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03/19/08

US Government Agrees to Consider Approving Gardasil Use by Women Up to Age 45


On Wednesday, Merck & Co. announced that the Food and Drug Administration is expected to decide by mid-year whether to expand use of the Gardasil vaccine to women ages 27-45. The vaccine, which blocks four types of human papillomavirus (HPV) linked to cervical cancer and genital warts, is currently approved for use in females ages nine to 26.

In its request to FDA, Merck noted that women remain at risk for HPV infection throughout their lives. The government estimates that more than 6 million people are newly infected with the STD every year.

Gardasil targets HPV types 6, 11, 16, and 18. The vaccine is preventive, as it does not cure existing HPV infection, experts say. Thus, it is recommended that females receive Gardasil prior to becoming sexually active.

Kelley Dougherty, a spokesperson for Merck, said an advisory committee will consider whether to recommend testing for HPV infection before getting the vaccine. But, she noted, commercially available HPV tests do not differentiate between types of the virus. Research has shown that few women are infected with all four types, so getting the vaccine would protect them from any of the four they had not contracted, she added.


Source: Associated Press; Courtesy of the CDC National Center for HIV, STD, and TB Prevention