GlaxoSmithKline secures FDA approval for its pandemic vaccine

Posted Nov. 11, 2009 at 7:19 a.m.

GlaxoSmithKline secures FDA approval for its pandemic vaccine

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RESEARCH TRIANGLE PARK, N.C. – GlaxoSmithKline (NYSE: GSK) plans to begin deliveries of more than 7 million doses of a version of its H1N1 pandemic vaccine to the U.S. in December now that it has received approval from the U.S. Food and Drug Administration.

However, clinical testing continues for the adjuvanted, or boosted, version of the vaccine.

GSK said Tuesday that the FDA had approved its “supplemental biologics application,” clearing the way for production at its vaccine plant in Canada.

The U.S. government has already contracted with GSK for 7.6 million doses.

The unadjuvanted vaccine is for use in adults.

Testing of the adjuvanted – which is boosted by compounds designed to increase the response of the human immune system – is continuing in North America, Europe and Japan, GSK said.

Also on Tuesday, GSK said it had reached an agreement with the World Health Organization to donate 50 million does of the adjuvanted vaccine to developing countries. Shipments should begin before the end of the month, GSK said.

“GSK is committed to supporting governments and health authorities around the world in their efforts to protect their populations against this pandemic. Our commitment recognises the needs of developing countries, and this donation of 50 million doses will enable vaccination to begin soon in some of the world’s poorest countries.” said Andrew Witty, GlaxoSmithKline’s chief executive officer, in a statement.

WHO hailed the agreement.

"We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world's poorest people,” said WHO Director-General Margaret Chan. “This is a real gesture of global solidarity towards those who would not be otherwise able to have access to the vaccine.”

GSK maintains its U.S. headquarters in RTP and employs some 4,000 people in the area.