STUDY ON THE STABILITY OF THE COVIVAC VACCINE FOR COVID-19 PREVENTION

Abstract

The stability study of the COVIVAC vaccine for COVID-19 prevention is an important requirement to ensure the vaccine's quality meets the necessary standards for administration to the public. The COVIVAC vaccine's stability was evaluated following the guidelines of the World Health Organization (WHO), the Vietnam Pharmacopoeia, and internal standards. This stability study was conducted on three batches of the vaccine candidate for clinical trial testing under two conditions: accelerated (25 ± 2°C and 37 ± 2°C) and real-time (5 ± 3°C) conditions. The evaluation included parameters such as visual appearance, pH, S protein antigen content, sterility, total protein, and endotoxin. The study results showed that after 15 months of storage at 5 ± 3°C and 14 days under accelerated conditions, all three batches of the finished vaccine maintained their quality. There were no statistically significant differences in the tested parameters (p > 0,05).