LOS ANGELES, CA, July 27, 2022 /24-7PressRelease/ -- SK Bioscience announced that Korea's no. 1 Covid-19 vaccine developed by the company shows a neutralizing antibody responses to the omicron variant (BA.1) when inoculated with a booster shot. With the possibility of another spread of COVID-19 this summer, attention is being paid to whether the domestic COVID-19 vaccine will be key to a new quarantine measure.
SK Bioscience analyzed the cross-neutralization of booster shots through an extended study of phase 1/2 clinical trials of "SKYCovione GBP510," a synthetic antigen-type COVID-19 vaccine, and confirmed the immune response to the omicron variant.
81 healthy adults got additional vaccination about seven months after getting two doses of basic vaccination of SKYCovione. It turns out the number of neutralizing antibodies that can induce preventive effects by neutralizing omicron infection increased by about 25 times compared to immediately after the primary series. In addition, it was about 72 times higher compared to seven months after the final dose in the primary series(right before a booster).
SKYCovione has previously proven its immunogenicity and safety through global clinical trials. In phase 3 global clinical trials of 4,037 adults aged 18 or older, it was confirmed that the antibody conversion rate, meaning the proportion of subjects whose neutralizing antibodies increased more than four times after vaccination, was 98% or higher. Neutralizing antibodies also increased about 33 times compared to before inoculation, and about three times more neutralizing antibodies were formed than those of the control vaccine.
In terms of safety, there was a similar level of adverse reaction rate compared to the control vaccine, and no special safety problems were reported during the clinical trial. SKYCovione's global clinical trial and clinical analysis were supported by IVI (International Vaccine Institute), a not-for-profit international organization and the National Institute of Health's Korea Vaccine Research Center, and domestic clinical trials were conducted at Korea University Guro Hospital.
In addition to the 1/2 phase extension study, SK Bioscience is verifying the possibility of SKYCovione's various uses in the endemic era by conducting extension studies of existing three-phase clinical trials, conducting booster shot clinical trials of people vaccinated with other previously approved COVID-19 vaccines, in order to confirm the effectiveness against additional omicron variants. In particular, the market is expected to expand further as experts around the world are asking for additional COVID-19 vaccinations due to the re-emergence of the omicron variant.
Ahn Jae-yong, CEO of SK Bioscience, said, "As the world is slowly getting back to pre-pandemic normalcy after the prolong COVID-19 pandemic, new variants are constantly posing a threat to humanity," adding, "We will do our best to prepare for the endemic era by accelerating the development of multivalent vaccines and universal vaccines using the platform as well as various clinical trials testing SKYCovione."
Meanwhile, "SKYCovione," which obtained approval from the Ministry of Food and Drug Safety in South Korea on the 29th of last month, is South Korea's first COVID-19 vaccine developed through various global networks and cooperation led by SK Bioscience. It was jointly developed by SK Bioscience and the Institute for Protein Design (IPD) of the University of Washington, and supported by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) throughout the entire development. Also, GlaxoSmithKline (GSK)'s immune-enhancer AS03 was applied to strengthen the immune response and induce a high level of neutralizing antibodies.
Source: Pangyo Techno Valley Official Newsroom
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