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
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,
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
With such a tiny amount of needed antigen, Friedland said
Glaxo could easily make "far more doses" of the vaccine than it
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)
- Pharmaceuticals & Drug Trials