For live attenuated vaccines, stability is a critical quality attribute that helps ensure product integrity throughout storage, transportation, and administration. Because live viruses may gradually lose potency over time or when exposed to suboptimal storage conditions, maintaining vaccine stability is essential to preserving product quality.
The second-generation MAV/06 varicella vaccine – BARYCELA has been developed with advanced manufacturing technologies and is supported by robust stability data.
Image: BARYCELA Varicella Vaccine
Maintains a Minimum Potency of 3,800 PFU Throughout Its Shelf Life
BARYCELA maintains a minimum potency of 3,800 Plaque Forming Units (PFU) throughout its 24-month shelf life. This minimum potency is higher than that specified for certain Oka-strain varicella vaccines currently used worldwide (1).
| Second-generation MAV/06 | Oka/Merck | Oka/RIT | |
| Shell Life | 24 months | 24 months | 24 months |
| Minimum PFU | 3800 | 1350 | 1995 |
Table. Comparison of minimum PFU values among varicella vaccines
In a multicenter Phase III clinical study, BARYCELA demonstrated non-inferior immunogenicity and a comparable safety profile to the Oka/Merck varicella vaccine following vaccination (2).
Stability Data Under Storage at 15°C for 28 Days
According to manufacturer stability studies, BARYCELA was stored under the following conditions:
- Temperature: 15 ± 2°C
- Relative humidity: 65 ± 5%
- Protected from light
- Continuous storage for 28 days (2)
The study demonstrated that all critical quality attributes remained within predefined acceptance criteria through Day 28, including:
- Appearance
- Moisture content
- Product uniformity
- Viral identity
- Viral content (potency)
- pH
- Sterility
Although viral potency showed a gradual decline during storage at 15°C, all study batches continued to comply with the approved product quality specifications throughout the evaluation period (1).
Image: Vaccine stability — an essential factor in ensuring product quality.
Relevance to Immunization Practice
Maintaining the vaccine cold chain remains a fundamental requirement for all vaccination providers. However, the available stability data indicate that BARYCELA maintains its quality under the evaluated storage conditions, providing additional scientific support for vaccine quality management and quality assurance throughout routine immunization practice.
For healthcare professionals, these findings offer further scientific evidence regarding the product’s characteristics, reinforcing confidence in vaccine quality from manufacturing and distribution through to clinical use.
From Scientific Evidence to Clinical Practice
In addition to Phase III clinical evidence demonstrating non-inferior immunogenicity compared with Varivax, stability studies of the second-generation MAV/06 varicella vaccine further reflect the manufacturer’s commitment to product quality.
The ability to maintain a minimum potency of 3,800 PFU throughout the product’s shelf life, together with supportive stability data, represents important evidence supporting the quality of the vaccine before it reaches healthcare providers and vaccine recipients.
NAVIVA GROUP
“Community Health Is Our Happiness.”
Contact Information:
NAM HUNG VIET Vaccine & Biological Products Joint Stock Company
Address: No. 89, Nguyen Thi Thap Street, Him Lam Area, Tan Hung Ward, Ho Chi Minh City
Phone: 028 2223 2425
TUONG KHUE Pharmaceutical Joint Stock Company
Address: 33 Le Lai Street, Hai Chau Ward, Da Nang City
Phone: 0236 3538 666
WINBIO Joint Stock Company
Address: K7TT1 – SH19, Starlake Urban Area, Xuan Dinh Ward, Hanoi Capital
Phone: 024 3795 6789
