The licensure serves as a first key step in achieving the government’s goal of stockpiling vaccine intended to protect those who are at increased risk of exposure to the H5N1 influenza virus contained in the vaccine during the early stages of a pandemic.
“The licensure of the nation’s first vaccine is a significant milestone in pandemic preparedness,” said David Williams, president, chairman and CEO of sanofi pasteur.
The licensure of this vaccine was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases. The study, which was completed in 2005, showed that the vaccine elicited an immune response against the H5N1 virus and was associated with mild side effects.
Sanofi Pasteur has recently invested in a major expansion of its influenza vaccine production capacity in both the US and France.