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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.
Additional Resources and References
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