The U.S. Food and Drug Administration (FDA) announced December 22 that it has approved the first vaccine to prevent anal cancer for males and females ages 9 to 26. The vaccine, called Gardasil, was already approved to prevent genital warts and cervical cancer in girls and young women as well as genital warts in boys and young men.
Gardasil is a vaccine that targets four strains, or types, of human papillomavirus (HPV): Types 6 and 11, known to causes genital warts, and types 16 and 18, known to cause cervical and anal cancer. It was first approved in 2006 to prevent both genital warts and cervical cancer in girls and women ages 9 to 26, and later approved in 2009 to prevent genital warts in boys and young men, which it does quite effectively. Until now, however, the drug has not been approved to prevent anal cancer.
Though anal cancer is relatively rare in the general population, rates are far higher in men who have sex with men (MSM), and it’s nearly 60 times more common in HIV-positive MSM. For this reason, providers who treat people with HIV have been eager to see the vaccine approved for this purpose.
“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research in Rockville, Maryland.
When Gardasil was first approved in 2009 to prevent genital warts in males, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices declined to recommend vaccination for all boys and young men, as it had for girls and young women. Activists have been hoping that FDA approval for anal cancer prevention will convince the CDC panel to make this recommendation and therefore lead public and private health insurance to cover Gardasil’s cost in boys and young men, which most currently do not.
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