By Ransdell Pierson
(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.
London-based drugmaker said the advisory panel of outside medical
experts voted 14 to 0 to support its vaccine against the H5N1 bird flu
The virus is spread among birds but sometimes infects people, with highly fatal consequences.
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.
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.
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.
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.