The stability observation of domestic Measles, Mumps and Rubella combined vaccine, live

Abstract

Objective To observe the stability of domestic Measles, Mumps and Rubella combined vaccine, live (MMR vaccine). Methods Twenty-four lots of MMR vaccines produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) in 2008-2017 were tested according to MMR vaccine registration standards approved by China Food and Drug Administration and related regulations in Chinese pharmacopoeia. The thermostability test was performed in month 0. The identity test and tests for appearance, moisture content, sterility, abnormal toxicity, residual bovine serum albumin, residual antibiotics (lots after October 2010), bacterial endotoxin (lots after December 2013), pH and osmolarity (lots after December 2015) were performed in months 0 and 18. The virus titration was performed in months 0, 6, 12 and 18. Accelerated and long-term stability tests were performed at the same time for 3 lots each of MMR vaccines produced in new and old workshops. The key examination items were moisture content and virus titer. Results All testing results of MMR vaccine met the registration standards and relevant regulations within the period of validity. The qualities of products by new and old workshops were comparable. The moisture content was ≤3.0%, and the virus titers of measles, mumps and rubella were 3.3-4.3, 4.6-5.6 and 3.3-4.3 lg 50% cell culture infective dose/ml, respectively. Conclusion The MMR vaccines produced by SIBP in 2008-2017 are safe and effective with stable quality. Key words: Measles-mumps-rubella vaccine; Stability; Virus titration