GC Biopharma review summarizes 30 years of MAV/06 varicella vaccine data
GC Biopharma said a review paper in Human Vaccines & Therapeutics analyzed more than 40 studies on its MAV/06 varicella vaccine strain. The paper summarized 30 years of data showing 99-100% neutralizing antibody rates and adverse event incidence of 0.41 to 0.57 cases per 100,000 doses.
GC Biopharma announced that a review paper comprehensively analyzing the safety and immunogenicity of its independently developed varicella vaccine strain, MAV/06, has been published in Human Vaccines & Therapeutics. The research team systematically analyzed more than 40 studies, including clinical trial results of the MAV/06 vaccine published between 1991 and 2023, post-marketing safety reports, real-world vaccination data, and genomic analysis data.
According to the paper, the MAV/06 strain belongs genetically to the same clade (Clade 2) as the Oka-derived vaccines well-known as the global standard, yet it shows distinguished feature from the wild-type virus, thereby proving its safety as a vaccine. MAV/06 was confirmed to induce a broad immune response not only against Clade 2 but also against Clades 1, 3, 5, and wild-type Clade 2 viruses.
Results from numerous clinical trials, including infants and immunocompromised patients, showed that the rate of neutralizing antibodies generated in the body after vaccination with the MAV/06-based varicella vaccine reached 99-100%, with antibody persistence similar to that of the Oka strain vaccine. The analysis of real-world data accumulated over 30 years showed that the incidence of adverse events for the MAV/06-based varicella vaccine was at a level of 0.41 to 0.57 cases per 100,000 doses, which is lower than that of major global vaccines.
The company said BARYCELA Inj., its second varicella vaccine, is the world's first varicella vaccine to use no antibiotics in its manufacturing process, fundamentally eliminating the possibility of adverse reactions derived from antibiotics such as Kanamycin, Neomycin, and Erythromycin. MAV/06-based varicella vaccines have been supplied to over 20 countries, with more than 30 million doses to date.
BARYCELA Inj. obtained World Health Organization Pre-Qualification certification in 2023, securing competitiveness in the global public procurement market. The company said the scope of its utilization in the global market is expected to expand with the World Health Organization officially recognizing interchangeability with Oka strain vaccines.