SK Bioscience's homegrown COVID vaccine gets nod in UK

SK Bioscience announced on Tuesday that its COVID-19 vaccine SKYCovione received approval from the UK Medicines and Healthcare products Regulatory Agency.

SKYCovione has been approved for first and second primary series doses for adults aged 18 and over in England, Scotland and Wales, SK Bioscience added.

SKYCovione is a recombinant antigen-based COVID-19 vaccine, jointly developed with the Institute for Protein Design at the University of Washington. The vaccine also contains GlaxoSmithKline’s pandemic adjuvant used to increase immune response.

The approval came 14 months after the MHRA started its rolling review in March last year. With the latest approval, SKYCovione has become the eighth COVID-19 vaccine to be approved in the UK. The SK Bioscience COVID-19 vaccine is also the first Korean COVID-19 vaccine to be approved in the country.

SK Bioscience said the company will increase its efforts to receive additional approval from the European Medicines Agency and also seek the vaccine's WHO emergency use listing, a procedure assessing the suitability of novel health products during public health emergencies.

“The goal is to boost COVID-19 vaccine coverage in the world, including 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," an official from SK Bioscience said.

SK Bioscience said SKYCovione could become a competitive option in the COVID-19 vaccines market as several countries are moving to make COVID-19 vaccinations more like the annual flu shot.

Currently, the US, Japan, Australia and South Korea are actively discussing to update COVID-19 vaccines once a year, according to SK Bioscience.

SK Bioscience added its SKYCovione is one a good candidate to be a yearly shot as recombinant antigen-based vaccines are proven to be safer than other vaccines with relatively shorter lengths of safety data.

The company added its recombinant antigen-based vaccine – which can be refrigerated at between 2 and 8 degrees Celsius, is easier to handle and transport compared to other COVID-19 vaccines that require ultralow temperature storage.

SK Bioscience President & CEO Ahn Jae-yong said, “The latest approval will provide new momentum to SKYCovione to gain a solid footing in the COVID-19 vaccines segment, which has been expected to become increasingly uncertain in the endemic stage,” particularly for vaccines that were developed and launched later.

Meanwhile, SK Bioscience said the company will continue developing its own COVID-19 vaccine targeting the novel coronavirus and its variants, a pan-sarbecovirus vaccine, together with the Coalition for Epidemic Preparedness Innovations.