GC Biopharma announced on the 14th that it received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) for an adult combined vaccine against tetanus, diphtheria, and pertussis (Tdap) for phases 1 and 2.
In this clinical trial, GC Biopharma plans to inoculate 120 healthy adults aged 19 to 64 with "GC3111B" to evaluate safety and immunogenicity. The goal is to complete the clinical trials by the end of 2026.
The Tdap vaccine is classified as a mandatory national vaccination, but all vaccines distributed in the country currently rely on imports. In particular, pertussis has a high secondary infection rate of about 80% within families, and the defensive immunity obtained through vaccination does not last more than 10 years, necessitating periodic vaccinations.
Previously, GC Biopharma succeeded in self-sustaining the Td vaccine (tetanus and diphtheria) for the first time in Korea in 2018. With support from the Ministry of Health and Welfare's vaccine commercialization technology development project, it is promoting the localization of the Tdap vaccine.
The company aims not only to obtain domestic product approval for GC3111B but also to supply to international organizations such as UNICEF and the Pan American Health Organization (PAHO) through the World Health Organization (WHO) prequalification certification in the future. This is part of a strategy to enhance national competitiveness through increased exports as well as vaccine self-sufficiency.
Lee Jae-woo, head of development at GC Biopharma, said, "GC3111B can be developed and produced independently for all antigens from raw pharmaceuticals, and particularly, it holds its own patents in the pertussis manufacturing process, allowing for complete vaccine self-sufficiency. We will accelerate the vaccine development process. "