BARYCELA inj. is a varicella vaccine manufactured by GC Biopharma (South Korea). With more than 30 years of experience and a presence in over 30 countries, GC Biopharma is recognized as one of Asia’s leading and most reputable vaccine manufacturers.
1. A 30-Year Journey in Varicella Vaccine Development by GC Biopharma
GC Biopharma is a pioneer in South Korea in the research and production of varicella vaccines.
First-generation varicella vaccine (Varicella – MAV/06 strain):
- Licensed in South Korea since 1993
- Incorporated into the National Expanded Program on Immunization (EPI) in 2005
- More than 30 million doses administered, generating robust safety data
2. BARYCELA – Second-Generation MAV/06 Strain Varicella Vaccine with Enhanced Manufacturing Processes
BARYCELA was developed based on the first-generation platform, incorporating key advancements:
- Manufactured using an enhanced process that meets international standards
- Utilizes the WHO-recommended MRC-5 cell line
- Antibiotic-free, in compliance with FDA standards – Aseptic Processing
As of March 2025, GC Biopharma has:
- Supplied 2 million doses of BARYCELA to the international market
- Supplied 2.5 million doses to Brazil’s National Expanded Program on Immunization through PAHO
BARYCELA has been licensed in:
Pakistan (2022), Turkey (2024), Egypt, Libya, and Brazil (2025), and is currently undergoing registration in multiple other countries.
Image: BARYCELA – A Korean varicella vaccine free from antibiotics
3. Quality Standards in Accordance with the World Health Organization (WHO)
BARYCELA fully meets WHO standards for quality, safety, and efficacy, including:
- WHO Prequalification (WHO-PQ)
- Comprehensive inspection and evaluation under CGMP – Aseptic Processing standards
Reference documents:
https://extranet.who.int/prequal/vaccines/p/barycela-inj
https://extranet.who.int/prequal/sites/default/files/vwa_vaccine/pq_381_Varicella__GC_VPASR-WHOPAR-2023.pdf
4. Regulatory Dossier and Clinical Data in Vietnam
In accordance with regulations of the Ministry of Health of Vietnam, BARYCELA has:
- Had its prescribing information approved by the Drug Administration of Vietnam
- Completed a clinical study evaluating safety and immunogenicity (August 8, 2024)
- Received marketing authorization on July 7, 2025
- Been granted batch release certification on November 5, 2025 by the National Institute for Control of Vaccines and Biologicals
5. Key Advantages in Immunization Practice
a. Proven immunogenicity and safety
Controlled clinical studies demonstrate that BARYCELA has comparable immunogenicity and safety to the reference vaccine:
https://www.sciencedirect.com/science/article/abs/pii/S0264410X21001614
b. Antibiotic-free formulation
A distinguishing feature compared to most currently available varicella vaccines.
Manufactured in accordance with FDA Aseptic Processing standards.
c. 2.4-fold higher stability
Thanks to improved manufacturing processes, the minimum viral potency is maintained at ≥ 3,800 PFU, ensuring vaccine stability throughout its product lifecycle.
d. Cost-effective pricing to support expanded immunization coverage
BARYCELA is competitively priced, enabling vaccination providers to more easily expand services across diverse population groups. Affordable pricing encourages earlier vaccination in children, thereby increasing vaccine coverage, reducing outbreak risk, and lowering treatment burdens within the community.
6. Disease Burden and Complications of Varicella
According to data from the CDC and WHO, varicella is often mild but may cause serious complications even in otherwise healthy children, particularly in school settings.
Reported complications include:
- Skin and soft tissue infections (impetigo, cellulitis, abscesses)
- Acute cerebellitis, resulting in tremors and ataxia
- Encephalitis and meningitis
- Varicella pneumonia
- Permanent scarring due to extensive skin lesions
- Secondary attack rates of up to 80–90% among non-immune individuals
Vaccination remains the most effective intervention to reduce disease incidence, prevent complications, and limit outbreaks in schools and communities.
7. NAVIVA GROUP – Authorized Distributor of the Second-Generation MAV/06 Varicella Vaccine (BARYCELA inj., GC Biopharma – South Korea) in Vietnam
With more than 21 years of experience, NAVIVA Group is a trusted partner to healthcare facilities in the distribution of vaccines and biological products.
NAVIVA Group’s supply capabilities include:
- GDP-compliant cold chain storage and transportation systems in Hanoi, Da Nang, and Ho Chi Minh City
- A professional, well-trained workforce
- Communication support and post-marketing services for partners
NAVIVA Group is committed to ensuring a stable supply of high-quality vaccines, fully compliant with Ministry of Health regulations and manufacturer guidelines.
