Sinovac files new drug application for HFMD vaccine
The application was accepted by the Beijing Drug Administration, which will conduct an on-site inspection related to Sinovac's clinical trials. The agency will then submit an opinion along with application documentation to the China Food and Drug Administration's Centers for Drug Evaluation for further evaluation.
"Filing the NDA and receiving filing acceptance from the Beijing Drug Administration is a significant milestone as for the China regulatory process for our EV71 vaccine candidate," Weidong Yin, the chairman, president and CEO of Sinovac, said. "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."
In March, Sinovac completed a Phase III clinical trial for its EV71 vaccine candidate. The trial demonstrated approximately 95 percent efficacy rate for the vaccine against HFMD caused by E71. The three phases of the clinical trials demonstrated a good efficacy, safety and immunogenicity profile for the vaccine.
"(EV71 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," Yin said.
In 2012, China experienced 2.16 million cases of EV71 and 560 E71-related fatalities.