Sinovac Biotech announced that the new drug application (NDA) for its ED71 vaccine has been filed and accepted by the Beijing Drug Administration. The Beijing Drug Administration will now conduct an on-side inspection of Sinovac's clinical trials and submit their opinion to the Centers for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) for further review and evaluation.
In April 2013, Sinovac presented Phase III top-line results at the World Vaccine Congress & Expo (press release). The data showed an approximate 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (EV71). The vaccine "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," said Dr. Weidong Yin, Chairman, President and CEO, Sinovac.
Sinovac also report that their dedicated EV71 vaccine manufacturing facility has been completed and is ready for GMP inspection by the CFDA.
The news comes a week after trial data published in The Lancet shows a new inactivated alum-adjuvant EV71 vaccine, made by Beijing Vigoo Biological, offered 90% protection against the virus. Read more: New vaccine developed for Hand, Foot and Mouth Disease in China.
If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Asia 2013, 17-20 June 2013, Singapore. There will be a presentation on âHand, Foot, and Mouth Disease: Overcoming challenges of conducting clinical studies for HFMD vaccine' from Shanshan Samantha Dong, Sinovac Biotech.