#South Korea #Seongnam #SK bioscience #Varicella Vaccine #SKYVaricella

SK bioscience's Pioneering Journey in Varicella Vaccination

SK bioscience, a crucial player in the global vaccine industry, has recently made significant strides by submitting an Investigational New Drug (IND) application aimed at initiating a Phase 3 clinical trial for its new 2-dose varicella vaccine, SKYVaricella. This move not only aligns with the evolving global standards, which increasingly advocate for a two-dose regimen but also responds to the rising demand within the international vaccine market.

Set against a backdrop of changing vaccination needs, the Phase 3 trial is designed to evaluate the immunogenicity and safety of two doses of the SKYVaricella vaccine. Approximately 800 children aged between 12 months to 12 years will participate in the trial, with its completion targeted for the year 2027. The push for a 2-dose vaccination strategy stems from the recognition that while single-dose vaccines have successfully reduced varicella cases and complications, breakthrough infections can occur over time. Therefore, the aim is to provide a more robust and long-lasting immunity through a comprehensive vaccination approach.

In March 2025, the World Health Organization's Strategic Advisory Group of Experts on Immunization officially recommended adopting a 2-dose varicella vaccination strategy, thereby enhancing the demand in global vaccine procurement markets such as the Pan American Health Organization (PAHO). Countries like the United States have seen the significant benefits of implementing a 2-dose schedule since 2006, managing to cut varicella incidence by over 85%. Other nations, including Germany and Japan, have also integrated this regimen into their national immunization frameworks.

Launched in Korea in 2018, SKYVaricella achieved World Health Organization Prequalification (WHO PQ) certification the following year, making it the second varicella vaccine globally to secure this recognition, thereby facilitating entry into international procurement markets. Over five million doses have already been administered worldwide through various channels, including Korea’s National Immunization Program and international tenders supported by PAHO.

To further bolster production efforts, SK bioscience recently entered into a new supply agreement with PAHO for the period 2025-2027, further reinforcing its commitment to expanding its influence in the global varicella vaccine market. As global reports indicate, the varicella vaccine market is poised for substantial growth, projected to rise from USD 3.4 billion in 2024 to a whopping USD 6.3 billion by 2034, with an average annual growth rate of approximately 6.5%.

In a statement, Ryu Ji-hwa, head of the Development Department at SK bioscience, emphasized the significance of the new 2-dose varicella vaccine as a strategic addition to their pipeline. Ryu stated, “Our 2-dose varicella vaccine is a strategic pipeline that directly reflects updated international standards and rising market demand. Building on our WHO PQ-backed procurement experience and R&D achievements, we aim to complete development expeditiously and compete globally with reliable production and superior immunogenicity.”

About SK bioscience

Established with a mission to enhance public health globally, SK bioscience is an innovative vaccine and biotech company dedicated to the development and manufacture of vaccines that ensure equitable access worldwide. Leveraging cutting-edge technologies, the company seeks to promote human health from prevention to cure, working collaboratively with governments, regulatory agencies, healthcare providers, and medical experts. The collective effort by all SK bioscience colleagues underscores their commitment to delivering high-quality vaccines to those in need and advancing public health solutions worldwide.