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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 anogenital cancers that can affect
males or females.
Cervical cancer is diagnosed in more than 12,000 women each year in
the United States each year and causes 4,200 deaths.
Seventy percent of cervical cancers are caused by HPV types 16 and 18,
which are included in both licensed HPV vaccines. HPV types 6 and 11
also cause over 90% of 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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ACIP recommends that all males and
females ages 11 through 12 years be routinely vaccinated with a 3-dose
series; either HPV2
(Cervarix) or HPV4 (Gardasil) may be used in females, and only HPV4 (Gardasil)
should be used in males. HPV vaccination is
also recommended for females through age 26 years and males through
age 21 years who have not completed or begun a 3-dose
series. In addition, vaccination is recommended for men age 22 through age 26 years who 1) have sex with men or 2) are
immunocompromised as a result of infection (including HIV), disease,
or medication. Ideally, HPV vaccine should be
administered before potential exposure to HPV through sexual contact.
The vaccination series can be beginning as young as age
9 years at the clinician's discretion.
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Both HPV vaccines should
be given as a 3-dose schedule, with the second dose
given 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 given to
females. In
situations when that's not possible, use the second HPV
brand to complete the series. It is not necessary to
start the series
over. For more information, see the ACIP recommendations
from CDC at
www.cdc.gov/vaccines/pubs/acip-list.htm. |
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Please describe the new
recommendations for the use of HPV4 vaccine in males and explain how
these new recommendations differ
from the previous ones. |
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| ACIP recommends routine vaccination of
males age 11–12 years with HPV4 (Gardasil, Merck) administered as a
3-dose series. The vaccination series can be started beginning at age
9 years. Vaccination with HPV4 is recommended for males age 13 through
21 years who have not been vaccinated previously or who have not
completed the 3-dose series. Males age 22 through 26 years may be
vaccinated with HPV4.
ACIP recommends that
immunocompromised males who have not been vaccinated
previously or who have not completed the 3-dose
series receive routine vaccination with HPV4 through age
26 years.
Men who have sex with men
(MSM) are at higher risk for infection with HPV types 6,
11, 16, and 18 and associated conditions,
including genital warts and anal cancer. ACIP recommends
that MSM who have not been vaccinated previously or who
have not
completed the 3-dose series receive routine vaccination with HPV4 through age 26 years. Previously, ACIP had
issued
permissive recommendations for HPV4 use in males age
9–26 years for the prevention of genital warts.
To obtain a copy of the
new recommendations, which were published in MMWR in
December 2011, see
www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm. |
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| Is use of HPV vaccine covered under
the Vaccines For Children (VFC) program? |
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| Yes. VFC-eligible females, ages 9
through 18 years, can be given either HPV2 (Cervarix) or HPV4 (Gardasil);
VFC-eligible
males, ages 9 through 18 years, should be given HPV4 (Gardasil). |
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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 and men whose sexual
orientation is same-sex need HPV vaccine? |
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| Yes. HPV vaccine is recommended for
females and males regardless of their sexual orientation. |
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| Will patients who have already had
genital warts benefit from receiving Gardasil? |
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| A history of genital warts or
clinically evident genital warts indicates infection with HPV, most
often type 6 or 11.
However, people with this history might not have been infected with
both HPV 6 and 11 or with HPV 16 or 18. Vaccination will
provide protection against infection with HPV vaccine types the
patient has not already acquired. Gardasil (HPV4) protects
against HPV vaccine types 6, 11, 16, and 18; Cervarix (HPV2;
GlaxoSmithKline) protects against HPV 16 and 18. Providers
should advise their patients/clients that results from clinical trials
do not indicate the vaccine will have any therapeutic
effect on existing HPV infection or genital warts. It is important,
however, that patients receive all 3 doses of HPV4
vaccine to get full protection from genital warts. |
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| If a patient has been sexually
active for a number of years, is it still recommended to give HPV
vaccine or to complete the
HPV vaccine series? |
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| Yes. You should not withhold HPV
vaccine from people who are already sexually active. Ideally, patients
should be vaccinated
before onset of sexual activity; however, patients who have already
been infected with one or more HPV types still get
protection from other HPV types in the vaccine that have not been acquired. |
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| Vaccination
scheduling and administration issues |
Back to top |
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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
with minimum intervals of at least 4 weeks between dose #1 and dose
#2, AND at least 12
weeks between dose #2 and dose #3, do not repeat any doses. If the
third dose was given at less than 12 weeks from dose #2,
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 the student 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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| Is it recommended that patients age
26 years start the HPV vaccination series even though they will be
older than 26 when
they complete it? |
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| Yes. HPV vaccine is recommended for
all women through age 26 years and also may be given to men through
that age. So, the 3-dose series can be started at age 26 even if it will not be completed
at age 26. The series should be completed regardless of
the age of the patient (i.e., even if the patient is older than 26).
In certain situations, some clinicians choose to start
the 3-dose HPV series in patients who are older than 26 years. This,
however, is an off-label use. |
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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 HPV vaccine is given
subcutaneously (SC) instead of intramuscularly (IM), does the dose
need to be repeated? |
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| Yes. No data exist on the efficacy or
safety of HPV vaccine given by the subcutaneous route. All data on
efficacy and
duration of protection are based on a 3-dose series given on the
approved schedule and administered by the intramuscular
route. In the absence of data on subcutaneous administration, CDC and
the manufacturers recommend that a dose of HPV vaccine
given by any route other than intramuscular should be repeated. There
is no minimum interval between the invalid
(subcutaneous) dose and the repeat dose. |
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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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| 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 September 2011, the
manufacturer of Gardasil (Merck) reported it had distributed
more than 40 million doses of Gardasil in the United States. At that
time, the federal Vaccine Adverse Events Reporting
System (VAERS) had received reports of 71 deaths, although only 34
could be confirmed. Among these 34 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.
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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 and Cervarix vaccines.
You can find complete
information on this and other vaccine safety issues at
www.cdc.gov/vaccinesafety/vaccines/HPV/gardasil.html. |
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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 4/12 |
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