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Sinovac Receives SFDA Approval For Pandemic Influenza H5N1 Vaccine

Armen Hareyan's picture

Sinovac Biotech's pandemic influenza H5N1 whole viron inactivated vaccine has been granted a production license by the China State Food and Drug Administration (SFDA). Panflu is the first and only approved vaccine available in China against the H5N1 influenza virus. Per the production license for Panflu granted by SFDA, the vaccine is approved for production solely to be supplied to the Chinese national vaccine stockpiling program and will not be sold directly to the market. The license also indicates that the Chinese government has the exclusive right to initiate Panflu vaccinations in an emergency or in the event of an influenza pandemic.

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Mr. Weidong Yin, Chairman, President and CEO, stated, "The SFDA's approval of Panflu is an important milestone for Sinovac. Our clinical development team has devoted significant effort over the past four years and we are proud of this achievement. Sinovac is the only company in China that has successfully completed clinical trials for a pandemic influenza vaccine candidate, submitted the results to the SFDA, and received regulatory approval of production license. The government of China has indicated publicly their intention to stockpile the vaccine in advance of the Olympic Games in Beijing this summer. Sinovac is committed to working closely with the regulators and the government to develop and implement the national stockpiling program for the pandemic influenza vaccine."

Sinovac previously announced positive top-line results of a randomized, double-blind, Phase II clinical trial of its pandemic influenza (H5N1) vaccine at the end of 2007. The Phase II clinical trial results were submitted in February 2008 to the SFDA.

Sinovac commenced the development of a pandemic influenza vaccine in 2004. In June 2006, the Phase I clinical trial results indicated good immunogenicity and safety. In September 2006, the results were published in "The Lancet," an independent medical journal.