SK Bioscience announced that Korea’s first COVID-19 vaccine developed by the company shows neutralizing antibody cross-reactivity to the omicron mutation (BA.1) when administered with a booster shot. As the possibility of another COVID-19 infection spreading this summer increases, attention is being paid to whether the domestic COVID-19 vaccine will be the key to new quarantine.
SK Bioscience analyzed the cross-neutralizing ability of the booster shot through an extended phase 1/2 clinical trial study of ‘SKYCovione Multi Injection’, a synthetic antigen-based COVID-19 vaccine, and found that the immune response to omicron mutations confirmed.
As a result of additional vaccination with Skycovidone about 7 months after the basic vaccination (2 doses) of 81 healthy adults, neutralizing antibodies that neutralize the infectivity of Omicron virus and induce a preventive effect were found. It was found that the number increased about 25 times compared to immediately after the second vaccination. Also, compared to 7 months after the second vaccination (right before the booster shot), it was about 72 times higher.
SkyCoViOne has previously proven its immunogenicity and safety through global clinical trials. As a result of a global phase 3 clinical trial targeting 4,037 adults aged 18 years or older, the antibody conversion rate, which refers to the proportion of subjects whose neutralizing antibodies increased more than 4-fold after vaccination, was confirmed to be more than 98%. In addition, neutralizing antibodies also increased about 33 times compared to before vaccination, and neutralizing antibodies were formed about 3 times higher than the control vaccine.
In terms of safety, it showed a similar level of adverse reaction rate compared to the reference vaccine, and no special safety issues were reported during the clinical trial period. SkyCoViOne’s global clinical trials and clinical analysis received support from the non-profit international organization IVI (International Vaccine Institute) and the Public Vaccine Development Support Center of the National Institute of Health, and domestic clinical trials were conducted at a number of institutions, including Korea University Guro Hospital.
In addition to this phase 1/2 extension study, SK Bioscience is conducting an extension study of the existing phase 3 clinical trial and a booster shot clinical trial targeting recipients of other previously approved COVID-19 vaccines to determine the effectiveness of responding to additional omicron mutations. We are verifying the possibility of various uses of Skycobee One in the endemic era. In particular, as experts around the world are urging additional COVID-19 vaccinations due to the resurgence of Omicron, its marketability is expected to expand further.
SK Bioscience President Ahn Jae-yong said, “As the world is slowly returning to daily life after the long COVID-19 pandemic, new mutations are constantly threatening humanity,” and added, “In addition to SkyCoViOne’s various clinical trials, we are developing a multivalent drug using the platform.” “We will do our best to prepare for the pandemic by accelerating the development of vaccines and universal vaccines,” he said.
Meanwhile, ‘SKYCOVIONE’, which obtained product approval from the Ministry of Food and Drug Safety on the 29th of last month, is Korea’s first COVID-19 vaccine developed through cooperation with various global networks led by SK Bioscience. It was jointly developed by SK Bioscience and the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy, and was supported throughout all stages of development by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Prevention and Vaccines (CEPI). received. In addition, GlaxoSmithKline (GSK)’s adjuvant AS03 was applied to strengthen the immune response and induce high levels of neutralizing antibodies.
Source: Pangyo Techno Valley Official Newsroom
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