FDA Approves First Avian Bird Flu Vaccine for Humans

The FDA approved the first vaccine for the H5N1 virus commonly known as the avian bird flu. This vaccine will not be available for general vaccinations but stock piled in the event that a strain of the virus breaks out that can easily spread from human to human. This vaccine would only provide a limited protection against this type of out break, but it is thought to be enough to prevent severe cases until a more tailored vaccine could be made and produced.

The H5N1 strain of influenza A is not like your common seasonal flu , that you can currently get vaccinations against. Though the seasonal flu can cause severe symptoms in some people usually those with immune issues. The avian strain can cause severe symptoms in all who contract it and commonly causes pneumonia and multi-organ failure.

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

Though the United States has not had a single case of this deadly virus there has been a reported 300 cases world wide with over half of the cases resulting in death. Should the virus mutate and become easily transmitted from human to human, we would have very little immunity to such a dangerous virus.

"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real." "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," said Jesse L. Goodman, M.D., M.P.H., Director of FDA's Center for Biologics Evaluation and Research.

The vaccine was obtained from the human strain of H5N1 virus and is designed for people 18 to 64 that would be a greater risk of exposer. It would given as two intramuscular shots given a month apart. The study showed little side effects with those most prominent being pain at injection site and headaches. Some also experienced a general ill feeling and muscle pain.

The vaccine is manufactured by, Sanofi Pasteur Inc., and will not be available for commercial distribution. It will be purchased by the United states for inclusion into the U.S. Strategic National Stockpile for distribution in the case of an outbreak here in the U.S. It will be made in the Sanofi Pasteur's Swiftwater, PA's facility. The vaccine will be available within twelve hours to any state in the event of an out break.

For more information on the Avian Flu Vaccine go the the FDA's Website at, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01611.html

(http://www.fda.gov/bbs/topics/NEWS/2007/NEW01611.html)