GC Biopharma said on the 2nd that it received approval from the Ministery of Food and Drug Safety for a domestic phase 3 clinical trial plan (IND) for two doses of its varicella vaccine "Varicella."
Varicella is a live vaccine based on the "MAV/06" strain developed in-house by GC Biopharma. This trial will add Korea to the global study underway in Thailand and Vietnam, and will include 474 healthy children ages 12 months to 12 years. It will directly compare Merck's (MSD) varicella vaccine "Varivax" to evaluate immunogenicity and safety.
The global varicella vaccination market is moving to adopt a two-dose schedule as the standard to reduce "breakthrough infections" that occur after a single dose. Twenty-eight countries, including the United States, Canada and Japan, are already implementing a two-dose system, and the World Health Organization (WHO) also recommends two doses.
The MAV/06 strain underlying Varicella was listed in the "Position Paper," an official WHO document, in Nov. last year. As a result, it secured an international level of credibility equivalent to OKA strain–based varicella vaccines supplied by multinational pharmaceutical companies, and cross-vaccination between the two vaccines has been officially recognized.
GC Biopharma plans to obtain marketing authorization for the two-dose Varicella by 2028, focusing on Korea and major Southeast Asian countries after completing this multinational trial.
Lee Jae-woo, head of development at GC Biopharma, said, "The two-dose Varicella clinical trial is a key milestone to enhance the value of our vaccine portfolio," adding, "We will work to reduce the risk of breakthrough infections among children worldwide and expand utilization in global public procurement and the private vaccine market."