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Home HPV Vaccines HPV Vaccines HPV Vaccine Not Approved for Older Women

HPV Vaccine Not Approved for Older Women

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In April the Food and Drug Administration (FDA) declined the application of Merck & Co. to approve Gardasil® for use with women ages 27-45. FDA said clinical trial data did not demonstrate the vaccine’s efficacy in preventing high-grade cervical precancers and cancers in women over the age of 26.

Gardasil® is currently approved for use with males and females ages 9-26 for the prevention of genital warts and anal cancers. The vaccine – along with GSK’s Cervarix® – can also be used with girls and young women for the prevention of cervical, vulvar, and vaginal cancers.

The FDA’s decision comes three years after the agency granted a priority review to Merck’s request to include older women in Gardasil’s® indication. The company based that application on clinical trials data that covered vaccine effectiveness through 24 months of follow-up.

In late June of 2008, however, FDA notified Merck that questions about the new indication couldn’t be resolved in the time allotted for the review and a decision would have to be tabled until later. In January 2009, Merck announced the FDA sent a second response letter asking for 48-month data.