GC Biopharma announced on the 27th that it has submitted the clinical phase 3 trial plan (IND) for its varicella vaccine 'Barycela' for a two-dose (2 vaccinations) regimen to the Food and Drug Administration of Thailand.
This is the first time a domestic pharmaceutical company has entered into a two-dose clinical trial for the varicella vaccine. The trial will be conducted on 474 healthy children aged 12 months to under 12 years. Notably, it will compare the results directly with the Varivax vaccine from the leading global varicella vaccine market player, Merck (MSD).
Globally, the two-dose varicella vaccination has become the standard. In 28 countries worldwide, including advanced countries such as the U.S., Canada, Japan, and several European nations, two vaccinations are recommended to prevent breakthrough infections after a single dose.
The company plans to complete the clinical phase 3 trials by the second half of 2027. The company stated, "Once the trials are completed, we will proceed with the two-dose product approval, focusing on Southeast Asian countries." It also plans to submit the IND for the phase 3 trial of the Barycela two-dose vaccine in Vietnam within this year.
Lee Jae-woo, head of development at GC Biopharma, noted, "This trial is a significant milestone in establishing the evidence for the two-dose regimen of the Barycela vaccine," adding that it will enable the company to possess global vaccine competitiveness that meets advanced market standards.