FDA approves first U.S. bird flu vaccine for humans

Washington, D.C. - 4/17/07 - The U.S. Food and Drug Administration announced approval of the nation's first human vaccine for H5N1 influenza, commonly known as avian or bird flu.

Obtained from a human strain and intended for immunizing 18- to 64-year-olds at risk for increased exposure to the virus, the vaccine consists of two intramuscular injections given one month apart.

The manufacturer, sanofi pasteur, Inc., refuses to sell the vaccine commercially, so the federal government purchased vaccines to be included with the U.S. Strategic National Stockpile for distribution by public health officials, if needed.

The vaccine can be used if the current H5N1 avian virus develops the ability to spread from human to human, causing an influenza pandemic. It may also provide early limited protection until a vaccine tailored to the pandemic strain is developed and administered.

"The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces," says Andrew C. von Eschenbach, M.D. and FDA commissioner. "The approval of this vaccine is an important step forward in our progression against a pandemic."

The H5N1 virus is one version of the influenza A virus commonly found in birds. While seasonal influenza infection ranges from mild to serious symptoms in most people, the disease caused by H5N1 is more severe and happens quickly, with pneumonia and multi-organ failure commonly seen.

While there have been no reported human cases of H5N1 infection in the US, almost 300 people worldwide have been infected since 2003 and more than half have died. H5N1 has remained primarily an animal disease, but if the virus acquires the ability for sustained transmission, a pandemic could arise because of humans' weak immunity to the strain.

"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," says Jesse L. Goodman, MD, MPH and director for the FDA's Center for Biologics Evaluation and Research. "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."