FDA Rejects Gardasil for Older Women

John Gever
MedPage Today
April 7, 2011

The FDA has declined to expand the approved age range for the human papillomavirus (HPV) vaccine Gardasil to 45, according to the product’s manufacturer.

In the agency’s judgment, clinical trial data failed to show that Gardasil effectively prevented infections in women 27 to 45 years old, Merck said in a press release.

On the basis of the data Merck submitted, the vaccine’s label will now state that the product “has not been demonstrated to prevent HPV-related cervical intraepithelial neoplasia 2/3 or worse in women older than 26 years of age,” according to the company.

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This article was posted: Thursday, April 7, 2011 at 3:00 pm

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