Gardasil Approved to Prevent Three HPV-Related Cancers

A few weeks ago I wrote an article wondering if the popular human papillomavirus (HPV) vaccine Gardasil—known in some countries as SILGARD®—was fast becoming the “food bunker of the New Millennium”  first by being approved very quickly by the Food and Drug Administration (FDA) and then with advertisements shoved into our faces like a child’s unwanted spinach. I thought maybe we had jumped on the bandwagon too soon. However, it seems we have new evidence to suggest the contrary that Gardasil may actually prevent more in young women than just HPV, the cause of 70 percent of cervical cancers, along with genital lesions and genital warts.

A few days ago, Merck—the pharmaceutical company that produces and distributes Gardasil—announced that this vaccine can also prevent against cancers of the vagina and the vulva, cancers which occur in about 5,000 women in the United States each year. Approved in 2006 by the FDA, Gardasil has been promoted as preventing four strains of HPV that can lead to cervical cancer. Turns out two of those strains of the human papillomavirus are responsible for more than half of the cases of vaginal and vulva cancers, so the preventative measures of the vaccine should protect against all three types of gynecological cancers.

Known as HPV, it has over 100 branches included within it and over 30 of those viruses can be spread through sexual contact. A lot of times, a woman’s body fights off the virus on its own and she will not even know she has it, but the times that the body doesn’t fight it off, abnormal growth of the cells can occur and eventually lead to cancer.

While uterine, cervical and ovarian cancers have been receiving a lot of publicity over the last few years with rising diagnoses and awareness-raising for research costs, cancers of the vagina and vulva have been making their home just under the radar. In a news release, the FDA’s director for Biologics Evaluation and Research, Jesse L. Goodman says, “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

To conduct the study for rare gynecological cancers caused by HPV, scientists looked at 15,000 women that had previously participated in the Gardasil trials and continued to watch them for two more years. Half of them had been given the Gardasil vaccine and the other half—the control group—had not. In looking for precursors to cancer, vaginal or vulvar lesions, the vaccinated women (who had not previously had HPV) did not have any precancerous lesions. Out of the control group, ten women had vulvar precancerous lesions and nine had vaginal precancerous lesions. The vaccine was not beneficial to women that were already carrying the HPV virus, which reinforces the age limit of the drug.

While it is still only approved for girls and young women ages 9 to 26, scientists are continually working on a vaccine to protect women in a larger age bracket, but research takes time. In response to using the vaccine to treat women ages 27 to 45, Merck Vaccines and Infectious Diseases Adolescent/Adult Vaccines general manager and senior vice president Beverly J. Lybrand says, "Merck is proud that Gardasil continues to be the world's leading cervical cancer vaccine.  We are committed to seeing Gardasil used to help prevent cervical cancer and other HPV diseases in the currently indicated population….We will continue to pursue this and other supplemental approvals to extend the use of this vaccine to others." Despite the younger generations being able to receive the vaccine, researchers and doctors still warn them that it isn’t enough. Even with the vaccine, regular gynecological exams and cancer screenings are still needed.