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| How common is human papillomavirus (HPV)
infection? |
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| HPV is the most common sexually
transmitted infection in the United States. Currently, more than 20
million men and women in the United States are infected with HPV, and
more than 6 million are estimated to become infected each year. HPV is
most common in young women and men in their late teens and early 20s. By
age 50, at least 80 percent of sexually active women will have acquired
HPV infection. |
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| How serious is disease caused by HPV? |
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| HPV infection can lead to cervical
cancer in women as well as to other cancers that can affect males or
females. Cervical cancer is diagnosed in more than 9,700 women each year
in the United States each year and causes 3,700 deaths. Seventy percent
of cervical cancers are caused by strains of HPV included in the newly
licensed HPV vaccine. HPV also causes genital warts in men and women. |
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| Please provide more information about
the two HPV vaccines, Cervarix (GSK) and Gardasil (Merck). What are the
differences between them? |
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| Cervarix is an inactivated bivalent
vaccine (HPV2) that protects against HPV types 16 and 18. Gardasil is
an inactivated quadrivalent vaccine (HPV4) that protects against HPV
types 16 and 18, and also against types 6 and 11, which are human
papillomaviruses that cause genital warts. |
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| What are the CDC recommendations for
use of HPV vaccine? |
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| For prevention of cervical cancers and precancers,
ACIP recommends that females ages 9 through 26 years be vaccinated with either
Cervarix or Gardasil. To prevent genital warts, as well as cervical cancers and
precancers, ACIP recommends vaccination with Gardasil. Gardasil may also be
given to males ages 9 through 26 years to reduce their likelihood of acquiring
genital warts.
Ideally, HPV vaccine should be administered before
potential exposure to HPV through sexual contact. Therefore, for prevention of
cervical cancers and precancers, ACIP recommends that females ages 11 or 12
years be routinely vaccinated with either Cervarix or Gardasil. HPV vaccination
also is recommended for females ages 13 through 26 years who have not been
previously vaccinated or who have not completed the full vaccination series. The
vaccination series can be started in males and females beginning at age 9 years.
Both HPV vaccines are administered in a 3-dose
schedule, with the second dose administered 1 to 2 months after the first dose
and the third dose 6 months after the first dose. The minimum interval between
the first and second doses of vaccine is 4 weeks. The minimum interval between
the second and third doses of vaccine is 12 weeks. The minimum interval between
the first and third doses is 24 weeks.
Whenever possible, use the same brand of HPV vaccine
for all doses in the series. In situations when that's not possible, use the
second HPV brand to complete the series. A total of 3 doses of HPV vaccine
(either of a single brand or of a combination of brands) completes the series.
Do not start the series over again. If fewer than 3 doses of Gardasil are
received, protection against HPV types 6 and 11 may not be adequate.
Read the ACIP recommendations from CDC at www.cdc.gov/vaccines/pubs/acip-list.htm. |
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| What are the recommendations for
using Gardasil to prevent genital warts in boys and men? |
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| On October 21, 2009, ACIP provided
guidance that HPV4 (Gardasil) may be given to males ages 9 through 26
years to reduce their likelihood of acquiring genital warts; ACIP does
not recommend HPV4 for routine use among males. The schedule and minimum
intervals are the same as for females. See the question and answer above
for details. |
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| Use of HPV vaccine is
covered under the Vaccines For Children (VFC) program. Can VFC-eligible
boys receive HPV vaccine under the program? |
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| Yes. Since ACIP states that
Gardasil can be administered to males to protect them from genital
warts, VFC vaccine provided by the VFC program can be used for VFC-eligible
males ages 9 through 18 years. |
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| Are pap smears still necessary for
women who receive HPV vaccine? |
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| Yes. Vaccinated women still need to see
their healthcare provider for periodic cervical cancer screening. The
vaccine does NOT provide protection against all types of HPV that cause
cervical cancer, so even vaccinated women will still be at risk for some
cancers from HPV. |
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| Do women whose sexual preference is
women need HPV vaccine? |
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| Eligibility for HPV vaccine is not
determined by sexual preference. The vaccine is recommended for all
females age 11-12 years, and catch-up vaccination for all females age
13-26 years as long as there are no contraindications (e.g., pregnancy).
Though most HPV transmission occurs with sexual intercourse, the virus
can be transmitted through sexual activity that does not involve
penetration. It rarely can be transmitted through non-sexual routes
(e.g., mother to newborn at time of birth). |
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| What is the recommended schedule for
administering HPV vaccine? |
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| Both HPV vaccines should be administered
in a 3-dose schedule, with the second dose administered 1 to 2 months
after the first dose and the third dose 6 months after the first dose.
The minimum interval between the first and second doses of vaccine is 4
weeks. The minimum interval between the second and third doses of
vaccine is 12 weeks. The minimum interval between the first and third
doses is 24 weeks. |
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| If a dose of HPV vaccine is significantly
delayed, do I need to start the series over? |
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| No, do not restart the series. Just pick
up where the patient left off and complete the series. |
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| To accelerate completion of the human
papillomavirus (HPV) vaccine series, can doses be given at 0, 1, and 4 months? |
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| No, there is no accelerated schedule for
completing the HPV vaccine series. You should follow the recommended
schedule of 0, 1-2, and 6 months. |
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| CDC recommendations state that the minimum intervals for HPV vaccination
are at least 4 weeks between doses #1 and #2, and at least 12 weeks between doses #2 and #3. This adds up to a total of 16 weeks between
doses #1 and #3. But the recommendations also say that there must be a minimum of 24 weeks between doses #1 and #3. This doesn't make sense to
me. |
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| When administering HPV vaccine, you must
meet ALL the minimum intervals. For example, if you give dose #2 at a
minimum interval of 4 weeks after dose #1, you must wait 20 weeks to
give dose #3 in order to meet the 24-week minimum interval between #1
and #3. Determination of these minimum intervals was based on extensive
discussion with the manufacturers and on data from the HPV clinical
trials. For detailed information on minimum ages and intervals, see
table 1 as published in CDC's "General Recommendations on Immunization"
at www.cdc.gov/vaccines/pubs/ACIP-list.htm |
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| If a patient's vaccination history indicates she
received the third dose of HPV vaccine earlier than the recommended minimum
interval of 24 weeks, should she be given a fourth dose? |
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| Maybe. If the 3-dose series was given in
16 weeks or more, do not repeat any doses. If the 3-dose series was
given in less than 16 weeks, repeat dose #3 at least 12 weeks after the
invalid dose. |
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| I work with university students and many of them
miss coming in on time for their next dose of HPV vaccine. What's the longest
interval allowed before we need to start the series over? |
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| No vaccine series needs to be restarted
because of an interval that is longer than recommended (with the
exception of oral typhoid vaccine in certain circumstances). You should
continue the series where it was interrupted. If the HPV series is begun
when the university student is age 26 or younger, it can be completed
after she turns 27. It's important to rely on the actual
recommendations, not urban legends or guesswork. All ACIP
recommendations can be accessed at www.immunize.org/acip. ACIP's "General Recommendations on
Immunization" are especially useful: www.cdc.gov/mmwr/PDF/rr/rr5515.pdf |
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| Can a person (female or male) complete the HPV
series after age 26 years? |
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| The series should be completed, even if
this means that the series is completed after the person turns 27. |
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| We inadvertently gave HPV #1 to a woman who
didn't know she was pregnant at the time. How should we complete the schedule? |
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| First, you should report the vaccination
incident to the Merck registry at (800) 986-8999 (for Gardasil) or to
the GlaxoSmithKline registry (888-452-9622) for Cervarix. Second,
withhold further HPV vaccine until she is no longer pregnant. Shortly
after the pregnancy is completed, administer HPV#2 assuming 1-2 months
have passed since HPV#1. Give HPV#3 6 months after HPV#1, but
no earlier than 12 weeks after HPV#2. |
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| Can HPV vaccine be administered at the same time
as other vaccines? |
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| Yes, coadministration of a different
inactivated or live vaccine, either simultaneously or at any time before
or after HPV vaccine, is permitted because neither HPV vaccine is a live
vaccine. |
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| If a 30-year-old female patient
insists that she wants to be given HPV vaccine, can I give it to her? |
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| HPV vaccine is not FDA-licensed for use
in women older than age 26 years at this time. Studies are currently
being conducted in women age 27 years and older. ACIP does not recommend
the use of this vaccine outside the FDA licensing guidelines; however,
many physicians administer this vaccine as off-label use. There is no
reason to believe the vaccine would be any less safe for women in this
age group than for younger women. Clinicians should decide if the
benefit of the vaccine outweighs the hypothetical risk. |
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| Contraindications and precautions to vaccine |
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| A patient received human
papillomavirus (HPV) vaccine before she knew she was pregnant. What
should I tell her? |
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| HPV vaccine has not been causally
associated with adverse outcomes of pregnancy or adverse events to the
developing fetus. However, data on vaccination during pregnancy are
limited. If a woman is found to be pregnant after initiating the
vaccination series, delay completion of the series until after the
pregnancy. If a dose is administered during pregnancy, there is no
indication for intervention You should report the vaccination incident
to the Merck registry at (800) 986-8999 (for Gardasil) or to the
GlaxoSmithKline registry (888-452-9622) for Cervarix. More information
on HPV vaccination during pregnancy is available in the package inserts
at www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and http://us.gsk.com/products/assets/us_cervarix.pdf. |
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| If a woman is diagnosed with HPV,
should she still be vaccinated? |
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| Yes. Although the vaccine would not
alter the clinical course of the current infection, she would still
benefit from protection against the other virus types in the vaccine. |
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| If a woman has had HPV infection, can
she still be vaccinated? |
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| Yes. Women who have evidence of present
or past HPV infection and who are younger than age 27 years should be
vaccinated. They should be advised that the vaccine will not have a
therapeutic effect on existing HPV infection or any cervical lesions. |
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| Can a woman who is breastfeeding
receive HPV vaccine? |
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| Yes. |
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| Is the history of an abnormal pap a
contraindication to the HPV vaccine series? |
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| No. Even a woman found to be infected
with a strain of HPV that is present in the vaccine could receive
protection from the other 3 strains in the vaccine. |
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| We've heard stories in the media
lately about severe reactions to the HPV vaccine. Is there any substance
to these stories? |
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| No. In summer 2008 some
concerns were raised over two issues-reports of deaths and reports of
Guillain-Barrè syndrome (GBS)
following vaccination with Gardasil. As of August 2008, Merck reported
it had distributed more than 20 million doses of Gardasil in the United States. The Vaccine Adverse Events Reporting
System (VAERS) had received reports of 27 deaths. CDC
reported that there was not a common pattern to the deaths; if there had
been a common pattern, it would suggest the deaths
might be caused by the vaccine. Occurrences of GBS, a rare neurological
disorder, have been reported through VAERS. FDA and
CDC reviewed the reports and found no evidence that Gardasil increased
the rate of GBS above what is expected in the
population. CDC, working with the FDA and other immunization partners,
will continue to monitor the safety of Gardasil. You
can find complete information on this and other vaccine safety issues at www.cdc.gov/vaccinesafety. |
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| What is the Current Procedural
Terminology (CPT) code for HPV vaccine? |
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| The CPT codes for HPV vaccines, used for
billing purposes, are 90649 for Gardasil (Merck) and 90650 for Cervarix
(GSK). |
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| Reviewed on 7/10 |
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