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FDA Approves Gardasil Use in Males Aged 9–26


 

The Food and Drug Administration has approved the Gardasil vaccine for boys and men aged 9-26 years to prevent genital warts associated with the human papillomavirus, according to a statement from the vaccine's manufacturer, Merck & Co. An FDA press officer confirmed the approval.

The human papillomavirus (HPV) vaccine offers protection against four strains of the virus (types 6, 11, 16, and 18) that have been associated with the most disease, including cervical cancer in women (types 16 and 18) and genital warts in both women and men (types 6 and 11), according to the statement.

In an Oct. 21 vote, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) declined to recommend routine use of Gardasil in males aged 9-26 years, letting physicians decide whether to use the vaccine. The vaccine was approved in 2006 for young women and girls aged 9-26 years, and it is part of the CDC's adolescent vaccination schedule.

Gardasil is not recommended for pregnant women or for individuals with hypersensitivity to yeast, according to the vaccine's safety information.

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