F.D.A. approves human H5N1 vaccine

by FoodBusinessNews.net Staff
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WASHINGTON — The Food and Drug Administration has approved a human vaccine for the HFN1 influenza virus — the virus more commonly known as avian or bird flu.

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

The H5N1 virus is one version of the influenza A virus, which is most commonly found in birds. The vaccine was developed from a human strain of the virus and may immunize those 18 to 64 years old who are at risk of being exposed to the H5N1 virus contained in the vaccine. The vaccination requires two shots given about a month apart.

The vaccine would be especially useful in the event the current H5N1 virus began spreading from human to human, causing a pandemic. The vaccine may provide early limited protection before a vaccine designed for the pandemic strain could be developed and produced.

The vaccine will not be sold commercially. The federal government has bought the vaccine to include in the U.S. strategic national stockpile for public health officials to distribute as needed. The vaccine is manufactured by sanofi pasteur, Inc. in Swiftwater, Pa.

"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," said Dr. Jesse L. Goodman, director of the F.D.A.’s center for biologics evaluation and research. "We are working closely with other governmental 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."

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