The FDA has awarded pharmaceutical company sanofi pasteur a licence for a H5N1 avian influenza vaccine.
The US Food and Drug Administration (FDA) has licensed sanofi pasteur's H5N1 vaccine, an avian influenza vaccine for humans. The decision to award the license was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases.
The trial evaluated the safety of the vaccine and its ability to generate an immune response in healthy adults aged 18 to 64. The study, completed in 2005, showed that the vaccine elicited an immune response against the H5N1 virus and was associated with mild side effects.
"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 immunisation 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 US government and others, to prepare for this crisis."
According to sanofi pasteur, granting the license will help the US government create a vaccine stockpile for use in a bird flu outbreak. The company has expanded its influenza vaccine production capacity worldwide and has signed deals with a number of governments for the supply of flu and bird flu vaccines.