The FDA is announced the licensure of the first vaccine in the United States for humans against the H5N1 influenza virus, commonly referred to as avian influenza or "bird flu." This inactivated influenza virus vaccine is indicated for immunization of persons 18 through 64 years of age who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine. This vaccine is derived from the A/Vietnam/1203/2004 influenza virus. The vaccine is manufactured by Sanofi Pasteur Inc. of Swiftwater, PA and has been purchased by the federal government for inclusion within the Nation's National Stockpile.
Should such a bird flu pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced. "The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The approval of this vaccine is an important step forward in our protection against a pandemic."
