Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).
EV71 Clinical Trial
The double-blinded, randomized, placebo controlled Phase III trial is being conducted at three sites across China's Jiangsu province. This study is designed to demonstrate the efficacy of the EV71 vaccine in the prevention of the diseases caused by EV71 in infants 6 to 35 months old. About 10,000 healthy infants completed the vaccination schedule in the first quarter of 2012, prior to the epidemic season for HFMD in China. The disease surveillance period began 28 days after completion of the two-dose regimen.
A three arm active surveillance system, comprised of village health clinics, township hospitals, and local county Centers for Disease Control and Prevention (CDC), has been established at each clinical site and is in charge of epidemic surveillance, case diagnosis, epidemiological survey, and sample collection.
When a case is identified by village or township doctors, throat swabs and anal swabs are collected from the patient. Physicians from the CDC then make visits to examine the child, record information and collect additional specimens for further tests. All samples are immediately sent to the laboratories for virus identification. A part of blinded samples are sent to the national CDC laboratory for confirming the previous testing results. According to the trial protocol, the Data and Safety Monitoring Board (DSMB) will review the clinical and laboratory results and confirm the diagnosis of EV71-associated disease before unblinding.
A number of patients with HFMD symptoms have been identified EV71 positive. All professionals in the surveillance system are actively monitoring the epidemic situation to try to achieve the clinical target in advance.
EV71 Commercialization Preparation
Sinovac has completed construction of the dedicated EV71 vaccine manufacturing facility at its Changping site north of Beijing, China, and finished installing its equipment. The Company is currently conducting its internal qualification and validation of the manufacturing equipment and production processes at the production plant. According to the Chinese regulation, before submitting a GMP inspection application, a manufacturer shall complete clinical studies and submit the clinical study report to SFDA. Once the result of clinical study is confirmed by SFDA experts, SFDA will issue the production license, which is a pre-requisite for GMP inspection application. By obtaining GMP certificate, the real commercial production can be commenced. Our objective with doing human trials and preparing facilities in parallel is to shorten the time for entire regulatory approval process for the EV71 vaccine.
"The current HFMD epidemic situation is one of the most serious in the past five years, with a nearly 110% increase in reported cases between January 2012 and May 2012, and with almost twice the number of fatalities," said Dr. Weidong Yin, Chairman and CEO. "There are no specific treatments for EV71 and no effective prevention methods, and we are continually reminded of the importance of rapidly developing a high quality vaccine against EV71. By simultaneously conducting the EV71 vaccine Phase III trial, maintaining ongoing discussions with the SFDA, and preparing our dedicated production facility, we intend to address this unmet need by being well positioned to provide this vaccine to our children soon after the vaccine is approved. We are on track to complete Phase III of the trial before the middle of next year."
SOURCE Sinovac Biotech Ltd.