GC Biopharma Corp. said on the 26th that its varicella vaccine “VARICELLAJU” has received marketing approval from the Ministry of Public Health and Social Assistance of Guatemala.
This marks the first time VARICELLAJU has secured regulatory approval in a Latin America country. The company said it plans to accelerate expansion into individual markets across the region, in addition to its existing supply through the Pan American Health Organization (PAHO).
VARICELLAJU is a live attenuated vaccine developed in-house by GC Biopharma using the proprietary MAV/06 strain.
Notably, it is the world’s first varicella vaccine manufactured without the use of antibiotics at any stage of production, eliminating the risk of adverse reactions caused by residual antibiotics such as kanamycin, neomycin and erythromycin, thereby maximizing product safety.
The vaccine has also demonstrated strong immunogenicity. Long-term follow-up clinical results showed that the rate of neutralizing antibody formation after vaccination reached 99% to 100%, with antibody persistence comparable to leading global products.
More recently, following its inclusion in a World Health Organization (WHO) position paper, the vaccine has received international recognition on par with global vaccines based on the Oka strain, enabling cross-prescription. This is expected to further expand the global application of VARICELLAJU.
Lee Jae-woo, head of development at GC Biopharma, said, “This approval is particularly meaningful as our first in Latin America,” adding, “We will continue to strengthen VARICELLAJU’s global presence based on its differentiated product competitiveness.”