Cervical Cancer Vaccine

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, but it does 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 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. The vaccine does not eliminate the need for the Pap test because it only protects against four strains of HPV.

Gardasil, the cervical cancer prevention vaccine, 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. The retail price of the vaccine is $120 per dose ($360 for full series). 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.

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

• The February 13, 2007 Imaginis.com report, Cervical Cancer Vaccine Gains Support, is available at here
• To learn more about the human papillomavirus (HPV), please visit here

Updated: June 4, 2008