GSK and SK BioScience Submit BLA in South Korea for COVID-19 Vaccine

GlaxoSmithKline (GSK) and South Korea-based SK Bioscience have submitted a Biologics License Application (BLA) in South Korea for their adjuvanted COVID-19 vaccine SKYcovione.

In a 4,037-participant late-stage study, the investigational vaccine demonstrated superior neutralizing antibody titres over AstraZeneca's COVID-19 vaccine, Vaxzevria, the companies said.

The neutralizing antibody response was 2.93 times that of the control vaccine two weeks after the second dose. And the proportion of participants with a greater than four-fold increase in neutralizing antibody titres compared to baseline was 98.06 percent in the SKYCovione group and 87.3 percent in the control group.

SK Bioscience said it also plans to submit emergency use applications to the World Health Organization and to regulatory agencies around the world.