The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achieving the government's goal of stockpiling vaccine to protect those who are at increased risk of exposure to the H5N1 flu 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 chief executive officer of Sanofi Pasteur. "As the leading manufacturer of influenza vaccine in the world and a longstanding, responsible member of the immunization community, we will play a key role in helping safeguard human health if an influenza pandemic strikes. We look forward to continuing to work with the U.S. government and others, to prepare for this crisis."
The licensure was based on a successful trial conducted by the National Institute of Allergy and Infectious Diseases evaluating the safety and ability to generate an immune response when administered in two doses in healthy adults 18 through 64 years.