FDA approves Gardasil as a vaccine against anal cancer

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The FDA announced yesterday that it has approved Gardasil, Merck’s vaccine against four common strains of human papillomavirus (HPV), for the prevention of anal cancer. Gardasil was already approved as a vaccine to prevent cervical, vulvar and vaginal cancers and genital warts.

The FDA decision follows on a randomized study of 4,065 patients given the vaccine. Included in the research were 602 men who have sex with men. This latter sub-population is at significantly increased risk for anal cancer. The researchers demonstrated that the vaccine has a high rate of efficacy in preventing the transmission of HPV strains 6, 11, 16 and 18. These HPV types have been shown to be the leading causes of cervical and anal cancer.

ACSH’s Dr. Gilbert Ross notes that Gardasil will almost certainly in time be approved as a vaccine against oral and pharyngeal cancers, too. He points out as well that a regimen of the vaccine — which typically involves three shots — provides important protection against all these forms of cancer.

“The arguments against widespread inoculation with the vaccine come from three camps,” Dr. Ross comments. “Some object to the expense. Others are anti-vaccine hysterics. A third group of opponents think that injecting kids with the vaccine will encourage them to be sexually promiscuous. There is, of course, no evidence for that, and the vaccine poses no danger.”

He goes on to say: “The vaccine does cost about $300 or more per patient, which isn’t cheap. But it can save lives. Cervical cancer alone kills over 4,000 women each year in the U.S., and many more globally. So, while we don’t know how long the vaccine protection will last, those between the ages of 9 to 26 should get vaccinated.”