The FDA said on Tuesday that Sanofi-Aventis SA is very useful when the H5N1 strain of avian influenza mutates into a form that can spread easily among humans. According to estimates by the World Health Organization (WHO), at least 291 people worldwide have been infected with the virus since 2003, and 172 have died.
Though the vaccine is not ready for its commercial use, the U.S. government has already stockpiled millions of its doses for use in emergency. It is the first drug ever to win the FDA approval for treatment of H5N1 virus.
AP quotes FDA commissioner Dr. Andrew von Eschenbach as saying, "The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces. The approval of this vaccine is an important step forward in our protection against a pandemic."
The vaccine, which is given in two 90-microgram shots, about a month apart, raised a protective immune response in 45 percent of study participants. This is 70 percent short of the goal the FDA set last year for a pandemic vaccine.
