Support for the new cervical cancer vaccine for young females is growing since its approval by the U.S. Food and Drug Administration last June. Texas governor Rick Perry recently issued an executive order to require that school girls age 11 and 12 receive Merck's human papillomavirus (HPV) vaccine. In addition, the Washington, DC City Council recently introduced a bill that would require girls to be vaccinated before the start of sixth grade. Several other states have similar legislation pending. In clinical trials prior to its approval, the vaccine was shown to be 100% effective at preventing certain strains of a virus that can cause the disease. The vaccine is recommended for young females-ages 11 or 12. It is supported by the FDA, the Centers for Disease Control and Prevention, and several other health groups.
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," said Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS). "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."
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 vaccine is approved for use in females 9-26 years of age. However, the vaccine is most effective when 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.
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, worried 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.
- The June 4, 2006 Imaginis.com report, "FDA Advisory Panel Backs Cervical Cancer Vaccine," is available at http://www.imaginis.com/cervical-cancer/news/news6.04.06.asp
- The June 8, 2006 National Cancer Institute news release, "Statement from the National Cancer Institute on FDA Approval of the HPV Vaccine," was published on the NCI website at http://www.cancer.gov/
- The Centers for Disease Control and Prevention provides information on the cervical cancer vaccine at http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm
- Imaginis.com provides detailed information on cervical cancer screening, diagnosis, and treatment at http://www.imaginis.com/cervical-cancer/
