The approval covers ages 9 to 26 and rests on a trial in men who reported sex with men, where Gardasil prevented HPV 16- and 18-related anal intraepithelial neoplasia in 78% of participants. The FDA assumed the same efficacy applies to women.
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Drug
Gardasil gets FDA okay to fight anal cancer
The FDA expanded Gardasil's approved use to prevent anal cancer and precancerous lesions caused by HPV types 6, 11, 16 and 18. The American Cancer Society estimates 5,300 anal cancer diagnoses a year in the US, and HPV is associated with about 90% of cases.
Drug
Cool Ads Aren't Helping Gardasil and Cervarix Vaccines
Research presented to the American Association for Cancer Research finds women declining the heavily advertised HPV vaccines, with a third not returning after the first of three shots. The piece questions the $359.25 price and cites 56 US girls' deaths reported to the CDC after vaccination.
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