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Cervical Cancer Vaccine For Women 9 to 26 Years Old

Gardasil, a vaccine against the virus that causes most cervical cancers, most cancers of the vagina and vulva, and genital warts has been approved by the FDA. It's use has also been widely supported by Ob/Gyn's, Family Practitioners and Pediatricians.

"FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women's health in recent years," states the American Cancer Society in a news release.

The vaccine protects against infection from four strains of the human papilloma virus, or HPV. Two of these strains, HPV-16 and HPV-18, account for about 70% of cervical cancers. The other two strains covered by the vaccine, HPV- 6 and HPV-11, account for about 90% of genital warts.

"Gardasil is a major health breakthrough -- the first vaccine specifically designed to prevent cancer -- and is approved to prevent not only cervical cancer but also genital warts," says Kevin Ault, MD, leader of Gardasil clinical trials at Atlanta's Emory University, in a Merck news release.

The vaccine is approved for use by 9 to 26 year-old girls and women. While it is almost always females who get HPV-related cancer, the virus is spread by both men and women during sexual contact and both men and women are susceptible to genital and rectal warts, which can lead to cervical changes and abnormal Pap smears in women.

Gardasil is currently not approved for use by boys and men but clinical trials evaluating Gardasil vaccination in this population are underway.

Effective and Safe

In all clinical trials reported so far, the vaccine has been shown to be extremely effective. It appears to be 100% effective in protecting against the HPV-16 and HPV-18 strains. It also seems extremely safe. One reason is that the vaccine isn't a live virus, but a virus-like particle. This means it's an empty shell, with immunity-stimulating particles on the outside and no viral machinery on the inside.

HPV expert Jessica Kahn MD, MPH, Associate Professor of Pediatrics at Cincinnati Children's Hospital Medical Center, says she's planning to have her teenage daughter vaccinated.
"What we parents most want to know about the vaccine is whether it is safe, and whether it is effective. All data show it to be one of the safest vaccines ever tested. And it is highly effective."

To be effective, Gardasil must be given in three doses over six months (the second dose is given two months after the first; the third dose six months after the first). It's not yet clear whether a person will receive lifelong immunity. So far,in tests checking for acquisition of the virus after vaccination, the vaccine remains protective for at least four years and counting.

The wholesale price for Gardasil is $120 per dose; $360 for all three doses. Most insurance companies have agreed to cover the cost of Gardasil for use in girls and women ages 9 to 26.

Pap Screening Still Needed

Despite its potency, Gardasil won't prevent every cervical cancer or every HPV infection. There are some 100 HPV strains out there. Those covered by the vaccine are the worst offenders, but not the only ones.

Gardasil will not prevent disease in people already infected with the virus. Perhaps as many as 80% of adults have been exposed to at least one strain of HPV. For reasons not fully understood, only a minority of people with HPV get cervical cancer or warts.

"This vaccine only prevents infection. It does not prevent disease once you are already infected with the virus," Kahn says. "The vaccine does not treat precancerous conditions."

This means that while the vaccine undoubtedly will prevent many of the annual 3,700 U.S. and 233,000 worldwide cervical-cancer deaths, it will not end cervical cancer, genital warts, or the spread of other strains of HPV.

"One of the points I am going to try to get across to women is to stress that even after getting the vaccine, they must continue to get regular Pap screening," Kahn says. "Some vaccinated women will still have abnormal Pap tests. It does not mean the vaccine is not working. Some abnormal Paps are caused by strains of HPV that are not in the vaccine."

The Role of Parents

Vaccines don't work if people don't use them. Researchers think that Gardasil will work best if given to teens before they become sexually active, that is, at ages 11 to 13.

HPV is a sexually transmitted disease. Will parents object to vaccinating their teens?

Some will, but the vast majority won't, predicts Gregory D. Zimet, PhD, Professor of Pediatrics and Clinical Psychology at Indiana University School of Medicine, Indianapolis. Zimet has studied parental attitudes toward vaccines, including vaccines that would protect against sexually transmitted diseases.

"There has been this idea that giving an HPV vaccine to teens might be seen by parents as giving their daughters permission to have sex, or that it might lower some kind of barrier and lead to a sense of safety that would lead that young adolescent to engage in sex that they would not otherwise have." But when Zimet and colleagues asked parents what their concerns would be about an STD vaccine, this wasn't a common opinion. Instead, parents wanted to know how safe the vaccine was, how well it worked, and whether the disease it prevented was serious.

"There had been some concern that doctors might be reluctant to prescribe STD vaccines because of anticipated parental opposition," Zimet says. "But research indicates parents have great eagerness to have their children vaccinated against these diseases."

All of the providers at The Women's Healthcare Group are extremely excited about the potential benefits of Gardasil and the tremendous effect it will have on reducing the vast majority of cervical, vulvar and vaginal cancers as well as genital warts. We plan to encourage all of our patients ages 9 to 26 to get the 3 dose vaccine regimen. For girls under 18 years of age who receive their primary care from a pediatric practice, we encourage them and their parents to discuss Gardasil with their pediatrician. As stated earlier, each of the 3 doses of Gardasil will cost $120. Fortunately, our recent survey of insurance companies in the area has shown that most will cover the cost of the vaccine regimen. We encourage you to check out www.gardasil.com for more information.

Please feel free to discuss Gardasil with any of the providers at The Women's Healthcare Group. We hope you will share our enthusiasm for this medical breakthrough in the area of women's health!

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