FDA awaits advisory panel decision about Gardasil vaccine for boys

An advisory panel to the U.S. Food & Drug Administration (FDA) is expected to decide by the end of the year whether it will recommend expanding the use of the HPV vaccine, Gardasil, for use in boys and young men. The drug, which targets the Human Papillomavirus and is currently recommended for use in girls and young women for the prevention of cervical cancer, is currently approved, but not recommended, for young men to prevent genital warts.

If the advisory panel finds there is sufficient clinical data to show that the vaccine would prevent anal lesions and anal cancer in men, it could advise that the FDA change the drug’s status to “recommended” for boys and young men as well.

According to a recent report on, the recommendation could be controversial.  The use of this vaccine already has sparked a debate about whether or not its use suggests a “free pass” to young people to have sexual intercourse because they feel it protects them from disease. Adding to the controversy about the vaccine for boys, is whether or not to advocate the vaccine for all boys, or only those who have determined they are gay or bisexual.

Studies show the group most likely to benefit from the Gardasil vaccine among young men are those who have sex with other men. In this group, the vaccine has shown to be 78 percent effective at preventing anal lesions and anal cancer, reports.  However, researchers wonder if a targeted vaccine would miss much of its intended audience because it is given at such a young age that a boy making the decision to be vaccinated – or his parents – would be unaware that he is gay. Also, experts think a targeted vaccine might not be effective because young men who do feel they are gay may avoid getting the vaccine because they think it may stigmatize them, exposing them to harassment or judgment.

On the other hand, physicians are hesitant to recommend the vaccine for all boys, when studies show it would be largely ineffective or unnecessary for the majority of boys who might receive it, who are at very small risk. According to U.S.’s Health report, complications from HPV for young men are quite rare. “For the average guy,” the report states, “the virus lies silent, doesn’t cause problems, and clears in a year or two.”

The FDA is expected to make its decision whether or not to expand the marketing of Gardasil as “recommended” for boys by the end of the year. After that, the federal Advisory Committee on Immunization Practices (ACIP) will determine whether to issue its own public recommendation. That decision should occur around February 2011.

Sources:; US