Quality analysis of 2009 pandemic influenza A(H1N1) vaccines

VernacularTitle:中国甲型H1N1流感疫苗质量分析
Author: Shuzhen LIU ; Ming SHAO ; Zhen CHEN ; Liyong YUAN ; Ping QIU ; Jianfeng WANG ; Zhifang YING ; Zhongyu HU ; Yusheng PEI ; Changgui LI
Publication Type:Journal Article
Keywords: H1N1 iInfluenza vaccines; Lot release; Independent testing
From: Chinese Journal of Microbiology and Immunology 2011;31(7):653-656
CountryChina
Language:Chinese
Abstract: Objective To analyze the laboratory testing data of 2009 pandemic influenza A (H1N1) vaccines during lot release procedure, thus to know the overall quality status of this vaccines.Methods National Institutes for Food and Drug Control(NIFDC) carried out the laboratory test according to the specifications of each manufacture, and the results was analyzed and compared between manufacturer and NIFDC. Results 99.8% of vaccines batches were released by NIFDC, haemagglutinin contents were between 90% to 103 % of labeled values, and testing results slightly differ between manufactures and NIFDC,other items related to safety were all meet specifications. Conclusion The quality of H1N1 vaccines in China were satisfying, the lot release and independent test by NIFDC play important roles to ensure the vaccines' quality.