Sinovac Starts Phase II Trial of Pandemic Flu Vaccine

Sinovac Biotech Ltd. (AMEX: SVA) will begin enrolling volunteers in a Phase II clinical trial of its split viron pandemic influenza vaccine. The whole viron version of the vaccine has already completed its Phase II tests. The split viron candidate is being examined because it has the potential for a lower side-effect profile, and the test is, as a result, being conducted among adolescents and children. Preliminary results from the test are expected in early 2009.

The randomized, double-blind trial will enroll 210 adolescents between the ages of 12 to 17. They will receive doses of 10ug, 15ug or 30ug. Another 140 children, between the ages of 3 to 11, will receive doses of 10ug or 15ug. The test will collect safety and immunogenicity data from the volunteers, who will be followed for two months.

In December 2007, Sinovac reported positive top-line results from the Phase II clinical trial of Panflu, its pandemic influenza (H5N1) whole viron inactivated vaccine. In April 2008, Panflu received a production license from the SFDA for the vaccine. Panflu remains the first and only approved vaccine available in China that is indicated to protect individuals from the H5N1 influenza virus.

Disclosure: none.