GSK, SK bioscience seek approval of COVID vaccine SKYCovione in South Korea, after beating AstraZeneca's Vaxzevria in trial
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GlaxoSmithKline (NYSE:GSK) and SK bioscience submitted a biologics license application to the Korean Ministry of Food and Drug Safety (KMFDS) seeking approval of SKYCovione, following positive phase 3 data of the COVID-19 vaccine.
The companies said that both immunological superiority and non-inferiority of SKYCovione (GBP510/GSK adjuvant) was seen compared to AstraZeneca's (AZN) COVID-19 vaccine Vaxzevria (control vaccine).
GSK said SK bioscience carried out the phase 3 study trial in 4,037 adults over 18-year-old across 6 countries â Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.
The companies said that the vaccine showed superior neutralizing antibody titres over Vaxzevria.
SKYCovione, which is recombinant protein-based COVID vaccine containing GSKâs pandemic adjuvant, showed a clinically favorable safety profile, the companies noted in an April 29 press release.
GSK added that data showed a superior neutralizing antibody response of SKYCovione against SARS-CoV-2 parental strain, 2.93 times that of a control vaccine two weeks after the second dose.
In addition, the proportion of participants who seroconverted (developed specific antibodies), with a greater than four-fold increase in neutralizing antibody titres compared to baseline, was 98.06% in the SKYCovione group and 87.30% in the control group.
The companies added even in people aged 65 or older, the antibody conversion rate of those vaccinated with SKYCovione was over 95%, when compared to the control vaccine (about 79% for the same age group).
SK bioscience already has an agreement to supply 10M doses of SKYCovione to the Korea Centers for Disease Control and Prevention (KDCA).
GSK added that SK bioscience will apply for emergency use listing to the World Health Organization and in other countries.
If authorized, GBP510 could be made available to the COVAX facility for procurement and equitable allocation worldwide, if required.
SK bioscience is also conducting a homologous booster trial of SKYCovione in South Korea and a heterologous booster trial in the country and abroad.
The Adolescents trial between 12 years to 17-year-old is expected to enter a phase 3 stage in H1 2022.
In addition, the company has planned an extended trial to test the preventive effect of SKYCovione against variants such as Omicron.