Recent news has emerged that GC녹십자's chickenpox vaccine, Berycella, has entered Phase 3 clinical trials in Korea to verify the efficacy of a two-dose regimen. This clinical trial, conducted with approval from the Korean Ministry of Food and Drug Safety, is considered a crucial step in aligning with the global trend of strengthening chickenpox prevention strategies from a single dose to two.

Objectives of the Phase 3 Clinical Trial

The primary goal of this clinical trial is to confirm whether a two-dose administration of Berycella generates sufficient immune response and is safe. The study will involve 474 healthy children aged 12 months to 12 years and will be conducted as a direct comparison with Merck (MSD)'s chickenpox vaccine, Varivax. This research expands the ongoing global study in Thailand and Vietnam to include Korea.

The Importance of Chickenpox Vaccination

Chickenpox is a common infectious disease among children, which can spread rapidly in group settings like daycare centers and schools. Breakthrough infections, where individuals get infected despite vaccination, also play a significant role in vaccination strategies. While a single dose helps reduce severe cases of chickenpox, immunity can wane over time, or it may not be sufficient to completely prevent outbreaks. For these reasons, many countries are transitioning to a two-dose vaccination system.

• Countries such as the United States, Canada, and Japan have implemented a two-dose vaccination system.
• A review published in an international academic journal in 2022 indicated that 28 countries utilize a universal two-dose vaccination system for infants and young children.

Berycella's Potential for Global Expansion

GC녹십자 plans to enter the global market with Berycella, based on the MAV/06 strain developed in 1993. Last November, the inclusion of the MAV/06 strain in the World Health Organization's (WHO) position paper on chickenpox vaccines provided a favorable basis for overseas clinical trials and regulatory approvals. However, inclusion in a WHO position paper does not immediately lead to approvals or changes in vaccination schedules in individual countries. Such decisions are made based on a comprehensive consideration of each country's disease burden, cost-effectiveness, and vaccine supply situation.

Future Plans and Vision

Following the completion of multinational clinical trials, GC녹십자 plans to pursue product approval for a two-dose regimen, focusing on Korea and key Southeast Asian countries. Lee Jae-woo, Head of GC녹십자's Development Division, emphasized that "the Berycella two-dose clinical trial is a key milestone to enhance the value of our vaccine portfolio," and stated that it aims to reduce the risk of breakthrough infections in children and increase its utility in global public procurement and the private vaccine market. We look forward to seeing what changes GC녹십자's efforts will bring to the future vaccine market.