Sanofi pasteur reported that FDA licensed the first avian influenza vaccine for humans in the U.S.
The licensure is an initial 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 during the early stages of a pandemic.
The deal is based on an NIAID clinical trial. It evaluated the safety and ability to generate an immune response of this vaccine when administered in two 90 µg/mL doses in healthy adults 18 through 64 years. 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, according to sanofi pasteur.