GC Green Cross announced on the 27th that it has received approval from the Vietnam Ministry of Health for a Phase 3 clinical trial plan (IND) for the two-dose varicella vaccine “Varicella Vaccine Live (Varicella)” (2-dose schedule). After submitting the IND in November last year, the company communicated actively with local regulatory authorities and obtained approval to proceed with the clinical trial faster than initially expected.

For Varicella, prior to Vietnam, the company obtained approval for a Phase 3 two-dose IND in neighboring Thailand in October last year, and procedures such as the first patient in (FPI, First Patient In) on the 17th of this month are reportedly progressing smoothly.

This Phase 3 two-dose clinical trial targets healthy children aged from 12 months to under 12 years. The company plans to evaluate immunogenicity and safety after two doses of Varicella. It aims to secure the clinical results by next year. In particular, as the trial is designed to directly compare the product with Varivax from Merck & Co. (MSD) of the United States, a major global product, the company expects to be able to demonstrate objective product competitiveness.

GC Green Cross plans to enter the global two-dose varicella vaccine market starting with Southeast Asian countries from 2028. Globally, a two-dose schedule for varicella vaccination is becoming the standard. Twenty‑eight countries, including major markets such as the United States, Europe, and Japan, are implementing a two-dose regimen. The World Health Organization (WHO) also recently formalized its recommendation for two doses.

Lee Jae-woo, head of the GC Green Cross R&D Division, said, “Through successful clinical execution, the company will demonstrate the competitiveness of Varicella in the global standard two-dose vaccination setting.”

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