UPDATE 1-Glaxo's Cervarix vaccine faces more U.S. delays

Tue Sep 29, 2009 12:24pm EDT

* FDA needs more time to weigh product

* No indication delay is linked to safety concern

WASHINGTON, Sept 29 (Reuters) - The U.S. Food and Drug Administration on Tuesday again shelved GlaxoSmithKline Plc's (GSK.L)(GSK.N) bid to sell its cervical cancer vaccine, saying it needs more time to review the product.

The delay comes one day after news a British teenager died shortly after receiving the shot, but Glaxo said there was no link between that case.

"The FDA has not indicated that the extended review in the U.S. is related to that event or to any safety concern," Glaxo spokeswoman Sarah Alspach told Reuters.

British health officials are investigating the girl's case, but have said a link between the death and the vaccine was unlikely.

If approved, Cervarix would rival Merck & Co Inc's (MRK.N) Gardasil. Both vaccines protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

Merck's product won FDA clearance in 2006, but the launch of Cervarix has been stalled since the FDA asked for more information following Glaxo's 2007 bid for approval. (Reporting by Susan Heavey; editing by Andre Grenon)

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