FDA panel backs new vaccine to prevent cervical cancer, plus Gardasil for boys


Update [Oct. 16]: Cervarix for girls, Gardasil for boys gets FDA approval.

For the past three years, Merck's vaccine Gardasil has been the lone option for cervical cancer prevention in the U.S. (check out our coverage of the 2006 approval). But today, an advisory panel told the Food and Drug Administration that a second vaccine called Cervarix merits approval in females ages 10 to 25 (Cervarix is already approved in Europe).

It's been a couple years since the FDA told GlaxoSmithKline, the maker of Cervarix, that the agency needed more data on the vaccine before it could be considered for approval. Then last week, the agency said Glaxo recently submitted data showing the vaccine was safe and effective against two strains of HPV, or human papillomavirus, that cause most cervical cancers.

Unlike Gardasil, however, Cervarix doesn't protect against two other types of HPV that cause genital warts. But the delivery of both is the same--a series of three shots over six months. The FDA, which typically follows the advice of the panel, could make a decision as early as the end of this month.Boys may also soon join the mix.

After backing Cervarix for approval, the panel shifted its focus to Gardasil and voted to recommend expanded use of Gardasil to males ages 9 to 26 for prevention of genital warts. Giving the vaccine to boys could also avoid the spread of HPV to female sexual partners and prevent penile and anal cancers in men, although Merck isn't seeking approval for those indications.

Not sure if you, your daughter, or your granddaughter should get vaccinated? The vaccine is most effective when given before sexual activity, so here's what the American Cancer Society currently recommends for each age group:> girls ages 11 to 12: The vaccine should be given to girls ages 11 to 12 and as early as age 9.> girls ages 13 to 18: Girls ages 13 to 18 who have not yet started the vaccine series or who have started but have not completed the series should be vaccinated. > young women ages 19 to 26: Some authorities recommend vaccination of women ages 19 to 26, but the American Cancer Society experts believed that there was not enough evidence of the benefit to recommend vaccinating all women in this age group.

We do recommend that women ages 19 to 26 talk to their doctors or nurses about whether to get the vaccine based on their risk of previous HPV exposure and potential benefit from the vaccine.There's a number of cancer organizations to turn to for more on cervical cancer and HPV. One group we've highlighted in CURE is Tamika & Friends, which offers education, support, and community. You can also check out the Gynecologic Cancer Foundation's cervical cancer site.

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