SK Bioscience said on Tuesday that its homegrown Covid-19 vaccine, SKYCovione, obtained approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for the first and second primary series doses for adults aged 18 and over in England, Scotland, and Wales.

Consequently, SKYCovione is now the eighth Covid-19 vaccine to receive full authorization in the U.K.

SKYCovione is a synthetic antigen-based Covid-19 vaccine jointly developed with the Institute for Protein Design (IPD) at the University of Washington (UW) together with GlaxoSmithKline's (GSK) adjuvant to strengthen the immune response and induce neutralizing antibodies.

Under the MHRA's rolling review for accelerated approval, and based on phase 3 clinical trial data, it received formal approval in just one year and two months. Additionally, SK Bioscience aims to obtain WHO Emergency Use Listing (EUL) and European Medicines Agency (EMA) marketing authorization to lead the epidemic prevention of Covid-19, said a company official.

Currently, annualization of the Covid-19 vaccine is being actively discussed in the U.S., Japan, and Australia, and the Korean government has also announced its intention to make the Covid-19 vaccine available once a year like the influenza vaccine.

In particular, SKYCovione is expected to display market competitiveness as it applies a similar synthetic antigen method also used in annual influenza vaccines which have long-term safety data.

Moreover, compared to other Covid-19 vaccines which require ultra-low temperature storage and distribution, SKYCovione can be refrigerated at 2-8 degrees. Consequently, this expands access to low-and middle-income countries where presently 70 percent of the population in low-income countries still has not received a single dose of the Covid-19 vaccine.

It is also the world's first vaccine to be developed through RoseTTAFold, a deep-learning protein structure prediction and analysis program developed by UW which quickly and accurately decodes protein three-dimensional structures.

"Despite the end of the Covid-19 pandemic, we still believe that Covid-19 vaccines are necessary for protecting global public health," said SK Bioscience President & CEO Ahn Jae-yong. "We are grateful to our employees for their diligence and are confident that this approval will provide momentum to solidify our global market position in the pandemic transition."

SK Bioscience is currently also accelerating the development of a universal vaccine targeting Covid-19 and its variants, sarbecovirus, with support from CEPI.