Varicella is an acute infectious disease caused by the Varicella-zoster virus. Although most cases have a mild course, the disease can still lead to serious complications such as skin and soft tissue infections, pneumonia, encephalitis, or sepsis, particularly in young children and individuals at higher risk.[1]

With the advancement of science, vaccine manufacturing technologies are continuously being improved to enhance product quality and minimize unnecessary components. Barycela – a second-generation, antibiotic-free varicella vaccine – is one of the products developed in line with this approach.

1. What is an antibiotic-free varicella vaccine?

During the manufacturing process of some vaccines, antibiotics may be used to help control the risk of bacterial contamination.

Any residual antibiotics in the finished product, if present, must be controlled within the permitted limits in accordance with applicable regulations.

An antibiotic-free varicella vaccine is a vaccine manufactured without the use of antibiotics throughout the production process. Removing this component may help minimize the risk of antibiotic-related hypersensitivity associated with residual antibiotics, while also aligning with the development of modern vaccine manufacturing processes.

Barycela, developed by GC Biopharma, is based on more than 30 years of research and experience in manufacturing varicella vaccines using the MAV/06 strain. The vaccine is produced using the MRC-5 human diploid cell line, applying a closed aseptic manufacturing process and single-use technology in accordance with GMP standards. This enables strict control throughout the manufacturing process without the need for antibiotics.[2]

2. Safety and efficacy standards meeting WHO requirements

Barycela has been included by the World Health Organization (WHO) in the list of vaccines that have received WHO Prequalification, effective from February 14, 2023.[3] This process involves assessment based on standards for quality, safety, efficacy, and the ability to meet requirements for use in immunization programs.

Some key features of Barycela include:

• Antibiotic-free: The vaccine is manufactured without the use of antibiotics, helping to minimize the risk of hypersensitivity associated with residual antibiotics.
• High immune response: A Phase III clinical study involving 515 healthy children aged 12 months to 12 years reported a seroconversion rate of 97.9% after Barycela vaccination. The immune response was non-inferior to that of the comparator vaccine using the Oka strain.[4]
• Required viral potency: Each 0.5 mL dose after reconstitution contains live attenuated varicella virus of the MAV/06 strain, with a minimum potency of 3,800 PFU, consistent with the registered formulation.[5]
• Single-dose presentation: The vaccine is formulated as a lyophilized product, reconstituted with sterile water for injection prior to use, and stored at 2–8°C.[3]

Currently, the second-generation MAV/06-strain vaccine is available in several countries, including Türkiye, Egypt, and Pakistan, and has been included in the National Immunization Program in South Korea.

3. Two-dose schedule for optimal protection

The second-generation varicella vaccine Barycela is indicated for children from 12 months to 12 years of age to provide active immunization against varicella. The recommended vaccination schedule consists of two doses:

• Dose 1: From 12 months of age
• Dose 2: Three months after the first dose (minimum interval of 4 weeks) to enhance the protective effect.[5]

Completing the full vaccination schedule and receiving the doses on time helps strengthen the immune response, enhance protection, and reduce the risk of breakthrough varicella following vaccination.

4. Where to receive Barycela varicella vaccination?

In Vietnam, Barycela is officially distributed by NAVIVA Group, an organization with more than 20 years of experience in the field of vaccines and biological products.

The vaccine is stored and transported through a cold-chain system, following required temperature conditions and professional procedures to maintain product quality throughout distribution to vaccination facilities.

Parents can take their children to hospitals, vaccination clinics, or vaccination centers that provide Varicella for pre-vaccination screening, consultation, and an appropriate vaccination schedule.

References

[1] Ministry of Health of Vietnam, Infectious Diseases, Medical Publishing House.
[2] Centers for Disease Control and Prevention, “Varicella (Chickenpox),” 2024.
[3] World Health Organization, “WHO Prequalification of BARYCELA Vaccine,” 2023.
[4] S. Y. et al., “Immunogenicity and safety of varicella vaccine,” Vaccine, Elsevier, 2021.
[5] Vietnam Association of Preventive Medicine, Recommended Immunization Schedule for All Ages in Vietnam, 2026.