WRAPUP1-Glaxo’s Cervarix vaccine faces delays, concerns

Reuters

* FDA needs more time to weigh product

* No indication delay is linked to UK death

* Vaccine batch recalled following teenager’s death

* Cervarix gets support in Japan

By Susan Heavey

WASHINGTON, Sept 29 (Reuters) – GlaxoSmithKline Plc’s (GSK.L) (GSK.N) 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.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.