GC Biopharma said on the 26th that its varicella vaccine "BARYCELA inj (hereinafter BARYCELA)" has received marketing authorization from Guatemala's Ministry of Public Health and Social Welfare. This is the first approval BARYCELA has received in a Latin American country.
The company said it plans to ramp up its expansion into individual Latin American countries, building on its prior supply experience through the Pan American Health Organization (PAHO).
BARYCELA is a live vaccine that uses the "MAV 06" strain developed in-house by GC Biopharma. A live vaccine is one that weakens a pathogen's virulence to induce an immune response in the body.
In particular, it is the world's first varicella vaccine that uses no antibiotics at all in the manufacturing process, a feature that fundamentally blocks the possibility of adverse reactions from antibiotic residues such as kanamycin, neomycin, and erythromycin.
Immunogenicity has also been confirmed. This is an indicator of how well a vaccine elicits an immune response in the body. In long-term follow-up clinical results, the seroconversion rate after BARYCELA inoculation was in the 99–100% range, and antibody persistence was shown to be on par with global leading products.
Recently, it was listed in the World Health Organization (WHO) position paper. The position paper is an official document that sets out recommendations for vaccine use and the scientific basis, indicating international recognition of its reliability. As a result, it received an evaluation on par with global vaccines based on the Oka strain, and cross-vaccination between different vaccines has become possible.
Lee Jae-woo, head of development at GC Biopharma, said, "This authorization is significant as the first marketing approval in Latin America," adding, "We will continue to strengthen BARYCELA's global presence based on differentiated product competitiveness."