PROTECTION OF THE DURATION OF THE NATIONAL STANDARD SAMPLE VACCINE FOR HERVEN B SECOND RECOMMENDATION

Abstract

The national standard of recombinant hepatitis B vaccine lot, code MCQG.HBV.02, has been in use since 2019 but there has been no stability studies published. This study was carried out with the aim of predicting the shelf life of the above national standard vaccine lot by accelerated stability testing to quantify the HBsAg antigen contents of the national standard vaccine lot at different storage temperatures: 25^oC, 37^oC and 45^oC. The results showed that, at 25^oC after 28, 56, and 84 days, the HBsAg contents of MCQG.HBV.02 lot were 28.8; 26.5 and 13.3 µg/ml respectively; at 37^oC after 28, 56 and 84 days, the HBsAg contents of vaccine lot were 17.4; 12.1 and 8.7 µg/ml respectively; at 45^oC after 7, 14, 28, 56 days, the HBsAg contents of vaccine lot were 15.4; 12.4; 5.8 and 3.3 µg/ml respectively. Using JMP Pro13 software based on the Arrhenius equation gave results that: the shelf life of natioanl standard vaccine lot was 1825 days (equivalent to 5.3 years); the HBsAg content is predicted to reach 20.4 µg/ml after 5 years that meets the requirements according to the standard ≥ 20 µg/ml. Conclusion: Predicted shelf life of the national standard of recombinant hepatitis B vaccine lot, code MCQG.HBV.02, is 5.3 years when stored at 2-8^oC.