Glaxo's Cervarix vaccine faces delays, concerns

By Susan Heavey

WASHINGTON (Reuters) - GlaxoSmithKline Plc's bid to sell its Cervarix cervical cancer vaccine in the United States faced further delay on Tuesday and the company recalled a batch of the vaccine in Britain following a teenager's death.

The U.S. Food and Drug Administration again postponed a decision on the British drugmaker's application, saying it needed more time to review the product. It was the second deferral by the agency since Glaxo sought approval in 2007.

The delay comes one day after news that a 14-year-old girl in Britain died shortly after receiving the shot, but Glaxo said there was no link between the FDA delay and 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 one official said a link between the death and the vaccine was unlikely. Glaxo said on Tuesday it was voluntarily recalling the batch of the vaccine that was used pending any findings.

FDA spokeswoman Shelly Burgess confirmed the agency had not approved Cervarix but had no comment on the death.

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

But some analysts no longer see much chance for Glaxo's product to become the blockbuster, as once hoped, given Merck's three-year lead in the U.S. market.