FDA approve Sanofi's H5N1 vacc, first product for US emergency stockpile

The US Food and Drug Administration has approved an avian influenza vaccine made by leading French drugmaker Sanofi-Aventis, which is the government's first step in stockpiling enough vaccine to protect those who are at increased risk of exposure to the H5N1 influenza virus in the early stages of a pandemic. Sanofi Pasteur, the vaccines division of the drug major, said the approval was based on a clinical trial that evaluated the product's safety and immune reactivity when administered in two 90mcg/ml doses in healthy adults 18 through 64 years, which showed that it elicited an immune response against the H5N1 virus and was associated with mild side effects.