The Trend Analysis and Quality Evaluation of Live Attenuated Yellow Fever Vaccine in China from 2011 to 2018

Abstract

To summarize the lot release of live attenuated yellow fever vaccine in China during 2011-2018 and evaluate the total quality as well as problem in quality control of the vaccine. By reviewing the data and laboratory test，34 batches of live attenuated yellow fever vaccine were determined for virus titer according to the standard for license, of which 52 batches were determined for ovalbumin residue by ELISA, and 14 batches for moisture. The determination results were subjected to statistical and quality trend analyses, and compared with those by the manufacturers，based on which the general status of vaccine quality was reviewed. All the determination results of virus titer, ovalbumin residue and moisture met the requirements in Chinese Pharmacopoeia, and there is no difference in those by the manufacturers and those by the National Institutes for Food and Drug Control . The quality of live attenuated yellow fever vaccine was stable, which met the requirements in Chinese Pharmacopoeia. The implementation of lot release, batch inspection and trend analysis may effectively regulate and supervise the vaccine production．