Date of Approval: April 17, 2007
Company: Sanofi Pasteur Inc.
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)
The U.S. Food and Drug Administration (FDA) has licensed Influenza Virus Vaccine, H5N1, the first avian influenza vaccine for humans in the U.S.
Sanofi pasteur, in collaboration with the National Institutes of Health, submitted a Biologics License Application to the FDA for this H5N1 vaccine. 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 this vaccine was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases. This trial evaluated the safety and ability to generate an immune response of this vaccine when administered in two 90
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