A vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD), by Sinovac Biotech, will soon undergo human clinical studies in China.
Sinovac Biotech Ltd has filed the application with China’s State Food and Drug Administration (SFDA), the company announced in a press statement.
This is the first clinical trial application for human enterovirus 71 (EV 71) HFMD vaccine submitted in China.
No vaccine or antiviral treatment is currently available for HFMD worldwide, though it has become a very serious problem in Asia in recent years.
The disease is highly contagious and a growing number of HFMD cases have been reported in parts of Asia, including Mainland China, Hong Kong, Singapore, Korea, and Taiwan.
According to China’s Center for Disease Control (CDC) between January 1 and November 30 of this year, HFMD disease has caused more than 400 deaths in China, where health authorities reported over 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths.
HFMD is common among infants and children, as most of the recently reported cases have occurred in children.
Due to the severity of the disease epidemic, China authorities recognize the unmet medical need and are expected to support the launch of a HFMD vaccine as soon as possible.
Therefore, Sinovac believes that fast track status for the reviewing process and approval may be granted.
Sinovac began preclinical development in 2008. Sinovac is independently developing the EV 71 vaccine and will retain full commercialization rights of the vaccine upon approval.
Created by Sydney University, the animal model showed cross protection and demonstrated that the vaccine is effective in animals. In addition, Sinovac is preparing to file a patent application covering the EV 71 vaccine.
“Based on current expectations, we anticipate that the EV 71 vaccine, subject to positive human clinical trial results and commercialization, represents a significant flagship product opportunity for the company as well as an opportunity to improve the lives of children around the world,” stated Weidong Yin, chairman, president & CEO.
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.
EV 71 is a frequent cause of HFMD epidemics associated with neurological disease in a small proportion of cases.
A number of outbreaks of EV 71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), Mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. There is no specific treatment for enterovirus infections and a vaccine is not currently available.
In 2008, 489,073 cases were reported in China with 126 reported fatalities. For the first 11 months of 2009, over 1.1 million cases were reported in China, with over 400 reported fatalities.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases.
Sinovac’s vaccine products include Healive (hepatitis A), Bilive (combined hepatitis A and B), and Anflu (influenza). Panflu and Panflu.1, Sinovac’s pandemic influenza vaccine (H5N1) and H1N1 vaccine, have already been approved for government stockpiling.
Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccine.