Chinese vaccinemaker Sinovac Biotech has won a grant from the Chinese government to build a production facility to manufacture its vaccine against hand, foot, and mouth disease (HFMD). The awarding of the grant is a good omen that the government will approve the company's vaccine, which was submitted last year for approval.
The ¥60 million ($9.6 million) "free government grant" will be used to build a dedicated facility for its enterovirus 71 (EV71) vaccine. The company will get ¥20 million up front and the balance when it meets the criteria of the grant, it said in an announcement today. Those criteria include the plant meeting China's GMP requirements, that it be capable of producing 20 million doses of EV71 vaccine, and that the company commercializes the vaccine in China.
"From 2007 to 2013, over 9 million cases of HFMD have been reported in China with approximately 2,700 reported fatalities," Sinovac CEO Weidong Yin said in a statement. "This epidemic situation represents a significant unmet medical need for the EV71 vaccine. With the government support for building out the dedicated production capacity, Sinovac is poised to provide the EV71 vaccine to help address this potentially fatal childhood disease for which no commercialized vaccine and no EV71 specific treatment exist."
While based in and focused on China, Sinovac is also approved to sell some of its vaccines in other countries, like Mexico. It is the only supplier of the H5N1 pandemic influenza vaccine to the Chinese government-stockpiling program. It submitted its EV71 application to the China Food and Drug Administration in May 2013, and the vaccine is currently under technological review by China's Center for Drug Evaluation.
- read the announcement