FDA Delays Ruling on Glaxo Cervical Cancer Vaccine

From CNSNews:

Washington (AP) – The Food and Drug Administration has delayed a decision on GlaxoSmithKline’s vaccine for cervical cancer, according to the British drugmaker.

The FDA was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a Glaxo spokeswoman said the review will continue.

The announcement came one day after British health officials reported a 14-year-old girl died a few hours after receiving the vaccine.

Britain’s National Health Service began offering Cervarix to teenage girls last year, and more than 1.4 million doses of the vaccine have been given out under the program.

Glaxo spokeswoman Sarah Alspach said the death did not influence the FDA’s decision to extend its review.

“The FDA has not indicated the extended review is related to any safety concern,” Alspach said in a statement.

An FDA spokeswoman said the agency does not comment on pending product reviews.

Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group’s advice, though it usually does.

Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional data. The vaccine blocks the two main viruses that cause most cases of cervical cancer.

An approval from FDA would allow London-based Glaxo to compete against Merck’s blockbuster vaccine Gardasil, which has been on the market here since 2006.

The human papilloma virus, or HPV, infects about 6 million people in the U.S. each year, and is spread mainly through sexual contact. It usually causes no symptoms and goes away within two years, although rare cases can develop into warts and cancer in both men and women.

Last year, nearly 4,000 women died of cervical cancer in the U.S., fewer than 1 percent of all deaths from cancer.


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