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enterovirus 71 inactivated vaccine (human diploid cells)
- Development stage
- Unknown
- Lead developer
- Institute of Medical Biology Chinese Academy of Medical Sciences
- Modality
- Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
The Enterovirus 71 Inactivated Vaccine (Human Diploid Cells) is a monovalent inactivated vaccine developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS). The vaccine is produced using the FY-23K-B strain of Enterovirus 71 (EV71), belonging to the C4 sub-genotype, which is cultured in the KMB-17 human diploid cell line. Following purification and formalin inactivation, the viral antigen is adsorbed onto an aluminum hydroxide adjuvant. It is indicated for the prevention of hand, foot, and mouth disease (HFMD) and other infections caused by EV71 in children aged 6 months to 5 years. Clinical studies have demonstrated a protective efficacy of approximately 97% against EV71-associated HFMD. The vaccine was licensed by the China Food and Drug Administration (CFDA) in December 2015 and officially launched in March 2016.
- Other names
- Enterovirus 71 (EV71) Inactivated Vaccine (human diploid cells)肠道病毒71型灭活疫苗（人二倍体细胞）
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