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First Avian Flu vaccine approved by FDA

Submitted by Sadaf Afzal on Wed, 04/18/2007 - 13:46. ::

On Tuesday US Food and Drug Administration (FDA) approved the first human vaccine against the H5N1 influenza virus. The vaccine will help to protect people against the flu pandemic, although the vaccine is still not for sale, instead the government has bought huge stocks to put into reserve and use when the need arises.

The vaccine’s been developed by Sanofi Pasteur, a division of the French company, Sanofi-Aventis and is reported to have certain drawbacks. According to the health officials, it would be useful against only a 45 percent of the population, despite being administered twice with a 28 days gap.

Bird Flu is caused by H5N1 strain of influenza, and is a major public health threat to the nation, as expressed by the FDA officials. There have not been any reported case of Avian Flu in the United States, but so far it has affected 291 people around the world and killed 172 out of them. These cases were mostly reported in Asia according to the World Health Organization’s data.

FDA's Norman Baylor, PhD, said in a news conference that "The threat of an influenza pandemic is one of the most important public health issues our nation faces today.”

The vaccine has been approved for use only in adults aged 18-64 who are at a greater risk of being affected by the bird flu virus. The patients will receive a 90 microgram of shot initially and then another 90 microgram after 28 days.

The most common side effects seen during a clinical study conducted on 103 healthy adults to check the effect of the vaccine on immune system were headache, pain at the injection site, general illness and muscular pain.

Health officials are more concerned of its slow response in case of the flu’s outbreak, however, it is being considered as an interim measure until more effective and fast reacting drugs are developed.

Despite its drawbacks, the vaccine is still considered to be a good start in the fight against the deadly disease. More effective vaccines are in the process of being developed.

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