COMMITTEE OPINION

Number 704 • June 2017 (Replaces Committee Opinion Number 641, September 2015)

Committee on Adolescent Health Care

Immunization Expert Work Group
This Committee Opinion was developed by the Immunization Expert Work Group and the Committee on Adolescent Health Care,
with the assistance of Linda O’Neal Eckert, MD; and Anna-Barbara Moscicki, MD.
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Human Papillomavirus Vaccination

ABSTRACT: Human papillomavirus (HPV) is associated with anogenital cancer (including cervical, vaginal,
vulvar, penile, and anal), oropharyngeal cancer, and genital warts. The HPV vaccination significantly reduces the
incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only 41.9% of girls in
the recommended age group, and only 28.1% of males in the recommended age group have received all recom-
mended doses. Compared with many other countries, HPV vaccination rates in the United States are unacceptably
low. The U.S. Food and Drug Administration has approved three vaccines that are effective at preventing HPV
infection. These vaccines cover 2, 4, or 9 HPV serotypes, respectively. Safety data for all three HPV vaccines are
reassuring. The HPV vaccines are recommended for girls and boys aged 11–12 years and can be given to females
and males up to age 26 years. The Advisory Committee on Immunization Practices and the American College
of Obstetricians and Gynecologists recommend routine HPV vaccination for girls and boys at the target age of
11–12 years (but it may be given from the age of 9 years) as part of the adolescent immunization platform in order
to help reduce the incidence of anogenital cancer and genital warts associated with HPV infection. Obstetrician–
gynecologists and other health care providers should stress to parents and patients the benefits and safety of HPV
vaccination and offer HPV vaccines in their offices.

Recommendations and Conclusions • Obstetrician–gynecologists and other health care

The American College of Obstetricians and Gynecolo- providers can use well-women visits as an opportu-
gists (the College) makes the following recommendations nity to provide counseling to parents and encourage
and conclusions: them to speak to their children’s health care provid-
ers to request HPV vaccination at the targeted age
• It is crucial that obstetrician–gynecologists and other range of 11–12 years.
health care providers educate parents and patients
on the benefits and safety of human papillomavirus • The Centers for Disease Control and Prevention
(HPV) vaccination and offer HPV vaccines in their (CDC) and the College recommend routine HPV
offices. A health care provider’s recommendation to vaccination for females and males aged 9–26 years.
vaccinate is a strong influence in parents’ decision • The target age for HPV vaccination is 11–12 years for
making. girls and boys, but the HPV vaccine can be given to
• Obstetrician–gynecologists play a critical role in both genders through 26 years of age.
women’s care and should assess and vaccinate ado- • For girls and boys who receive their first dose of HPV
lescent girls and young women with HPV vaccine vaccine before 15 years of age, only two doses are
during the catch-up period (ages 13–26 years). needed. The timing of the two doses is 0 (baseline)
• Obstetrician–gynecologists and other health care and 6–12 months. If the interval between the two
providers play a significant role and should educate doses is less than 5 months, a third dose is recom-
parents in their decision making regarding vaccina- mended. If females or males receive their first dose at
tions for male and female children. 15 years of age or older, three doses are needed and
 given at 0 (baseline), 1–2 months after the first dose, HPV vaccination may decrease the incidence of oropha-
and 6 months after the first dose. ryngeal cancer as well as the maternal transmittal of HPV
• Testing for HPV DNA is not recommended before to infants. Human papillomavirus in infants may result
vaccination. Vaccination is recommended even if the in recurrent laryngeal papillomatosis, although definitive
patient is tested for HPV DNA and the results are prevention trials have not been completed for these two
positive. disease endpoints (9). In the United States, the prevalence
of vaccine-type HPV decreased 56% among females
• Even if a patient previously has had an abnormal
aged 14–19 years between 2006 (when the quadrivalent
Pap test or history of genital warts, vaccination is still
HPV vaccine was introduced) and 2010 (10). Despite the
recommended.
benefits of HPV vaccines, only 41.9% of females in the
• Obstetrician–gynecologists and other health care recommended age group, and only 28.1% of males in the
providers should assess patients for severe allergies, recommended age group have received all recommended
including but not limited to an allergy to yeast or doses (11). Compared with many other countries, HPV
prior HPV vaccine dose. An individual with a mod- vaccination rates in the United States are unacceptably
erate or severe febrile illness should wait until the low (11).
illness improves before receiving a vaccine.
• Although HPV vaccination in pregnancy is not Human Papillomavirus Vaccines
recommended, neither is routine pregnancy test- The U.S. Food and Drug Administration (FDA) has
ing before vaccination. If the HPV vaccine series approved three vaccines that are effective at preventing
was interrupted for pregnancy, the series should be HPV infection. These vaccines cover 2, 4, or 9 HPV sero-
resumed postpartum with the next dose. types, respectively. The HPV vaccine is recommended
• HPV vaccines can and should be given to breast- for girls and boys aged 11–12 years and can be given
feeding women 26 years and younger who have not to females and males up to age 26 years. For girls and
previously been vaccinated. boys who receive their first dose of HPV vaccine before
• Obstetrician–gynecologists and other health care 15 years of age, only two doses are needed. The timing
providers should counsel patients to expect mild of the two doses is 0 (baseline) and 6–12 months. If the
local discomfort after the vaccination and that such interval between the two doses is less than 5 months, a
discomfort is not a cause for concern. Adolescents third dose is recommended (12). An interval greater than
should be observed for at least 15 minutes after vac- 12 months is not recommended in order to ensure both
cination because they are at higher risk of fainting. doses are given before the onset of sexual activity. If
females or males receive their first dose at 15 years of age
Human papillomavirus (HPV) is associated with ano-
or older, three doses are needed and given at 0 (baseline),
genital cancer (including cervical, vaginal, vulvar, penile,
and anal), oropharyngeal cancer, and genital warts. Of 1–2 months after the first dose, and 6 months after the
the more than 150 HPV genotypes, 13 genotypes have first dose (12).
been shown to cause cervical cancer (1). Most cases of The durability of the immune response (ie, how long
HPV-associated cancer are caused by HPV genotypes 16 protection lasts) is being monitored in long-term studies,
and 18 (2–5). In the United States, HPV genotypes 16 and and currently there is no indication for a booster vaccine
18 account for 66% of cases of cervical cancer, and HPV (13). The vaccine series does not need to be restarted in
genotypes 31, 33, 45, 52, and 58 account for an additional the case of a delay in administration of the second or
15% of cases of cervical cancer (5). For cervical intraepi- third dose.
thelial neoplasia 2+, 50–60% of cases are caused by HPV Although obstetrician–gynecologists are not likely
genotypes 16 and 18, and 25% of cases are caused by HPV to care for many patients in the initial HPV vac-
genotypes 31, 33, 45, 52, and 58 (6). Approximately 90% cination target group, they have the opportunity to
of cases of genital warts are caused by HPV genotypes 6 educate women about the importance of vaccinating
and 11 (7). their children at the recommended age. Obstetrician–
Despite cervical cytology screening in the United gynecologists and other health care providers play a
States, each year cervical cancer is diagnosed in more significant role and should educate parents in their
than 13,000 women and nearly 4,000 die from the disease decision making regarding vaccinations for male and
(8). Most of these cases of cancer occur because of a lack female children. Furthermore, obstetrician–gynecologists
of adequate screening. Human papillomavirus-associated play a critical role in women’s care and should assess
cancer also occurs in males. The average number of and vaccinate adolescent girls and young women with
anogenital or oropharyngeal cancer in males per year the HPV vaccine during the catch-up period (ages
is 15,793, and 10,200 (65%) of these are associated with 13–26 years). Human papillomavirus vaccination is
HPV 16 or HPV 18 (3). not associated with an earlier onset of sexual activ-
The HPV vaccine significantly reduces the incidence ity (14) or increased incidence of sexually transmitted
of anogenital cancer and genital warts. Additionally, infections (15).

2 Committee Opinion No. 704

Timing of Vaccination HPV vaccine among approximately 14,000 females aged
The Advisory Committee on Immunization Practices 16–26 years, the 9-valent HPV vaccine had high effi-
and the College recommend routine HPV vaccination for cacy for prevention of cervical intraepithelial neoplasia
girls and boys at the target age of 11–12 years (but it may 2+, vulvar intraepithelial neoplasia 2 or 3, and vaginal
be given from the age of 9 years) as part of the adolescent intraepithelial neoplasia 2 or 3 due to HPV genotypes 31,
immunization platform in order to help reduce the inci- 33, 45, 52, and 58 (see Table 1) (20). The antibody titer
dence of anogenital cancer and genital warts associated against HPV genotypes 6, 11, 16, and 18 was not reduced
with HPV infection. Bivalent, quadrivalent, and 9-valent with the addition of the other five HPV genotypes (20).
vaccines are approved for females aged 9–26 years and Revaccination with the 9-valent HPV vaccine in
individuals who previously completed the three-dose
quadrivalent and 9-valent vaccines are approved for
series with the quadrivalent HPV vaccine or the bivalent
males aged 9–26 years. Recently, the bivalent vaccine
HPV vaccine currently is not a routine recommendation.
has been withdrawn from the U.S. market. The 9-valent
If obstetrician–gynecologists or other health care provid-
vaccine, which covers five additional cancer-related HPV
ers do not know or do not have the same HPV vaccine
serotypes will soon replace the quadrivalent vaccine.
product previously administered, or are in settings that
Studies show that two doses of HPV vaccine given
are transitioning to the 9-valent HPV vaccine, any avail-
6 months apart in individuals aged 9–14 years resulted
able HPV vaccine product may be used to continue or
in antibody titers equal to those in individuals aged
complete the series for females for protection against
15–26 years who were given three doses. Hence, only two
HPV genotypes 16 and 18; the 9-valent HPV vaccine or
doses, 6–12 months apart, are needed if HPV vaccination
the quadrivalent HPV vaccine may be used to continue or
is initiated before 15 years of age in boys and girls (11, complete the series for males (20).
12). The 6-month interval between these two doses is
critical for ensuring adequate immune titers and durabil- Safety
ity of protection. If the interval between the two doses Safety data for all three HPV vaccines are reassuring.
is less than 5 months, a third dose is recommended. In According to the Vaccine Adverse Events Reporting
addition to the ability to use two doses instead of three System, more than 60 million doses of HPV vaccine have
doses, earlier vaccination also is preferred because HPV been distributed since 2006, and there are no data to sug-
vaccines are most effective when given before prior expo- gest that there are any severe adverse effects or adverse
sure and infection with HPV, which coincide with the reactions linked to vaccination (21). The 9-valent and
onset of sexual activity. Statistics show that one in three quadrivalent vaccines had similar safety profiles, except
ninth graders and two in three 12th graders have engaged that the 9-valent HPV vaccine had a higher rate of injec-
in sexual intercourse (15, 16). In Sweden, vaccine effec- tion site swelling and erythema than the quadrivalent
tiveness in preventing genital warts was 93% among girls HPV vaccine, and the rate increased after each successive
vaccinated between 10 years and 13 years of age com- dose of the 9-valent HPV vaccine (20). Obstetrician–
pared with 48% and 21% if vaccinated at ages 20–22 years gynecologists and other health care providers should
and 23–26 years, respectively (17). All of these findings counsel patients to expect mild local discomfort after the
underscore the importance of vaccination at the target vaccination and that such discomfort is not a cause for
age (11–12 years), which is before the onset of potential concern. Available data demonstrate no safety concerns
exposure in the vast majority. in individuals who were vaccinated with the 9-valent
Vaccination is recommended regardless of sexual HPV vaccine after having been vaccinated with the quad-
activity or prior exposure to HPV. Although the vaccine rivalent HPV vaccine (22, 23). Anyone who has ever had a
may be less effective in previously infected individu- life-threatening allergic reaction to any component of the
als, it is expected that some benefit will be experienced HPV vaccine, or to a previous dose of the HPV vaccine,
because prior exposure to all nine vaccine types is highly should not get the vaccine. Obstetrician–gynecologists
unlikely (18, 19). Vaccination is recommended even if the and other health care providers should assess patients for
patient is tested for HPV DNA and the results are posi- severe allergies, including but not limited to an allergy
tive. Testing for HPV DNA is not recommended before to yeast or prior HPV vaccine dose. An individual with
vaccination. a moderate or severe febrile illness should wait until the
illness improves before receiving a vaccine.
9-valent Human Papillomavirus
Vaccine Considerations for Special
The 9-valent HPV vaccine was licensed by the U.S. Food Populations
and Drug Administration in December 2014. The Advis- Although HPV vaccination in pregnancy is not recom-
ory Committee on Immunization Practices has recom- mended, neither is routine pregnancy testing before vac-
mended similar schedules as those for quadrivalent cination. Available safety data regarding the inadvertent
vaccine. In a phase III efficacy trial that made a compari- administration of the vaccine during pregnancy are reas-
son of the 9-valent HPV vaccine with the quadrivalent suring (24, 25). Patients and obstetrician–gynecologists

Committee Opinion No. 704 3

Table 1. Use and Efficacy of the Bivalent, Quadrivalent, and 9-valent Human Papillomavirus Vaccines ^
Vaccine HPV Types Disease Reduction Efficacy*

Bivalent 16 and 18 HPV genotypes 16- and 18-related HPV disease related to genotypes 16
cervical cancer, CIN 1, CIN 2/3, and and 18; 98.1%†, ‡
adenocarcinoma in situ
Quadrivalent 6, 11, 16, and 18 HPV genotypes 6, 11, 16, and 18-related HPV disease related to genotypes 6, 11,
cervical, vulvar, and vaginal cancer; 16, and 18; up to 100%§, ||
CIN 1; CIN 2/3; adenocarcinoma in situ; External genital disease in men; 90.4%||
VIN 2/3; and vaginal intraepithelial
neoplasia 2/3 in females
Penile intraepithelial neoplasia 1/2/3 and
penile cancer in males
Warts, anal intraepithelial neoplasia,
and anal cancer in males and females
9-valent 6, 11, 16, 18, 31, 33, HPV genotypes 6, 11, 16, 18, 31, 33, 45, 52, HPV disease related to genotypes 6, 11,
45, 52, and 58 and 58-related cervical, vulvar, and vaginal 16, 18; greater than 99%
cancer; CIN 2/3; adenocarcinoma in situ; HPV related to genotypes 31, 33, 45, 52,
VIN 2/3; and vaginal intraepithelial neoplasia and 58; 96.7%¶
2/3 in females
Penile intraepithelial neoplasia 1/2/3 and
penile cancer in males¶
Warts, anal intraepithelial neoplasia, and anal
cancer in males and females

Abbreviations: CIN, cervical intraepithelial cancer; HPV, human papillomavirus; VIN, vulvar intraepithelial neoplasia.
*Efficacy rates based recipient being naive to the vaccine HPV genotypes at the time of vaccination.
†
Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection
and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. HPV PATRICIA Study Group [published erratum
appears in Lancet 2010;376:1054]. Lancet 2009;374:301–14.
‡
Donovan B, Franklin N, Guy R, Grulich AE, Regan DG, Ali H, et al. Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of nation-
al sentinel surveillance data. Lancet Infect Dis 2011;11:39–44.
§
Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated
genital diseases in young women. J Natl Cancer Inst 2010;102:325–39.
||
Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, et al. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males [pub-
lished erratum appears in N Engl J Med 2011;364:1481]. N Engl J Med 2011;364:401–11.
¶
Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations
of the Advisory Committee on Immunization Practices. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2015;64:300–4.

or other health care providers are encouraged to register response may be less robust in the immunocompromised
women exposed to the 9-valent HPV vaccine around patient (26). The three-dose regimen is recommended for
the time the pregnancy began or during pregnancy by immunosuppressed men and women.
contacting the manufacturer (www.merckpregnancyreg Human papillomavirus vaccines are not currently
istries.com/gardasil9.html). Pregnancy registries for the licensed in the United States for women older than
quadrivalent HPV vaccine and bivalent HPV vaccine 26 years. Off-label use may be indicated on a case-by-
have been closed. If a vaccine series is started and a case basis (27).
patient then becomes pregnant, completion of the vac-
cine series should be delayed until that pregnancy is com- Patient Education and Vaccination
pleted. Lactating women can receive any HPV vaccine Efforts
because inactivated vaccines like HPV do not affect the High rates of HPV vaccination will reduce the burden
safety of breastfeeding for these women or their infants of HPV-related disease in the United States. Current
(21). vaccination rates are unacceptably low. Studies have
The presence of immunosuppression, like that expe- shown that physicians’ recommendations play a crucial
rienced in patients with human immunodeficiency virus role in the acceptance of HPV vaccination by patients
(HIV) infection or organ transplantation, is not a con- and parents of patients (28). Obstetrician–gynecologists
traindication to HPV vaccination. However, the immune and other health care providers should stress to parents

4 Committee Opinion No. 704

and patients the benefits and safety of HPV vaccination on Immunization Practices (ACIP).  Centers for Disease
and offer HPV vaccines in their offices. Obstetrician– Control and Prevention (CDC) [published erratum appears
gynecologists play a critical role and should assess and in MMWR Morb Mortal Wkly Rep 2010;59:1184]. MMWR
vaccinate adolescent girls and young women during the Morb Mortal Wkly Rep 2010;59:626–9.  [PubMed] [Full
catch-up period (ages 13–26 years). Text] ^
According to the Centers for Disease Control and 8. American Cancer Society. Cancer facts & figures 2017.
Prevention, if health care providers increase HPV vac- Atlanta (GA): ACS; 2017. Available at: https://www.cancer.
cination rates in eligible recipients to 80%, it is estimated org/content/dam/cancer-org/research/cancer-facts-and-
that an additional 53,000 cases of cervical cancer could statistics/annual-cancer-facts-and-figures/2017/cancer-
facts-and-figures-2017.pdf. Retrieved February 22, 2017. ^
be prevented during the lifetime of those younger than
12 years (29). Furthermore, for every year that the vacci- 9. Wierzbicka M, Jozefiak A, Jackowska J, Szydlowski J,
nation rate does not increase, an additional 4,400 women Gozdzicka-Jozefiak A. HPV vaccination in head and neck
will develop cervical cancer. HPV-related pathologies. Otolaryngol Pol 2014;68:157–73.
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For More Information 10. Markowitz LE, Hariri S, Lin C, Dunne EF, Steinau M,
The American College of Obstetricians and Gynecologists McQuillan G, et al. Reduction in human papillomavirus
has identified additional resources on topics related to (HPV) prevalence among young women following HPV
vaccine introduction in the United States, National Health
this document that may be helpful for ob-gyns, other
and Nutrition Examination Surveys, 2003–2010. J Infect
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resources at: www.acog.org/More-Info/HPV.
These resources are for information only and are not 11. Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD,
meant to be comprehensive. Referral to these resources Curtis CR, MacNeil J, et al. National, regional, state, and
selected local area vaccination coverage among adolescents
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ISSN 1074-861X
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The American College of Obstetricians and Gynecologists
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6 Committee Opinion No. 704