GC Biopharma announced on the 27th that it has submitted an Investigational New Drug (IND) application to Thailand’s Food and Drug Administration for a Phase 3 clinical trial of its chickenpox vaccine Barycela under a two-dose regimen. This marks the first time a Korean pharmaceutical company has advanced into a two-dose varicella vaccine clinical program.
The trial will enroll 474 healthy children aged between 12 months and 12 years. In particular, it is designed as a comparative study with Varivax, developed by U.S.-based Merck (MSD), the global leader in the chickenpox vaccine market, raising expectations that the competitiveness of Barycela will be objectively validated.
Globally, a two-dose regimen has become the standard for chickenpox vaccination. In fact, 28 countries, including the United States, Canada, Japan, and several European nations, recommend two doses to prevent infections that can occur even after a single vaccination. However, under Korea’s National Immunization Program (NIP), only a single dose administered at 12 months of age is mandated.
GC Biopharma aims to complete the Phase 3 trial by the second half of 2027. Upon completion, the company plans to pursue regulatory approvals for the two-dose regimen, focusing initially on Southeast Asian markets.
Barycela, which received marketing approval in Korea in 2020, was also approved in Vietnam last year. GC Biopharma plans to submit an IND for a two-dose Phase 3 study in Vietnam within this year.
Lee Jae-Woo, Head of Development at GC Biopharma, said, “This trial is an important milestone in establishing clinical evidence for the two-dose administration of Barycela,” adding, “It will enable us to build global vaccine competitiveness that aligns with standards in advanced markets.”
