Transcript 疫情防治會報

Development of Enterovirus 71 Vaccine
in China
1. A phase III trial was conducted in 2012 and the results
were published in N Engl. J. Med 2014;370 : 818-828.
 Vaccine : The Vero cell-based inactivated human EV71
vaccine(Sinovac Biotech) contained 400U of EV71 antigen
with alum adjuvant was packaged in syringes (0.5ml per vial).
 Recipients : 10,007 Healthy infants and young children,6 to
35months of age, were vaccinated intramuscularly in the
deltoid region on day0 and day28.
 Surveillance : The effect of EV71 vaccine was evaluated
during a 12-month surveillance period from day 57 to month
14.
 Results : The vaccine efficacy against EV-71 associated HFM
disease was 94.8%. The vaccine efficacy against EV-71 associated
hospitalization and neurologic complications were both 100%.
 Conclusion : The EV-71 vaccine provided protection against EV71 associated HFM disease in infants and young children.
2. Future
 Vaccine manufacturer Sinovac has been awarded a US$9.6
million grant for the construction of a hand, foot and mouth
disease vaccine facility.
 Sinovac filed a new drug application (NDA) for its proprietary
EV71 vaccine. The NDA is currently under review by Centers for
Drug Evaluation.