Domestic COVID-19 Vaccine Takes First Step Toward Global Market

Obtained UK MHRA Approval
Expecting WHO and EMA Approvals
Aiming for Global Expansion Leveraging Synthetic Antigen Features

SK Bioscience's domestically developed COVID-19 vaccine, 'Skycovione' (European name: Skycovion), has taken its first step into the global market by receiving approval in the United Kingdom.

SK Bioscience's recombinant protein COVID-19 vaccine 'Skycovione' [Photo by SK Bioscience]

On the 30th, SK Bioscience announced that Skycovione had obtained formal approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for primary vaccination (1st and 2nd doses) in adults aged 18 and over in the UK, Scotland, and Wales. It became the eighth COVID-19 vaccine approved in the UK.

Skycovione is a synthetic antigen-based COVID-19 vaccine independently developed by SK Bioscience leveraging its global network. It was co-developed with the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy, USA, and employs GlaxoSmithKline (GSK)'s adjuvant 'AS03' to enhance immune response and induce neutralizing antibodies.

Notably, the MHRA is known as a stringent regulatory authority alongside the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company stated, "We have obtained approval for the first domestically developed vaccine in the UK, which has one of the highest standards for pharmaceutical approval globally, including the US and Europe," and added, "This recognizes our world-class technological capabilities." It is very rare even across the entire domestic pharmaceutical industry to independently conduct the entire process from candidate discovery to clinical trials and receive MHRA approval.

Skycovione began a rolling review for expedited approval by the MHRA in March last year, prior to receiving approval from the Korean Ministry of Food and Drug Safety in June last year. Based on Phase 3 clinical trial results, it received formal approval in just 1 year and 2 months. Additionally, the company has secured EMA marketing authorization applied for in August last year and inclusion in the World Health Organization (WHO) Emergency Use Listing (EUL) applied for in September, aiming to lead epidemic control in the COVID-19 endemic era and contribute to smooth vaccine supply in low- and middle-income countries (LMICs). With active discussions on annual COVID-19 vaccinations ongoing in the US, Japan, Australia, and the Korean government announcing plans to administer COVID-19 vaccines once a year like influenza vaccines, there is an expectation that market sustainability is achievable.

Researchers are conducting studies at the SK Bioscience Research Center in Pangyo, Seongnam-si, Gyeonggi Province, where Korea's first domestic COVID-19 vaccine, 'Skycovione,' was developed.
[Photo by Ministry of Health and Welfare]

Especially if entry into LMICs is realized, Skycovione is expected to have a competitive advantage in the market due to its manufacturing method. Skycovione uses a synthetic antigen approach, which has been proven safe in existing influenza vaccines. Unlike some COVID-19 vaccines that require expensive frozen cold chain systems, it can be stored and distributed under refrigerated conditions (2?8°C). Since vaccines requiring cold chains were developed intensively during the early COVID-19 pandemic, as of May, 70% of people in underdeveloped countries have yet to receive even a single vaccine dose. Therefore, it is expected to be actively used for epidemic control in the endemic era in LMIC markets that lack ultra-low temperature facilities.

Jae-yong Ahn, CEO of SK Bioscience, said, “Although there was uncertainty with questions about the necessity of vaccines as the COVID-19 pandemic ended, we have come this far driven by the belief in protecting global public health. I am grateful to the employees who trusted and worked hard despite difficult circumstances, and I am confident that this approval will be a momentum to solidify our global market position in the new phase of the endemic transition.”