Thursday, May 30, 2013

Sinovac Biotech files NDA in China for EV71 vaccine intended for protection against Hand foot mouth disease

Sinovac Biotech Ltd has filed a  new drug application (NDA) for its proprietary EV71 vaccine. The application has been accepted by the Beijing Drug Administration.  In terms of next steps for the NDA review process in China, the Beijing Drug Administration will conduct an on-site inspection on the circumstances of Sinovac’s clinical trials and submit its on-site inspection opinion along with the application documentations to Centers for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) for further review and evaluation.

EV71 Clinical data

In March 2013, Sinovac completed the Phase III clinical trial which enrolled 10,000 healthy volunteers, ages from 6 to 35 months old.   Preliminary top line data showed that EV71 vaccine had 95% efficacy rate against Hand Foot Mouth Disease caused by enterovirus 71 (EV71). Throughout the three phases of the clinical trials, the results demonstrated a good safety, immunogenicity and efficacy profile for Sinovac’s proprietary EV71 vaccine candidate.  In China in 2012, 2.16 million cases of EV71 were reported along with 560 EV71 related fatalities in 2012. 

In parallel, 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 attentions to the vaccine development and aim at supplying the high-quality vaccines against EV71 to the high-risk populations as soon as possible. As you may remember, in late 2010, Sinovac was approved by CFDA to continuously conduct all three phases of the human clinical trials on EV71 vaccine candidates instead of phase by phase approval as the standard process.

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