Sinovac Biotech (NSDQ: SVA) has applied to the SFDA to begin a clinical trial for a vaccine that protects against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). Sinovac began work on the vaccine over one year ago with research help from the CDC of China. At that time, Sinovac said enterovirus infections did not have specific treatments or a preventative vaccine. The company’s clinical trial application for a HFMD vaccine is the first filed in China.
HFMD, though usually mild, is highly contagious, affects mainly infants and children, and seems to always be present at a fairly low level until an outbreak occurs. In a small number of severe cases, it causes neurological damage. Incidence of the disease is currently on the rise in China. China’s CDC reports 1.1 million infections between January 1 and November 30 of 2009 and over 400 deaths. That is more than twice as severe as 2008, when 500,000 cases and 126 fatalities were reported.
To give 2009’s HFMD numbers further perspective, Sinovac adds that H1N1 flu, the current public health concern uppermost in most people’s minds, has caused 200 deaths so far this year.
Because of the public health risk, Sinovac expects China’s health establishment to embrace the vaccine, once approved, and to support its launch. The company hopes to receive fast track status for the reviewing process and approval.
Sinovac retains full commercialization rights of the EV 71 vaccine and will file a patent application protecting its IP.
Sinovac has been busy over the past few years extending its hepatitis B vaccine franchise into other vaccines. It developed vaccines for both seasonal and epidemic flu, which have enjoyed great sales success this year for the first time. In addition to its EV 71 vaccine, the company is working on an inactivated animal rabies vaccine, currently in field trials, universal pandemic influenza, Japanese encephalitis, and human rabies vaccines.