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FDA Approves First Bird Flu Vaccine

April 17, 2007--Sanofi Pasteur’s vaccine to protect humans against the H5N1 influenza virus (bird flu) has become the first to receive U.S. FDA approval.

Of the nearly 300 people worldwide who have been infected with the H5N1 virus since 2003, more than half have died. There have been no reported human cases of H5N1 infection in the United States.

If the current H5N1 strain mutates to become easily transmissible among humans and triggers a pandemic, Sanofi Pasteur’s vaccine may provide early limited protection until the development of more effective vaccines.

In a news release from the FDA, Andrew C. von Eschenbach, Commissioner of Food and Drugs, cited the approval of this vaccine as an important step forward in protection against an influenza pandemic.

Sanofi Pasteur will not sell the vaccine commercially. It has been purchased for inclusion within the U.S. Strategic National Stockpile for distribution by public health officials if necessary.

 

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