Asian Scientist (Feb. 11, 2014) – Sinovac Biotech Ltd., a provider of biopharmaceutical products in China, announced today that it has submitted a clinical trial application (CTA) with the China Food and Drug Administration(CFDA) to commence human clinical trials for its vaccine against Avian influenza A (H7N9) virus. The CTA was officially accepted by CFDA on January 29, 2014.
Incidence rates for H7N9 continue to increase in China, with 153 H7N9 Human infectious cases reported in 2013 according to the World Health Organization(WHO). In January 2014, 96 H7N9 cases were reported in China, including 20 fatalities.
Sinovac commenced development of its proprietary H7N9 vaccine at the beginning of 2013, when the continuous H7N9 infectious cases were reported in China. The H7N9 vaccine was developed using Sinovac’s existing flu vaccine development and production platform that includes its seasonal influenza vaccine, its pandemic influenza vaccine against H5N1 and its pandemic A(H1N1) vaccine.
Sinovac obtained the avian influenza A (H7N9) virus strain from the WHO in May 2013 and has subsequently completed pre-clinical research, preparing different types of vaccine candidates for clinical testing. Clinical trials are expected to start soon after the CTA is approved.
Sinovac is the only company in China that has approval to manufacture the H5N1 avian flu vaccine since and was also the first company globally to successfully develop and launch the H1N1 vaccine in 2009.
Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “ In line with our corporate mission to supply vaccines to eliminate human diseases, Sinovac had established a quick responding mechanism to provide vaccines to deal with the influenza pandemic, which has successfully applied to the development on H5N1 vaccine and H1N1 vaccine in the previous years.
“This time, the H7N9 vaccine was developed with the existing flu vaccine technology and production platform. The H7N9 vaccine will be produced in our existing flu facilities. We are well prepared to move forward with the clinical development to prove the safety and immunogenicity profile of the H7N9 vaccine candidates.”
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