Gardasil Indications Expanded to Include Vaginal and Vulvar Cancers

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Merck has won FDA approval to market Gardasil, which immunizes patients against cancer-causing strains of the human papillomavirus (HPV), as a preventive vaccine for vaginal and vulvar cancers, as well. According to the American Cancer Society, about 2140 new cases of vaginal cancer and 3490 of vulvar cancer are diagnosed each year, many of which are caused by strains of HPV, and ~1760 women die from these diseases annually.

In a recently released statement from the FDA’s Center for Biologics Evaluation and Research, Jesse L. Goodman, director, said that there was strong evidence that Gardasil could help prevent vulvar and vaginal cancers caused by the same viruses that cause cervical cancer. “While vulvar and vaginal cancers are rare,” the release stated, “the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

The FDA initially approved Gardasil in 2006 to protect females aged 9 to 26 years against the 4 strains of HPV identified as causing 90% of cases of genital warts and 70% of cervical cancer cases. Industry analysts speculate that the expanded indications will likely give Merck’s vaccine a crucial edge in the marketplace over its current and future competitors, such as Cervarix. GlaxoSmithKline has been seeking FDA approval to market Cervarix in the United States, but the FDA delayed approval in December 2007.

Gardasil remains one of Merck’s most promising new drugs and racked up $1.5 billion in sales last year. Sales dropped 9% in the second quarter of 2008, however, because many younger girls had already been vaccinated and demand for Gardasil among older women has been less than expected, Merck's spokesperson said.

The vaccine’s critics include various groups that advocate abstinence before marriage, and they claim Gardasil may have safety issues and gives women a false sense of security about their risk of contracting a sexually transmitted disease. Judicial Watch is a Washington-based organization that is pushing for full disclosure of the vaccine’s adverse effects. The group has also argued that no state should mandate that girls receive Gardasil vaccination, something several states had considered doing when Gardasil came on the market, and that it should not be prescribed to girls <18 years of age.