Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, has initiated the phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD). The phase II trial, completed in November 2011, confirmed favourable safety and tolerance profiles, and good immunogenicity.

According to the results of phase II clinical trial, the formulation of 400U with aluminum adjuvant was selected to be used in phase III clinical trial to evaluate the efficacy of Sinovac's EV71 vaccine in protecting against HFMD. The Phase III clinical trial is expected to enroll up to 10,000 healthy volunteers with ages 6-35 months, and was designed as a randomization, double blinded, placebo controlled study. The vaccination schedule calls for two shots at 0 and 28 days. Sinovac anticipates the trial to be completed in the first half of 2013.

Dr Weidong Yin, chairman, president and CEO, stated, “Commencing the phase III EV71 vaccine trial is a significant milestone. The enrollment was completed. And inoculation was initiated late last week and is going on well. The first shot to 10,000 volunteers is anticipated to be completed within one month. The advancement of the clinical program demonstrates our integrated clinical team's ability, as seen with our positive results from the Phase I and II clinical trials. The EV71 vaccine addresses a significant unmet medical need with over 5.14 million HFMD infection cases documented in China since 2007 with over 1900 fatal cases.”

Dr Yin continued, “In parallel to the clinical development, Sinovac's engineering team is building a dedicated manufacturing facility for the EV71 vaccine. We aim to complete the construction and to obtain a GMP certificate in 2013.”

Enterovirus 71, or EV 71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. However, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV 71.

In China, HFMD has become a very serious problem, especially in children, given that no vaccine and specific treatment is currently available to protect against this disease. A growing number of HFMD cases have been recently reported in parts of Asia, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan.

Sinovac Biotech Ltd. focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza.