U.S. FDA approves GSK's bird flu vaccine for national stockpile

Fri Nov 22, 2013 6:14pm EST

Signage is pictured on the company headquarters of GlaxoSmithKline in west London July 21, 2008. REUTERS/Toby Melville

Signage is pictured on the company headquarters of GlaxoSmithKline in west London July 21, 2008.

Credit: Reuters/Toby Melville

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(Reuters) - The U.S. Food and Drug Administration said on Friday it has approved a vaccine made by GlaxoSmithKline Plc for use in the event of an H5N1 bird flu epidemic.

The vaccine, Pandemrix, will be added to the national stockpile and will not be available for commercial use, the FDA said.

It is the first H5N1 vaccine approved in the United States to contain an adjuvant, or booster, that turbo-charges the body's immune response to the vaccine.

"This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe," Dr. Karen Midthun, director of the FDA's biologics division, said in a statement.

The FDA approved the vaccine for use in people over the age of 18 who are at increased risk of exposure to the virus. It would be distributed by public health officials if needed.

The approval comes amid some uncertainty over the safety of modern adjuvants such as the one used in GSK's bird flu vaccine.

However, there are no effective traditional vaccines against bird flu. Glaxo's super-charged product is the first to show it can confer protection in the event of a pandemic. European regulators have approved it under the brand name Pumarix.

Data shows that children in England who received a similar adjuvanted vaccine during the 2009-10 H1N1 swine flu epidemic had a 14-fold heightened risk of developing narcolepsy, a chronic and potentially debilitating sleep disorder that can cause hallucinations, daytime sleepiness and cataplexy, a form of muscle weakness precipitated by strong emotion.

According to GSK, some 30 million doses of Pandemrix were administered across Europe and 800 people, mostly children, developed narcolepsy. While GSK has acknowledged an association between the vaccine and the narcolepsy cases, it has said there is insufficient evidence to prove the adjuvant was to blame.

Adjuvants have been used in vaccines for diseases such as diphtheria and tetanus for decades. Now, a new, more powerful generation of adjuvants, including one known as AS03 that is contained in the bird flu vaccine, is being developed whose safety is relatively untested.

Previously, the United States has taken a more cautious approach toward adjuvants than some other countries. The FDA did not, for example, approve Pandemrix for H1NI swine flu. U.S. experts felt that traditional, non-adjuvanted H1N1 vaccines made by Sanofi SA and others offered enough protection against the virus.

But an advisory panel voted unanimously that the FDA should approve the vaccine against bird flu, which kills nearly 60 percent of those who become infected. By comparison, the H1N1 virus kills fewer than 1 percent of those infected.

The H5N1 bird flu virus was first isolated in a human in Hong Kong in 1997 and began to spread throughout Southeast Asia in 2003. A 2011 report by the World Health Organization showed only 566 people had been infected with bird flu worldwide, compared with millions infected with the 2009 H1N1 swine flu virus. But the death rate for bird flu is far higher.

(Reporting by Toni Clarke; Editing by Leslie Adler)

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Comments (1)
bettysenior wrote:
We have been telling people in authority and governments now for nearly 6-years that the vaccine strategy to defeat bird flu and its transference to humans is sheer madness, as bird flu viruses are constantly mutating. Therefore the new so-called bird flu vaccine that was announced recently and stockpiled for the great and the good, is a useless exercise. Indeed the only way to stop this killer disease which Margaret Chan has said many times, is only a matter of time not when, is never to allow it to start in the first place. In this respect if we equate the numbers that died throughout the Spanish Flu of up to 100 million worldwide to the one that will eventually emerge, it is estimated that today between 500 million and 1 billion lives will be lost. Therefore we simply have to adopt the global strategy that the man who first discovered that the killer virus had jumped into humanity – http://www.thewif.org.uk/home/shortridge_thailand_2008.pdf

And to know the reasons why this strategy was suppressed by the giant pharmaceutical companies visit – http://foolscrow.wordpress.com/2010/07/27/return-to-nuremberg-big-pharma-must-answer-for-crimes-against-humanity/

Dr David Hill
Chief Executive
World Innovation Foundation

Nov 29, 2013 2:05pm EST  --  Report as abuse
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