Gardasil gets expanded use approval from FDA

October 13, 2008

In addition to its earlier FDA approval for prevention of cervical cancer, Gardasil has received FDA approval for use in preventing vaginal and vulvar cancers in girls and women age 9 to 26.

Key Points

The U.S. Food and Drug Administration recently announced that the vaccine Gardasil has been approved for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in females ages nine to 26. The agency said these two types of HPV cause 70 percent of cervical cancers and also cause some vulvar and vaginal cancers.

"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancers," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.