GC Biopharma Secures Major Approval for Varicella Vaccine Launch in Guatemala

GC Biopharma, a prominent provider of biopharmaceutical products based in South Korea, recently achieved a significant milestone in its mission to improve public health. The company announced that its varicella vaccine, named BARYCELA Inj., has been granted marketing authorization by the Ministry of Public Health and Social Assistance (Ministerio de Salud Pública y Asistencia Social) in Guatemala. This approval represents the first regulatory clearance for its varicella vaccine in Latin America, paving the way for enhanced accessibility to quality immunizations across the region.

BARYCELA Inj. differentiates itself in the market through its unique production process. It is developed as a live attenuated vaccine using the proprietary MAV/06 strain and notably stands out as the world’s first varicella vaccine manufactured entirely without the use of antibiotics. The elimination of antibiotics such as kanamycin, neomycin, and erythromycin during its production process effectively mitigates potential adverse reactions linked to antibiotic residues. This innovative approach delivers a significantly enhanced safety profile, particularly for pediatric populations.

In addition to its safety benefits, BARYCELA Inj. recently gained further recognition after being included in a World Health Organization (WHO) position paper. The vaccine has been noted for its interchangeability with existing Oka strain-based vaccines, broadening its clinical utility on a global scale. This endorsement not only elevates BARYCELA’s acceptance among healthcare providers but also allows seamless integration into various national immunization programs, increasing its presence in international markets.

Jae Woo Lee, the Head of Regulatory Science and Product Development at GC Biopharma, expressed his enthusiasm for this achievement. He stated, "Securing this first marketing authorization in Latin America is a testament to the global competitiveness of our vaccine technology. We are committed to strengthening our position in the global market by providing a differentiated and safer preventive solution to healthcare systems worldwide."

The demand for varicella vaccines has been on the rise due to increasing awareness of health risks associated with chickenpox. By successfully launching BARYCELA Inj. in Guatemala, GC Biopharma aims to extend this life-saving immunization to neighboring markets, thereby contributing to the reduction of varicella-related morbidity and mortality.

About GC Biopharma
Founded as Green Cross Corporation, GC Biopharma has established itself as a key player in the biopharmaceutical industry over its more than fifty years of experience. Based in Yongin, South Korea, the company specializes in the research, development, and manufacturing of plasma derivatives and vaccines. In 2024, it made its successful entry into the US market with Alyglo® (intravenous immunoglobulin G) and has continued to innovate in the field of healthcare. By focusing on the engineering of proteins, mRNAs, and lipid nanoparticle drug delivery platforms, GC Biopharma aims to address the treatment needs for rare diseases and immunological conditions.

As GC Biopharma ventures into new markets with its varicella vaccine, it is poised for further growth and expansion while enhancing global public health. The company continues to commit substantial resources towards research and development efforts, ensuring that innovative solutions remain at the forefront of its agenda. To learn more about GC Biopharma and its array of products, visit their official website.