The FDA has approved the first vaccine in the U.S. for humans against the H5N1 influenza virus, commonly known as avian flu or bird flu.
The vaccine, made by Sanofi-Pasteur, could be used if the current H5N1 avian virus were to develop the capability to spread among humans. If such an influenza pandemic emerges, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be produced.
The H5N1 virus is one version of the influenza A virus commonly found in birds. Unlike seasonal influenza, the disease caused by H5N1 is more severe and occurs quickly. Pneumonia and multi-organ failure are commonly seen.
Almost 300 people worldwide have been infected with this virus since 2003; more than half of them have died.
The vaccine, obtained from a human strain, is intended for people 18 through 64 years of age. Two intramuscular injections are given approximately one month apart.
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Sanofi-Pasteur does not plan to sell the vaccine commercially. The federal government has purchased it to be included within the U.S. Strategic National Stockpile for distribution by public health officials if needed.
In a study, 45% of people who received the 90-mcg, two-dose regimen developed antibodies at a level expected to reduce the risk of influenza.