SK Bioscience Submits Phase 3 IND for Two-Dose Varicella Vaccine

Targeting Approximately 800 Children Aged 12 Months to 12 Years Domestically and Internationally

SK Bioscience has begun strengthening the competitiveness of its proprietary vaccines to expand its presence in overseas markets.

SK Bioscience Varicella Vaccine Skyvaricella Export Product. SK Bioscience

On September 2, SK Bioscience announced that it had submitted a global Phase 3 clinical trial IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for the addition of a two-dose (2-dose) indication for its independently developed varicella vaccine, Skyvaricella. This clinical trial will administer two doses to approximately 800 children aged 12 months to 12 years, both domestically and internationally, to evaluate immunogenicity and safety, with the goal of completion by 2027.

Since its domestic launch in 2018, Skyvaricella became the second vaccine in the world to receive WHO PQ certification the following year, enabling its entry into the international procurement market. It has been administered to over 5 million people worldwide and has expanded its supply through Korea’s National Immunization Program, private medical institutions, and international public tenders such as those from the Pan American Health Organization (PAHO). Most recently, SK Bioscience signed an additional long-term supply contract with PAHO for the years 2025 to 2027.

SK Bioscience plans to accelerate its entry into the global varicella vaccine market through the development of the two-dose regimen for Skyvaricella.

Varicella vaccines have effectively reduced the incidence and complications of chickenpox with a single dose, making the one-dose regimen the standard in many countries. However, as some breakthrough infections can occur over time after a single dose, international standards are now shifting toward a two-dose regimen to provide stronger and longer-lasting immunity and to block community transmission.

In fact, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) officially recommended a two-dose varicella vaccine regimen in March of this year. As a result, demand in international procurement markets, including PAHO, is rapidly increasing. The United States introduced the two-dose regimen in 2006, resulting in a reduction of varicella incidence by more than 85%, and major countries such as Germany and Japan have also incorporated the two-dose schedule into their national immunization programs.

According to market research firm Global Market Insights, the global varicella vaccine market is expected to grow from approximately $3.4 billion (about 4.7 trillion won) last year to around $6.3 billion (about 8.8 trillion won) by 2034, with an average annual growth rate of 6.5%.

Ryu Jihwa, Head of Development at SK Bioscience, stated, "The two-dose varicella vaccine is a strategic pipeline that is being rapidly developed based on our WHO PQ-based international procurement experience and R&D achievements. We aim to complete development in a short period of time, leveraging production stability and excellent immunogenicity, and to compete in the global market."

This content was produced with the assistance of AI translation services.