BEIJING — Sinovac Biotech Ltd. announced Dec. 28 that it has applied to China's State Food and Drug Administration to begin a human clinical trial for its vaccine against the virus that causes hand, foot, and mouth disease (HFMD).
This is the first clinical trial application for HFMD vaccine submitted in China.
No vaccine or antiviral treatment is currently available for HFMD worldwide. The disease is highly contagious and a growing number of HFMD cases have been reported in parts of Asia, including China, Hong Kong, Singapore, Korea and Taiwan.
According to China's Center for Disease Control, between Jan. 1 and Nov. 30, the disease has caused more than 400 deaths in China, where health authorities reported more than 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths.
“A vaccine against EV 71 represents a significant unmet medical need, given that there are not effective preventive therapeutic alternatives for this life-threatening viral illness affecting infants and children,” said Weidong Yin, chairman, president and CEO of Sinovac.
Enterovirus 71, or EV 71, causes hand, foot, and mouth disease. More than 90 percent of the reported cases occur in children younger than 5 years old. HFMD is a common and usually mild childhood disease. Many 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 and 2001), China (1998-2008), Australia (1999) and Singapore (2000) among other areas.
In 2008, 489,073 cases were reported in China with 126 reported fatalities. For the first 11 months of 2009, more than 1.1 million cases were reported in China, with more than 400 reported fatalities.