FDA approves bird flu vaccine as a national inventory

FDA approves bird flu vaccine as a national inventory

 The Food and Drug Administration says it has approved vaccines made ​​by GlaxoSmithKline Plc to use in dealing with the H5N1 bird flu epidemic .

According to the FDA , the vaccine will be added as a national inventory and will not be used for commercial purposes . This vaccine does not have a trade name in the United States .

This is the first H5N1 vaccine approved in the United States containing an adjuvant , or booster that trigger an immune response to the vaccine .

" This vaccine can be used in dealing with the H5N1 avian flu virus could develop the ability to spread from human to human , causing rapid spread of the disease throughout the world , " said Dr. Karen Midthun , director of FDA's division of biology , as reported by Aljazeera .

The FDA approved the vaccine for use in people over the age of 18 years at risk of the virus . The vaccine will be distributed by health officials if needed .

The approval comes amid uncertainty over the safety of the use of modern adjuvant in GSK bird flu vaccine .

However , there is no traditional vaccine really effective against bird flu . Glaxo product is the first product to demonstrate it can provide protection in the event of a pandemic . European regulators have approved the vaccine under the brand Pumarix .

The data show that children in the UK who receive the adjuvanted vaccine , Pandemrix , during 2009 - 2010 , shows the H1N1 swine flu outbreak has the risk 14 -fold higher develop narcolepsy , a chronic sleep disorder and potentially cause hallucinations , daytime sleepiness and cataplexy which is a form of muscle weakness triggered by strong emotions .

According to GSK , approximately 30 million doses of Pandemrix is given in Europe and 800 people, mostly children and the result makes the effects of narcolepsy . GSK has recognized the relationship between the vaccine and cases of narcolepsy and said there was insufficient evidence to prove the adjuvant can be blamed .
Adjuvants have been used in vaccines for diseases such as diphtheria and tetanus for decades . But now , a new generation of adjuvants are being developed , including one known as AS03 contained in bird flu vaccine .

Previously , the United States has taken a more cautious against adjuvant than some other countries . But the FDA does not , for example, by agreeing Pandemrix . U.S. health experts feel that the non - adjuvanted H1N1 vaccine made ​​by Sanofi SA has shown considerable protection against the virus .

But the advisory panel agreed that the FDA should approve bird flu vaccine that has killed nearly 60 percent of those infected . In comparison , the H1N1 virus kills less than 1 percent of those infected .

H5N1 avian influenza virus was first isolated in humans in Hong Kong in 1997 and began to spread across South East Asia in 2003 . A report in 2011 by the World Health Organization reported a total of 566 people have been infected with bird flu around the world . It was compared to the millions infected with the H1N1 swine flu virus in 2009 . However, bird flu death rate is much higher