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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 new HPV vaccine. |
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| Gardasil™, manufactured by Merck, is the first vaccine developed to prevent cervical cancer,
precancerous genital lesions, and genital warts due to HPV. The vaccine is highly effective against four types of the
HPV virus, including two that cause about 70 percent of cervical cancer. HPV-vaccine recipients who have
not acquired HPV would get the full benefits of the vaccine. Though women already infected with an HPV
vaccine type virus will not benefit from that part of the vaccine, they could still benefit from the other vaccine
virus types. |
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| What are the CDC recommendations for use of HPV vaccine? |
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CDC recommends that females age 11-12 years be vaccinated with 3 doses of HPV vaccine.
Additionally, HPV vaccine is recommended for all females age 13-26 years who have not been previously vaccinated
or who have not completed the full series. The vaccination series can be started as young as age 9
years. Ideally, vaccine should be administered before potential exposure to HPV through sexual contact;
however, females who are sexually active or who have had HPV infection or an abnormal Pap test should also
be vaccinated.
Gardasil™ is licensed as a 3-dose series, with dose #2 given 2 months after dose #1, and dose #3 given
4 months after dose #2. The minimum interval between doses #1 and #2 is 4 weeks, and between doses
#2 and #3 is 12 weeks. Overall, there must be an interval of at least 24 weeks between doses #1 and #3.
The vaccine should be given IM in the deltoid. For more information on the use of HPV vaccine, see the
ACIP recommendations from CDC at
www.cdc.gov/vaccines/pubs/acip-list.htm |
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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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| Since men transmit HPV, why isn't the vaccine recommended for them also? |
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Studies of the safety and immunogenicity among males are not yet complete. It is possible that HPV
vaccine will be recommended for males at a later date. |
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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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| CDC recommends dose #2 be given 2 months
dose #1, and dose #3 be given 6 months after dose #1. |
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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, 2, and 6 months. |
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What are the minimum intervals between doses? |
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| The minimum interval between dose #1 and
dose #2 is 4 weeks, and the minimum interval between doses #2 and #3 is
12 weeks. Overall, there must be an interval of at least 24 weeks
between doses #1 and #3. |
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If a patient receives the third dose of HPV
vaccine earlier than recommended, 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 woman 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 a woman 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. Second, withhold
further HPV vaccine until she is no longer pregnant. Shortly after the
pregnancy is completed, administer HPV#2. Give HPV#3 at 16 weeks after
HPV#2 and no sooner than 24 weeks after HPV#1. |
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Can HPV vaccine be administered at the same time
as other vaccines? |
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| Yes, it can. |
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| If a 30-year-old 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. Merck, the
vaccine's manufacturer, has established a registry of women who were vaccinated with HPV during pregnancy. You
or your pregnant patients should report an exposure to HPV vaccine; call (800) 986-8999. More information
on HPV vaccination during pregnancy is available in the package insert at
www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.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-Barre
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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| It is 90649. CPT codes are used for billing. |
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| Reviewed on 6/09 |
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