GSK — GlaxoSmithKline H5N1 Bird Flu Vaccine Gets FDA Green Light

by Christopher Freeburn | November 25, 2013 9:28 am

vaccine GSK    GlaxoSmithKline H5N1 Bird Flu Vaccine Gets FDA Green Light[1]
Source: Flickr[2]
Federal regulators have given the green light to a vaccine meant to contain a global outbreak of bird flu[3].

However, consumers won’t be able to get the vaccine from GlaxoSmithKline (GSK[4]), which has been designed to prevent infection by the H5N1 version of bird flu. The Food and Drug Administration approved the vaccine on Friday, but said the vaccine will added to stores of bird flu drugs being stockpiled by the government in case of an epidemic. The vaccine, which does not have a brand name, will not be made commercially available in the U.S., Reuters notes.

The vaccine, which includes and adjuvant to increase its effectiveness, has been cleared for use in individuals who are 18 or older. It would only be deployed if bird flu became more easily spread by human contact, sparking a global pandemic. The GSK vaccine is reportedly the first treatment to demonstrate the ability to prevent bird flu infection.

In Europe, the vaccine — marketed as Pumarix — has also been cleared for use.

Earlier this year, physicians in Asia noted that a popular flu treatment was no longer effective on some bird flu patients[5].

Shares of GSK fell modestly in Monday pre-market trading.

Endnotes:
  1. [Image]: http://investorplace.com/wp-content/uploads/2013/01/vaccine.jpg
  2. Flickr: http://www.flickr.com/photos/danielpaquet/5115649509/sizes/l/in/photostream/
  3. vaccine meant to contain a global outbreak of bird flu: http://news.yahoo.com/fda-approves-gsks-bird-flu-vaccine-national-stockpile-151522672--finance.html
  4. GSK: http://studio-5.financialcontent.com/investplace/quote?Symbol=GSK
  5. was no longer effective on some bird flu patients: http://investorplace.com/2013/05/study-new-bird-flu-resistant-to-roches-tamiflu/#.UpNd9pG1Kf0

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