SK Bioscience’s SKYCovione, Korea's first locally developed Covid-19 vaccine, has shown cross-neutralizing activity against Omicron variant BA.1 as a booster shot administered after the primary vaccination, the company said Wednesday.
"Amid the rising possibility of the resurgence of Covid-19, we have high expectations that the homegrown vaccine could be a new key to quarantine,” it said.
According to SK Bioscience, the results of phase 1 and 2 clinical trials, conducted on 81 healthy adults who received a booster dose of SKYCovione seven months after the second dose of the vaccine, showed that the neutralizing antibody titers against the Omicron variant BA.1 were 25 times higher than the titers right after the second dose, and 72 times higher than the titers seven months after the second dose.
In addition to the phase 1 and 2 clinical trials, SK bioscience is conducting booster clinical trials for participants in the recent phase 3 clinical trial and those who have been vaccinated with other approved vaccines in Korea to prepare for wider uses of SKYCovione in the endemic era.
The company expects the global vaccine market to expand as experts worldwide call for additional Covid-19 vaccinations due to the resurgence of the Omicron variant.
"The world slowly recovers its daily life after the long Covid-19 pandemic, but new variants are constantly threatening humanity," SK Bioscience CEO Ahn Jae-yong said. "We will make utmost efforts to prepare for the endemic by accelerating the development of polyvalent vaccines and universal vaccines based on various platforms aside from conducting various clinical trials of SKYCovione."
SKYCovione received approval from the Ministry of Food and Drug Safety on June 29 as Korea's first Covid-19 vaccine.
SK Bioscience jointly developed the vaccine, which contains GSK’s pandemic adjuvant, through cooperation with the Institute for Protein Design at the University of Washington School of Medicine.
The Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) also funded the development of SKYCovione.
SKYCovione had shown an acceptable safety profile based on all clinical trial data available, with most of the adverse reactions after injection being mild or moderate and transient.
The results of phase 3 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 was about 33 times the titers before the injection and were three times the titers elicited by AstraZeneca's Vaxzevria, the control vaccine used in the study, two weeks after the second dose.
After receiving SKYCovione, 98.06 percent of participants seroconverted with neutralizing titers after immunization greater than four-fold at baseline.