Quality analysis of 2009 pandemic influenza A(H1N1) vaccines / 中华微生物学和免疫学杂志
Chinese Journal of Microbiology and Immunology
;
(12): 653-656, 2011.
Artigo
em Chinês
| WPRIM
| ID: wpr-419530
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
Chinese Journal of Microbiology and Immunology
Ano de publicação:
2011
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS