Approximately 20 million people are currently infected with genital
human papillomavirus (HPV) in the United States (U.S.).1 As
many as half of these infections are among adolescents and young
adults, ages 15 through 24 years of age.2 HPV
is so common that most sexually active adults become infected at
some point in their lives.
Of the more than 40 types of HPV that infect human mucosal surfaces,
most infections are asymptomatic and transient. However, certain oncogenic
types can cause cervical cancer and other, less common anogenital cancers,
including cancers of the anus, penis, and vulva. Other, non-oncogenic HPV
types can cause genital warts and, rarely, respiratory tract warts in children.
Every year, about 12,000 women are diagnosed with cervical cancer,
and almost 4,000 women die from this disease in the U.S.3 About 1%
of sexually active men and women in the U.S. have genital warts at any
given time.4
The quadrivalent human papillomavirus (HPV) vaccine, Gardasil®,
is the first vaccine developed to protect against most cervical cancers
and genital warts. The three-dose vaccine is routinely recommended
for 11 and 12 year old girls. The vaccine series can be started at
9 years of age. Catch-up vaccination is recommended for 13 through
26 year old females who have not yet received or completed the vaccination
series.5
This prophylactic vaccine works by preventing four HPV types:
HPV 16 and 18, which cause 70% of cervical cancers, and HPV 6 and
11, which cause 90% of genital warts. The vaccine has no therapeutic effect on
HPV-related disease, so it will not treat existing diseases or conditions caused
by HPV.
The vaccine is made from non-infectious HPV-like particles (VLP).
It does not contain thimerosal or mercury as a preservative.
HPV Vaccine Recommendations
The HPV vaccine is routinely recommended for 11 and 12 year-old
girls. The vaccine series can be started at 9 years of age. Catch-up
vaccination is recommended for 13 through 26 year-old females who have
not yet received or completed the vaccine series.6
Ideally, females should be vaccinated before onset of sexual
activity, when they may be exposed to HPV. However, sexually active
females may also benefit from vaccination since few young women are
infected with all four HPV types targeted by the vaccine (6, 11, 16,
18). Females who already have been infected with one or more HPV types
would still get protection from the vaccine types they have not acquired.
Currently, there is no test available for clinical use to determine
whether a female has had any or all of the four HPV types targeted
by the vaccine.
The HPV vaccine can be given to females who:
Are lactating.
Have minor acute illnesses, such as diarrhea or mild upper respiratory
tract infections, with or without fever.
Have an equivocal or abnormal Pap test, a positive Hybrid Capture
II® high risk test, or genital warts. However, women should
be advised that data do not indicate that the vaccine will have
any therapeutic effect on existing Pap test abnormalities, HPV
infection or genital warts.
Are immunocompromised, either from disease or medication. However,
the immune response to vaccination and vaccine efficacy might be
less than in immunocompetent females.
The HPV vaccine should not be given to females who:
Are pregnant. Although the vaccine has
not been causally associated with adverse pregnancy outcomes or adverse
events to the developing fetus, data on vaccination in pregnancy
are limited. Any exposure to vaccine in pregnancy should be reported
to the vaccine pregnancy registry at (800) 986-8999.
Have a history of immediate hypersensitivity to yeast or
to any vaccine component.
Have moderate or severe acute illnesses. In these cases,
girls/women should wait until the illness improves before getting vaccinated.
HPV Vaccine Safety
The HPV vaccine has been studied in thousands of females (9 through
26 years of age) in many countries around the world, including the U.S. These
studies found that the HPV vaccine was safe and caused no serious side effects.
The most common adverse event was injection site pain. This reaction was
common but mild.
Since vaccine licensure, there have been reports of syncope after
vaccination. Syncope after any vaccination is more common in adolescents.
Providers should consider a 15-minute waiting period for vaccine recipients
following vaccination.
A detailed post-licensure safety monitoring plan, coordinated by
the FDA and CDC, is in place. For more information about the Vaccine Adverse
Events Reporting System (VAERS) visit www.vaers.hhs.gov
HPV Vaccine Efficacy and
Antibody Response
The efficacy of this vaccine has mainly been studied in young
women (16 through 26 years of age) who previously had not been exposed to
the targeted HPV types. These clinical trials demonstrated nearly 100% vaccine
efficacy in preventing cervical precancers, vulvar and vaginal precancers,
and genital warts caused by the four vaccine types. In women already infected
with a targeted HPV type, the vaccine did not prevent disease from that HPV
type but did protect against other vaccine types.789
Immunogenicity studies i also
have been conducted in girls, ages 9 to 15 years of age. Over 99% of vaccinated
girls in these studies developed antibodies after vaccination. Titers were
higher in these young girls, compared to older females in the efficacy trials
(ages 16 through 26 years of age).10
While it is possible that vaccinating males with the quadrivalent
vaccine may offer direct health benefits to males and indirect health benefits
to females, there are currently no efficacy data available to support use
of the HPV vaccine in males. Efficacy studies in males are ongoing. Information
should be available within the next few years.
The vaccine offers a promising new approach
to the prevention of HPV and associated conditions. However, it will
not replace other prevention strategies since vaccines will not work
for all HPV types.
i These
studies provide support that vaccine efficacy data can be extrapolated
from one population to another; in this case, from young adult women
(ages 16 through 26 yearsof age) to younger girls (ages 9 through
15 years of age).
Duration of Vaccine Protection
Studies suggest that vaccine protection is long-lasting. Current
studies (with about five years of follow-up data) indicate that
the vaccine is effective for at least five years, with no evidence
of waning immunity. This information will be updated as additional
data regarding duration of immunity become available.
HPV Vaccine Administration
The vaccine should be delivered through a series of three intra-muscular
injections over a six-month period. The second and third doses should be
given two and six months after the first dose.
The vaccine can be administered at the same visit as other age-appropriate
vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines.
Providers should consider a 15-minute waiting period for vaccine
recipients following vaccination.
Cervical cancer screening recommendations have not changed for females
who receive the HPV vaccine.
Covering the Cost of the
Vaccine
Children age 18 and younger may be eligible to get vaccines,
including the HPV vaccine, for free through the Vaccines for Children (VFC)
program if they are: Medicaid eligible; uninsured; or American Indian or
Alaska Native. Doctors can charge a fee to give each shot. However VFC
vaccines cannot be denied to an eligible child if the family cannot afford
the fee.
State and private programs offering free or low-cost vaccines
may also be available for eligible persons. Contact your State Health Department
to see if your state has such a program.
Vaccine providers should notify vaccinated females that:
It is important to get all three doses of the vaccine
to get its full benefits.
Women will still need regular cervical cancer screening, beginning
at age 21 or three years after initiating sexual activity, since
the vaccine will not protect against all HPV types that cause cervical
cancer.
They should continue to practice abstinence or protective sexual
behaviors (i.e., condom use), since the vaccine will notprevent
other sexually transmitted infections (STIs). Although condoms may
not fully protect against HPV, they may lower one’s chances
of getting HPV and developing HPV-related diseases, when used all
the time and the right way.11 Women
can also lower their chances of getting HPV by being in a mutually
faithful relationship with someone who has had no or few sex partners,
or by limiting their number of sex partners.
A bivalent HPV vaccine is now being considered for licensure by the FDA.
This vaccine would protect against the two types of HPV (16, 18) that
cause 70% of cervical cancers. It would not protect against genital
warts. Clinical trials in women ages 15 through 25 years of age have
demonstrated high vaccine efficacy in preventing cervical precancers
caused by HPV 16 and 18.12
Background: Cervical Cancer Prevention
Cervical cancer once claimed the lives of more American women than any other
type of cancer. But over the last 40 years, widespread cervical cancer screening
using the Pap test and treatment of pre-cancerous cervical abnormalities
have resulted in a marked reduction in cervical cancer incidence and mortality
in the U.S.13 New technologies, such as liquid-based cytology and an HPV DNA
test, are now commercially available and licensed for use in women for cervical
cancer screening and management, although they are not recommended by all
professional associations.
Today, as many as 82% of women in the U.S. have been screened with a Pap
test in the past three years.14 Despite this, U.S. screening programs are not
reaching all women in the U.S. It is estimated that half of the women diagnosed
with cervical cancer have never been screened for cervical cancer, and an
additional 10% have not been screened in the previous 5 years.1516 Cervical cancer
disproportionately affects women of lower socioeconomic status, without regular
access to health care, who are uninsured, and who are recent immigrants.1718
These populations stand to benefit most from HPV vaccination.
1 Weinstock H, Berman S, Cates W, Jr. Sexually transmitted diseases
among American youth: incidence and prevalence estimates, 2000. Perspect
Sex Reprod Health. 2004; 36(1):6-10.
2 Cates W, Jr. Estimates of the incidence and prevalence of sexually transmitted
diseases in the United States. American Social Health Association Panel.
Sex Transm Dis. 1999; 26(4):Suppl):S2-7.
3 United States
Cancer Statistics, National Program of Cancer Registries (NPCR). U.S.
Cancers by Type.
4 Koutsky LA, Galloway DA, Holmes KK. Epidemiology of genital human papillomavirus infection. Epidemiol Rev. 1988; 10:122-163.
5 Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER. Quadrivalent
human papillomavirus vaccine: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. 2007; 56: 1-24.
6 Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER. Quadrivalent
human papillomavirus vaccine: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. 2007; 56: 1-24.
7 Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter
S, et al. Females United to Unilaterally Reduce Endo/Ectocervical Disease
(FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus
to prevent anogenital diseases. N Engl J Med. 2007; 356(19):1928-43.
8 The FUTURE II Study Group. Prophylactic efficacy of a quadrivalent
human papillomavirus (HPV) vaccine in women with virological evidence
of HPV infection. J Infect Dis. 2007; 196:1438-1446.
9 FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus
to prevent high-grade cervical lesions. N Engl J Med. 2007; 356(19):1915-27.
10 Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, et al.
Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity
of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and
18) L1 virus-like particle vaccine in male and female adolescents and young
adult women. Pediatrics. 2006; 118(5):2135-45.
12 Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM et al.
Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine
against infection with human papillomavirus types 16 and 18 in young women:
an interim analysis of a phase III double-blind, randomised controlled trial.
Lancet 2007;370(9596):1414.
13 National Institutes of Health (NIH). NIH Consensus Statement: Cervical
Cancer. 1996; 14:1-38.
14 Swan J, Breen N, Coates RJ, Rimer BK, Lee NC. Progress in cancer screening
practices in the United States: Results from the 2000 National Health Interview
Survey. Cancer, 2003; 1528-1540
15 Ho GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginal
papillomavirus infection as measured by repeated DNA testing in adolescent
and young women. N Engl J Med. 1998; 338(7):423-428.
16 Leyden WA, Manos MM, Geiger AM, Weinmann S, Mouchawar J, Bischoff K, et
al.. Cervical cancer in women with comprehensive health care access: Attributable
factors in the screening process. J Natl Cancer Inst. 2005;97(9):675-83.
18 Singh GK,
Miller BA, Hankey BF, Edwards BK. Persistent area socioeconomic disparities
in U.S. incidence of cervical cancer, mortality, stage, and survival, 1975-2000.
Cancer, 2004;101(5):1051-7.
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