[Analysis and evaluation on quality of live attenuated measles vaccine from market surveillance sampling].
OBJECTIVE
To ensure the quality of live attenuated measles vaccine on the market, viral titers were determined as the market surveillance test.


METHODS
The measles vaccine was sampled from sites located in 24 provinces (cities, autonomous regions) of China, including provincial CDC, municipal CDC, county CDC, and primary users. The virus titer of samples was tested to evaluate the quality status of measles vaccine on the market.


RESULTS
For all the 54 lots of measles vaccine sampled in this study, the virus titers were in compliance with the requirements of the China Pharmacopeia Vol. III (2005 edition). In comparison with the original test results provided by the manufacturers, the mean virus titer was decreased 0.2 lg +/- 0.3.


CONCLUSIONS
Viral titers of measles vaccine batches sampled from the market were all in compliance with the requirements of the China Pharmacopeia Vol. III (2005 edition). It showed that the measles vaccine in China market has good stability, and the cold chain system for measles vaccine conveyance and storage could ensure the vaccine efficacy.
National Institute for the Control of Pharmaceutical and Biological Products, Beijing, 100050, China.
Han-hua
HH
Fang
Xiao-xin
XX
Wang
Min
M
Yi
D006801:Humans; D008458:Measles Vaccine / Q000009:adverse effects / Q000276:immunology / Q000592:standards / Q000600:supply & distribution; D008459:Measles virus / Q000276:immunology / Q000502:physiology; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D013997:Time Factors; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology / Q000592:standards / Q000600:supply & distribution; D019562:Viral Load / Q000276:immunology
D008458:Measles Vaccine; D014613:Vaccines, Attenuated