Phase 3 clinical plan for SK Bioscience's booster shot approved in Colombia

SK Bioscience Co., a leading South Korean vaccine and biotech company, announced on Monday that its phase 3 clinical trial plan for a heterogeneous booster shot of the COVID-19 vaccine, GBP510 or SKYCovione, had been approved by Colombian health authorities.

GBP510 is a synthetic antigen-based COVID-19 vaccine developed in collaboration with the University of Washington School of Pharmacy. It was approved by the Korean Ministry of Food and Drug Safety last year as the country's first domestic COVID-19 vaccine.

The phase 3 clinical trial will involve 840 adults in Colombia who have already received two doses of a previously approved COVID-19 vaccine. They will receive a third vaccination of GBP510 to evaluate its immunogenicity and safety.

SK Bioscience submitted its clinical plan application to Colombian health authorities in November last year.

Write to Jung-Eun Kim at likesmile@hankyung.com