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Cervical Cancer Vaccine (Gardasil)

In 2006, the U.S. Food and Drug Administration announced its approval of a vaccine to prevent cervical cancer. The vaccine does not prevent all forms of cervical cancer, and thus it is important for women to receive regular Pap tests to screen for the disease. However, the vaccine has been shown to prevent certain types caused by a commonly sexually transmitted disease called the human papillomavirus (HPV).

There are over 80 different strains of HPV, affecting more than 40 million Americans. While the majority of HPV strains do not pose health risks, a few strains increase the risk for cervical cancer (such as HPV-16, HPV-18, HPV-31, and HPV-45). Clinical trial results presented to the FDA advisory panel in May 2006 showed that a vaccine called Gardasil blocked four strains of human papillomavirus. In studies of over 20,000 women ages 16 to 26, Gardasil prevented 100% of cervical, vaginal, and vulvar pre-cancers caused by HPV types 16 and 18. Gardasil was also shown to be highly effective at preventing cervical and external genital lesions due to one of four strains of HPV (6, 11, 16, 18). The most common side effect is soreness at the injection site (arm). The vaccine does not eliminate the need for the Pap test because it only protects against four strains of HPV.

The vaccine, Gardisil, is administered in a series of 3 injections over a 6-month period. The second injection is given 2 months after the first one, and the third is given 4 months after the second. Side effects are said to be mild. The most common side effect is soreness at the injection site (arm), as well as temporary redness and swelling. The vaccine does not eliminate the need for the Pap test because it only protects against four strains of HPV.

Gardasil is approved for use in females 9-26 years of age. However, the vaccine is most effective if administered before an individual becomes sexually active. Therefore, experts recommend that girls start getting it at age 11 or 12. According to the Centers for Disease Control and Prevention, the vaccine is also recommended for 13-26 year-old girls/women who have not yet received or completed the vaccine series. By contrast, the American Cancer Society (ACS) states that "catch-up" vaccinations should be given to females aged 13 to 18. The ACS's independent panel that makes recommendations to the ACS found that there was not sufficient proof of benefit to recommend catch-up vaccinations for every woman aged 19 to 26 years. As a result, the ACS recommends that women aged 19 to 26 talk with their health care provider about the risk of previous HPV exposure and potential benefit from vaccination before deciding to get vaccinated.

The retail price of the vaccine is $130 per dose ($390 for full series) in addition to physician fees. The vaccine is given through a series of three shots over a six-month period. Some insurance plans may cover the vaccine; patients are strongly encouraged to contact their insurance companies before receiving any medical test or vaccination. U.S. government programs that cover vaccines for children under age 18 cover the cost of Gardisil.

In announcing the FDA's approval of the vaccine on June 8, 2006, Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS) said in the FDA's news release, "Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer. HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans."

The vaccine has been somewhat controversial. Some conservative groups have voiced concern about giving a vaccine that blocks a sexually transmitted disease to young girls, worrying that the vaccine could inadvertently encourage sexual activity. However, groups such as the Family Research Council have applauded the vaccine, noting that it will be a personal choice for parents and their daughters.

Males also carry HPV, but currently, it is unknown whether the vaccine would protect against HPV infection in males. Studies are underway to examine this issue and to determine whether the vaccine would have other benefits for males, such as preventing genital warts and rare cancers, such as penile and anal cancer.

Additional Resources and References

Updated: May 2010