Neutralizing antibody titres against Omicron variant BA.1 after a booster dose of SKYCovione™ were 25 times the titers two weeks post vaccination with the primary series before the booster.

SKYCovione™ were authorized in June based on immunogenicity and safety data

SK bioscience is preparing for endemic stage based on additional clinical trials

SK bioscience announced on today that SKYCovione™, first Korean developed COVID-19 vaccine, has shown cross-neutralizing activity against Omicron variant BA.1 following booster vaccination administered ~7 months after the primary series.

The results of the Phase I/II clinical trial, conducted with 81 healthy adults who received a booster dose of SKYCovione™ 7 months after the second dose of SKYCovione™, showed that the neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titres right after the second dose, and 72 times the titres 7 months after the second dose.

SKYCovione™, which has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS) on June 29th, is Korea´s first COVID-19 vaccine developed through global network cooperation led by SK bioscience. SKYCovione™ has been jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine and contains GlaxoSmithKline (GSK)’s pandemic adjuvant. The development of SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

SKYCovione™ has an acceptable safety profile based on all clinical trial data available. Most of the adverse reactions that occurred after injection were mild or moderate and transient.

The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione™ induced neutralizing antibody responses against the SARS-CoV-2 parental strain that were about 33 times the titers before the injection and were 3 times the titers elicited by AstraZeneca´s Vaxzevria™, the control vaccine used in the study, 2 weeks after the second dose.

After receiving SKYCovione™, 98.06% of participants seroconverted (with neutralizing titers after immunization greater than four-fold the titers at baseline).

In addition to the Phase I/II clinical trials, SK bioscience is conducting booster clinical trials not only for participants in the recent Phase III clinical trial but also for those who have been vaccinated with other approved vaccines in Korea in order to prepare for wider uses of SKYCovione™ in the endemic era.

In particular, the global vaccine market is expected to expand further as experts around the world are asking for additional COVID-19 vaccinations due to the resurgence of the Omicron variant. According to‘Our World In Data,’ the average number of new infected cases in the world on July 10th were 894,000 which was doubled versus the previous month.

In Korea, the number of new COVID-19 confirmed patients on July 12th exceeded 37,360 which was doubled versus the previous week.

The COVID-19 epidemic has shifted from a decline to an increase, and health authorities have recommended vaccinations as the COVID-19 epidemic is expected to occur again as early as this summer.

Jaeyong Ahn, CEO of SK Bioscience, said, "As the world slowly recovers its daily life after the long COVID-19 pandemic, new variants are constantly threatening humanity," adding, "We will make utmost efforts to prepare for the endemic by accelerating the development of polyvalent vaccines and universal vaccine based on various platforms in addition to conducting various clinical trials of SKYCovione™."