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Educate the Educators
Sponsored by the ASCCP
Frequently Asked Questions
During our training sessions a number of really good questions are being asked. These are
some of the most frequently asked questions together with the faculty's responses.
When will the vaccine be available?
The quadrivalent (HPV 6, 11, 16, 18) vaccine was approved for clinical use the first of June
2006 and is now available for clinical use.
What is the primary target population?
The Advisory Committee on Immunization Practices (ACIP) recently recommended to the CDC
that the primary target population for vaccination be 11-12 year old females. However,
vaccination can be give to girls as young as 9 years of age at the discretion of the patient's
clinician.
Can I vaccinate women who have been sexually active?
It is true that the HPV vaccines are prophylactic vaccines and that it is best to administer them
prior to the onset of sexual activity. However, ACIP in their recent recommendation stated that
women 13 - 26 years who have been sexually active should receive the vaccination.
When vaccinating sexually active women should I test for HPV?
To date there are no recommendations for whether or not you should test sexually active
women for HPV prior to vaccinating them. What we know is that vaccinating a woman already
Educate the Educators
HPV and the New HPV Vaccines
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infected with the vaccine HPV types does not result in an adverse reaction. We also know that
HPV DNA testing using the current generation of commercially available tests will not be useful.
This is because these tests have been calibrated to detect women at risk for high-grade CIN,
not women who are HPV infected. Many women who are infected with a high-risk type of HPV
will be HPV DNA negative using the most widely utilized HPV DNA test (Hybrid Capture 2 HPV
DNA Assay). It also should be pointed out that these tests do not tell you whether a woman has
specific vaccine HPV types; they tell you only whether or not a woman is positive for any one of
the 13 "high-risk" types of HPV.
Can I vaccinate pregnant women?
The quadrivalent HPV vaccine is classified as a Pregnancy Category B agent; therefore, it
should not be used in pregnant women. In the clinical trials, the series was stopped in women
who became pregnant during the 6-month vaccination period, and completed upon resolution of
the pregnancy.
Is it OK to vaccinate a 30 year old woman who requests vaccination?
The vaccine is approved for use in females 9 - 26 years of age. Therefore vaccinating an older
woman would be "off recommendation". It is also important to recognize that there is no data
demonstrating efficacy in women over the age of 26 years. Having said this, because the
vaccine is so efficacious in younger women it is likely that it will prove beneficial in older women
who are at risk for exposure to vaccine HPV types.
Might it be useful to vaccinate a patient with persistent CIN or HPV infection?
The current vaccines do not appear to have any therapeutic value and in the Phase III trial of
Gardasil there was no benefit seen to vaccinating women who were already HPV DNA positive
for the vaccine HPV types.
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Can I vaccinate males?
There is currently no data to demonstrate efficacy of vaccination in males and until such data is
available males should not be vaccinated.
What will vaccination cost?
According to statements from Merck, the list price of the vaccine is $120 per dose. Since three
doses are required over a six month interval, the total cost of vaccination including office visits is
likely to be approximately $500.00.
Will the HPV vaccine be included in the Vaccines for Children Program (VFC)?
The ACIP also recommended in June 2006 that the vaccine be included in the VFC program.
This is a very important milestone in helping achieve widespread coverage in the U.S. since
about 55% of childhood vaccines are paid for through the federally-funded VFC and 317
programs.
Are insurance companies covering vaccination?
In general, insurance companies pay for all vaccines included in the VFC program. Having said
this, it may take a while for the numerous different companies to cover HPV vaccination. It also
needs to be remembered that many plans have high deductibles for preventive services.
How is the vaccination given? Is it like a "flu shot"?
The vaccine is to be administered intramuscularly either into the deltoid muscle of the arm or the
high anteriolateral area of the leg. Each patient receives three 0.5 ml doses given according to
the following schedule:
First dose - at elected date
Second dose - 2 months after the first dose
Third dose - 6 months after the first dose
