ever be used.

The company had faced a similar problem regarding controversies about the ineffectiveness of SKYCovione in Korea when the Omicron variant was in full swing in the second half of last year.

After the company received approval from the Ministry of Food and Drug Safety in June 2022, the market and the public were largely uninterested in the vaccine because many people had completed the basic vaccination and the pandemic mutated considerably from the original virus.

Despite no longer seeking approvals for SKYCovione, an SK bioscience official stressed that clinical trials for SKYCovione targeting various mutations will continue.

"We don't know how the materials will be used in the future, so the ongoing clinical trials will continue," the official told Korea Biomedical Review. "In addition, while the licensing process for SKYCovione has ended, the development of a vaccine targeting the mutation is ongoing."

Once developed, it will be submitted for approval under a different name, she added.