COVID-19 vaccine SKYCovione has been applied

Prospects for commercialization in the second half of the year

Domestic Supply of 10 Million Inoculated

SKYCovione, a coronavirus vaccine developed by SK Bioscience

SK Bioscience announced on the 29th that it has applied for an item permit for the COVID-19 vaccine candidate GBP510.

 

SK Bioscience predicted that it will be able to commercialize it in the second half of the year after obtaining approval from the MFDS.

 

The name of the vaccine applied through item approval was SKYCovione Multi Injection.

 

If the MFDS approves the item license, SKYCovione will be the first COVID-19 vaccine in Korea.

 

SKYCovione's item approval is carried out through a rapid approval process for official item approval, not EUA.

 

If approval is completed, it is expected to be commercialized during the second half of the year.

 

In March, SK Bioscience signed a domestic supply contract with KDCA and SKYCovione for a total of 10 million doses.

 

SKYCovione is immunogenic with only one inoculation.

 

SKYCovione will be supplied around the world through COVAX Facility after obtaining a domestic item license.

 

In addition, SK Bioscience plans to register SKYCovione on the WHO Emergency Use List (EUL) and acquire EUA by foreign countries such as Europe.

 

SKYCovione is a synthetic antigen-type COVID-19 vaccine developed in collaboration with global organizations and companies centered on SK Bioscience.

 

Institute for Protein Design (IPD) and SK Bioscience jointly developed it.

 

From the early stages of development, it received funding from the Bill & Melinda Gates Foundation (BMGF) and the Infectious Disease Prevention Vaccine Union (CEPI).

 

In addition, GSK's Adjuvant (Adjuvant) AS03 was applied to increase the immune response and induce a high level of neutralizing antibodies.

 

SK Bioscience announced that it has confirmed excellent immunogenicity and safety in the recently completed phase 3 clinical trials.

 

Phase 3 clinical trials were conducted on 4,037 adults aged 18 or older in six countries, including Korea, Thailand, Vietnam, New Zealand, Ukraine, and the Philippines.

 

Vaxzevria, AstraZeneca's COVID-19 vaccine, was examined for the immunogenicity and safety of SKYCovione as a control vaccine.

 

As a result, it was found that all of them had superior immunogenicity and safety compared to Vaxzevria.

 

At the time of SKYCovione's second inoculation, neutralizing antibodies were formed 2.93 times higher than that of the control vaccine.

 

SKYCovione's antibody conversion rate (subjects with a quadruple increase in neutralizing antibodies after inoculation) was 98%, which was more than 10% higher than the antibody conversion rate of 87% of the control vaccine, showing a statistically significant difference.

 

Even in the elderly aged 65 or older, the antibody conversion rate of those who were vaccinated with SKYCovione exceeded 95%, showing a significant difference compared to the control vaccine (79% of the elderly antibody conversion rate).

 

The cellular immune response, which plays an important role in lowering the severity of COVID-19 infection, was also at the level of equal to or higher than that of the control vaccine.

 

In the case of safety, SKYCovione showed an abnormal response rate similar to that of the control vaccine.

 

It was confirmed that no special safety problems were reported during the clinical trial period.

 

SK Bioscience expects SKYCovione to give new vaccine options to some classes who refused to vaccinate the existing COVID-19 vaccine.

 

Unlike the existing COVID-19 vaccine with new technology, the synthetic antigen method has been widely used in various vaccines so far, proving its safety.

 

In addition, unlike existing mRNA vaccines that require ultra-low temperature storage, refrigerated distribution and long-term storage of 2-8 degrees will contribute to increasing vaccination rates in underdeveloped countries that do not have expensive ultra-low temperature facilities.

 

SK Bioscience plans to conduct additional clinical trials so that SKYCovione can be widely used in quarantine in the endemic era.

 

These include booster shot clinical trials for existing COVID-19 vaccinations, cross-vaccination booster shot clinical trials, clinical trials for adolescents, and extended clinical trials for mutant viruses such as omicrons.

 

In particular, phase 3 clinical trials for those aged 12 to 17 are expected to enter within the first half of the year.

 

Roger Connor, CEO of GSK's Global Vaccine Business Department, said, "As COVID-19 endemics are predicted, demand for vaccines that are easy to distribute is expected to continue to increase." He said, "SKYCovione, which combines GSK immune enhancers, will play a very important role in the prevention of the endemic era." Ahn Jae-yong, president of SK Bioscience, said, "It is a new feeling that the first COVID-19 vaccine in Korea has reached the final stage for release." He said, "We will do our best to continue to cooperate with global organizations and companies to become an innovative bio company that competes on the global stage without being complacent."