Sinovac Biotech’s NDA for its proprietary EV71 vaccine has been accepted by the Beijing Drug Administration, which will conduct an on-site inspection of Sinovac's clinical trials and submit its opinion along with the application documentations to the Centers for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA) for further review and evaluation.
In March, Sinovac completed the phase III clinical trial for EV71 and reported preliminary top-line data showing approximately 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (EV71). Throughout clinical trials, results have demonstrated a good safety, immunogenicity and efficacy profile for EV71. In 2012, 2.16 million cases of EV71 were reported in China, along with 560 EV71-related fatalities.
Sinovac's dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by CFDA.
“Due to the severe epidemic situation among children and infants in China, China Food and Drug Administration has been paying high attention to the vaccine development and supplying the high-quality vaccines against EV71 to the high-risk populations as soon as possible,” said Dr. Weidong Yin, chairman, president and CEO.
“In late 2010, Sinovac was approved by CFDA to continuously conduct all three phases of the human clinical trials on EV71 instead of phase-by-phase approval, the standard process,” said Yin. “And according to the results from the phase III clinical trial, our vaccine candidate demonstrated approximately 95% efficacy against HFMD caused by EV71 among the 10,000 healthy volunteers, ages 6 to 35 months, and has the potential to address a significant unmet medical need facing the pediatric population in China and surrounding countries given the high fatality rates and rapid onset of this highly contagious disease."