- The Washington Times - Tuesday, April 17, 2007

The Food and Drug Administration yesterday announced approval of the first vaccine to protect against the avian flu virus, commonly known as bird flu.

The vaccine, which has yet to be named, is manufactured by Sanofi-Aventis SA and is being viewed by public health officials as a deterrent to the virus rather than a panacea.

“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 FDA said.

Bird flu is known to have infected nearly 300 people in 12 countries since 2003, killing more than half of them and raising fears of a global pandemic. However, the virus has yet to strike birds or people in the United States. Despite avoidance of the virus in the United States, the approval of the vaccine is significant because of the scant immunity available.

Human cases of bird flu generally have been linked to contact with infected poultry, often causing multiple organ failure and pneumonia. Health experts fear the virus may mutate into a form that passes easily from human to human, causing a pandemic.

“The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces,” said FDA Commissioner Andrew C. von Eschenbach. “The approval of this vaccine is an important step forward in our protection against a pandemic.”

The vaccine will not be sold commercially; rather, the U.S. Strategic National Stockpile will buy the vaccine for distribution, if needed. The government’s stockpile of medicine, medical supplies and vaccines can be delivered to any state within 12 hours.

In clinical studies, the most common side effect of the vaccine was headache and muscle pain.

The FDA noted that the National Institutes of Health, other government agencies and pharmaceutical manufacturers are working to develop a next-generation vaccine that can be given at lower doses with better immune response than the Sanofi vaccine.

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