GC Green Cross Publishes Study on 30 Years of Data for Independently Developed Varicella Vaccine Strain

Safety and Immunogenicity of MAV/06 Strain Proven
30 Million Doses Supplied Over 30 Years

GC Green Cross announced on March 11 that a comprehensive review paper analyzing the safety and immunogenicity of its independently developed varicella vaccine strain, 'MAV/06,' has been published in the SCIE-indexed international journal 'Human Vaccines & Therapeutics'.

This publication was a collaborative effort among researchers from GC Green Cross, Ajou University, and Sungkyunkwan University. The team systematically analyzed more than 40 studies, including clinical trial results, post-marketing safety reports, real-world vaccination data, and genomic analyses of the MAV/06 strain vaccine, published between 1991 and 2023.

According to the paper, the MAV/06 strain belongs to the same genetic lineage (Clade 2) as the Oka strain, which is used as the global standard, while also demonstrating distinct genetic characteristics separating it from wild-type viruses. This supports its safety as a vaccine.

Additionally, MAV/06 was shown to induce a broad immune response not only against Clade 2, but also Clades 1, 3, 5, and wild-type Clade 2 varicella viruses. This suggests that GC Green Cross's varicella vaccine may offer broad protection against various varicella virus variants found worldwide.

Furthermore, in numerous clinical trials involving infants, young children, and immunocompromised patients, the seroconversion rate for neutralizing antibodies after vaccination with the MAV/06-based varicella vaccine was found to be between 99% and 100%. Antibody persistence was also similar to that observed with the Oka strain-based vaccine.

An analysis of more than 30 years of real-world evidence showed that the adverse event rate for MAV/06-based varicella vaccine was between 0.41 and 0.57 cases per 100,000 doses, which is lower than that of major global vaccines.

Notably, GC Green Cross's second varicella vaccine, 'Varicella J,' is the world's first varicella vaccine produced without the use of any antibiotics during the manufacturing process, thereby eliminating the possibility of antibiotic-derived adverse events from substances such as Kanamycin, Neomycin, and Erythromycin.

To date, more than 30 million doses of MAV/06-based varicella vaccine have been supplied to over 20 countries. In 2023, 'Varicella J' obtained WHO Prequalification (PQ) certification, enhancing its competitiveness in the global public procurement market. Recently, the World Health Organization officially recognized the interchangeability of the Oka strain vaccine and MAV/06-based vaccine, which is expected to further expand its scope of use in global markets.

Choi Bongkyu, Head of the AID (AI & Data Science) Center at GC Green Cross, stated, "This review paper is significant because it academically synthesizes the safety and efficacy that the Korean varicella vaccine has demonstrated in the global market over the past 30 years." He added, "We will continue to contribute to improving the health of children worldwide, including in countries with limited access to vaccines."

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