China FDA approval for Sinovac's EV71
Chinese vaccine maker Sinovac Biotech (Nasdaq: SVA) today announced that the China Food and Drug Administration (CFDA) issued the new drug certificate and production license for its Enterovirus 71 ("EV71") vaccine.
The CFDA completed its Good Manufacturing Practices (GMP) inspection simultaneously with the site inspection of the EV71 vaccine production facility in October 2015, and will issue the GMP license after the new drug certificate and production license are issued. Sinovac expects to receive the GMP license in early 2016 and will start commercial production of EV71 vaccine immediately afterwards. The company expects to deliver the vaccine to the market within four to five months after commercial production begins.
Sinovac's EV71 vaccine production facility is located in Beijing with an expected production capacity of 20 million doses annually. This vaccine will target children aged six-35 months, with each child requiring a total of two doses one month apart from another.
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