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FDA Delays Decision on Gardasil Vaccine Approval for Older Women

2009-01-12 12:04

The U.S. Food and Drug Administration has asked drug maker Merck & Co. for more information before it decides whether to expand approval for Gardasil, a human papillomavirus vaccine, Merck said Friday.

Gardasil is currently approved for females ages 9 to 26. Merck has asked the FDA to widen approval for its use in women aged 27 to 45, the Associated Press reported. The drug is designed to guard against HPV, which is responsible for most cases of cervical cancer.

The FDA wants additional data from an ongoing 48-month study of Gardasil, the wire service said. The agency's action does not affect currently approved uses or Merck's application to approve the drug for use in males ages 9 to 26.

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The vaccine costs about $360 for the three required doses, and some experts have said it's not cost-effective for older women, Dow Jones news service reported. A Harvard study funded by the U.S. government and published last year, found the vaccine was cost-effective for girls, but not for females in their 20s, the AP said.

It was last year that complaints caused Gardasil Cervical Cancer Vaccine scrutiny.

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