FDA advisory panel backs prototype Glaxo bird flu virus

Wed Nov 14, 2012 5:44pm EST

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Nov 14 (Reuters) - An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously that a GlaxoSmithKline Plc prototype vaccine against bird flu appears to be safe and produces the desired immune-system response against the highly fatal virus.

The London-based drugmaker said the advisory panel of outside medical experts voted 14 to 0 to support its vaccine against the H5N1 bird flu virus.

The virus is spread among birds but sometimes infects people, with highly fatal consequences.

"Glaxo looks forward to the approval by the FDA of our vaccine, hopefully later this year," said Leonard Friedland, a senior U.S. vaccine executive for the London-based drugmaker.

Friedland told Reuters there have been 608 cases of bird flu around the world since 2003, with 359 deaths.

If approved by the agency, Glaxo would be licensed to make millions of doses of the vaccine, which would likely be placed in a government stockpile for use in the event of a global epidemic.

The company would also be prepared to make as many other doses as required, perhaps including a slightly different strain of the virus than the Indonesia strain in its current prototype, Friedland said.

Glaxo contracted with the federal government in 2007 to make a prototype vaccine to protect against potential infection with the bird flu. It contains only 3.75 micrograms of the inactivated H5N1 antigen, or protein, compared with 90 micrograms in an already licensed vaccine made by French drugmaker Sanofi.

With such a tiny amount of needed antigen, Friedland said Glaxo could easily make "far more doses" of the vaccine than it otherwise could.

A special adjuvant boosts the effectiveness of the Glaxo vaccine, Friedland said, allowing for less antigen.

"It's the adjuvant that makes the difference," he said.

(Reporting by Ransdell Pierson; Editing by Dan Grebler)

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