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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
Updated: June 4, 2008
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