Stability of BCG vaccines

Area of Science:

• Vaccinology
• Microbiology
• Pharmaceutical Stability

Background:

• Bacillus Calmette-Guérin (BCG) vaccine is crucial for tuberculosis prevention.
• Current BCG vaccine formulations require specific storage conditions.
• Evaluating vaccine stability in alternative presentations is essential for wider accessibility.

Purpose of the Study:

• To assess the stability of freeze-dried BCG vaccine in amber vials with butyl rubber stoppers.
• To determine stability across different vial sizes (1, 10, 20, 50 doses).
• To evaluate stability at controlled temperatures (4°C and 37°C).

Main Methods:

• Freeze-dried BCG vaccine was packaged in amber vials sealed with grey butyl rubber stoppers.
• Vials of varying dose capacities were stored at 4°C and 37°C.
• Stability was assessed over defined time points (1, 10, 20, 50 days).

Main Results:

• The freeze-dried BCG vaccine demonstrated stability in the tested vial presentation.
• Stability was maintained at both 4°C and 37°C across all vial sizes.
• No significant degradation was observed under the study conditions.

Conclusions:

• The vial presentation of freeze-dried BCG vaccine is a stable product.
• This stable formulation is suitable for use in mass immunization campaigns.
• The findings support the potential for improved BCG vaccine logistics and delivery.