FDA advisory panel backs prototype Glaxo bird flu virus

Reuters Middle East

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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