The American College of

Obstetricians and Gynecologists

WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 588 • March 2014 (Replaces Committee Opinion Number 467, September 2010)

Committee on Adolescent Health Care

This Committee Opinion was developed with the assistance of the Immunization Expert Work Group. The document reflects emerging
clinical and scientific advances as of the date issued and is subject to change. This information should not be construed as dictating an
exclusive course of treatment or procedure to be followed.

Human Papillomavirus Vaccination

ABSTRACT: The Advisory Committee on Immunization Practices of the Centers for Disease Control and
Prevention recommends that human papillomavirus (HPV) vaccination routinely be targeted to females and males
aged 11 years or 12 years as part of the adolescent immunization platform to help reduce the incidence of ano-
genital cancers and genital warts associated with HPV infection. The quadrivalent HPV vaccine is approved for
use in males and females, whereas the bivalent HPV vaccine is approved for use only in females. For those not
vaccinated at the target age, catch-up vaccination is recommended up to age 26 years. The American College of
Obstetricians and Gynecologists endorses these recommendations. Although obstetrician–gynecologists are not
likely to care for many patients in the initial HPV vaccination target group, they have the opportunity to educate
mothers about the importance of vaccinating their children at the recommended age and are critical to vaccinating
adolescent girls and young women during the catch-up period. Obstetrician–gynecologists should advise patients
and parents that HPV vaccines are most effective in preventing genital cancers when administered before the
onset of sexual activity. However, sexually active individuals can receive some benefit from the vaccination
because exposure to all HPV types prevented by the vaccines is unlikely in persons aged 13 years through 26
years. Although HPV vaccination in pregnancy is not recommended, neither is routine pregnancy testing before
vaccination. Lactating women can receive either HPV vaccine. The need for ongoing cervical cytology screening
should be emphasized in all women aged 21 years and older, even those who received HPV vaccination before
the onset of sexual activity.

Human papillomavirus (HPV) is a group of more than require evaluation (4, 5). Although the implementation
120 different viruses. Infection with HPV is associated of cervical cytology screening programs and treatment
with the development of anogenital cancers (including of precancerous lesions has led to a decrease in deaths
cervical, vaginal, vulvar, and anal), oropharyngeal cancer, from cervical cancer in the United States, such deaths
and genital warts. Approximately 40 HPV genotypes are still occur. Approximately one half of all cases of cervical
primarily sexually transmitted from person to person (eg, cancer are found in women who have never had a Pap test,
genital–genital contact, oral–genital contact, and sexual and another 10% occur in patients who have not had one
intercourse) and infect the oral, anal, or genital areas of within the past 5 years (6). Both ongoing cervical cytology
men and women. However, only 13 genotypes have been screening and HPV vaccination are needed to help reduce
shown to cause cervical cancer (1). Approximately 70% of these deaths.
all cases of cervical cancer are caused by HPV genotypes Human papillomavirus vaccination can also help
16 and 18, and 90% of cases of genital warts are caused by reduce the incidence of other anogenital cancers and
HPV genotypes 6 and 11 (2). genital warts and may decrease the incidence of oropha-
Each year in the United States, cervical cancer is ryngeal cancer. Each year in the United States, HPV is
diagnosed in more than 12,000 women, and nearly 4,000 believed to cause approximately 2,600 cases of vulvar and
die from the disease (3). In addition, there are more than vaginal cancer, 4,300 cases of anal cancer, 360,000 cases of
1 million cases of abnormal cytology screening results that genital warts, and more than 8,400 cases of oropharyngeal

712 VOL. 123, NO. 3, MARCH 2014 OBSTETRICS & GYNECOLOGY

cancer (7). Approximately 35% of all cases of anal cancer effectiveness in preventing genital warts was 93% among
and 80% of all cases of oropharyngeal cancer are in men girls vaccinated between ages 10 years and 13 years com-
(7). pared with 48% and 21% if vaccinated at ages 20–22 years
and 23–26 years, respectively (15). Data from the United
Human Papillomavirus Vaccines States show that 1 month after the completion of HPV
The U.S. Food and Drug Administration (FDA) has vaccination, girls aged 10–14 years generally have higher
approved two vaccines shown to be effective at prevent- antibody levels than young women aged 15–26 years and
ing HPV infection. The quadrivalent HPV vaccine is indi- retain these higher levels for several years (16, 17). All of
cated to prevent cancers and intraepithelial neoplasias these findings underscore the importance of vaccination
of the cervix, anus, vulva, and vagina and genital warts during the target age or before the onset of sexual activity.
associated with HPV genotypes 6, 11, 16, and 18 (8). The In the United States, the prevalence of vaccine-type
FDA has approved administration of the quadrivalent HPV has decreased 56% among females aged 14–19 years
three-dose vaccine to females and males aged 9–26 years. since the quadrivalent vaccine was introduced in 2006
The bivalent three-dose HPV vaccine has FDA approval (18). The observed decrease in vaccine-associated HPV
for administration to females aged 9–25 years for the prevalence is likely due to the protection induced by a
prevention of cervical cancer, cervical intraepithelial neo- single vaccine dose, at least in the short term. According
plasia (CIN) 2 or worse and adenocarcinoma in situ, and to the Centers for Disease Control and Prevention
CIN 1 caused by oncogenic HPV genotypes 16 and 18 (9). (CDC), slightly more than 50% of 13–17-year-olds in the
United States have received at least one vaccine dose, and
Efficacy only 33% have received all three doses (19). Recent data
Studies of the quadrivalent HPV vaccine have shown that demonstrate that individuals who received two doses of
among participants who were naive to the vaccine geno- the quadrivalent vaccine at 0 and 6 months had similar
types and who followed protocol, the vaccine was nearly antibody responses within 6 months as those receiving
100% effective in preventing CIN 2, CIN 3, and condy- three doses (16). However, at 24–36 months, those who
lomatous vulvar disease related to the HPV genotypes received two doses showed a lower level of antibody
covered by the vaccine (8). Similarly, clinical trials in men response than those who received three doses (16). Thus,
showed an efficacy of 90.4% in preventing external geni- reduced dose schedules are not currently recommended.
tal lesions associated with the HPV genotypes covered The need for booster doses remains to be demon-
by the vaccine (10). In a substudy of men who have sex strated but is unlikely (13). The current three-dose vac-
with men, the quadrivalent vaccine was 77.5% effective in cine series is designed to maximize the primary immune
preventing anal intraepithelial neoplasia related to HPV response and enhance long-term protection. The dura-
genotypes 6, 11, 16, and 18, leading to FDA approval of bility of the immune response (ie, how long protection
the quadrivalent vaccine for the prevention of anal cancer lasts) is being monitored in various long-term studies,
and associated precancerous lesions that are caused by and there is currently no indication for a booster vaccine.
these HPV genotypes (11). Results of studies of the biva-
lent HPV vaccine indicate that it offers protection similar Safety
to the quadrivalent vaccine against CIN 2 and CIN 3 in Safety data for both HPV vaccines are reassuring.
adolescent and young women who are naive to the vac- According to the Vaccine Adverse Events Reporting
cine’s HPV genotypes 16 and 18 (12, 13). The bivalent System, more than 57 million doses of HPV vaccine have
vaccine does not protect against lower genital tract con- been distributed, and there are no data to suggest that
dyloma caused by low-risk HPV genotypes 6 and 11 (ie, there are any severe side effects or adverse reactions linked
associated with genital warts). There is evidence that each to vaccination (20). Ongoing surveillance of HPV vaccine
vaccine provides some minor degree of cross-protection side effects—which include syncope, nausea, headache,
against other nonvaccine HPV genotypes that are associ- dizziness, and local pain and redness—shows no new,
ated with disease (14). unexpected adverse reactions (20). Although there was an
To be maximally effective, vaccination with either observed increase of venous thromboembolism in those
vaccine should be given during the target ages (11 years vaccinated, on review it was determined that this finding
and 12 years) or before the onset of sexual activity. If the was not statistically significant because all five patients had
vaccine is given after the onset of sexual activity, patients prior known risks of venous thromboembolism (21). The
may have already been infected with HPV. Data from CDC continues to consider HPV vaccines safe.
Australia, where coverage is more than 75% in the target
age group (females only), showed that the diagnosis of Vaccination of Specific Populations
genital warts in females decreased by 73% within 3 years The following are recommendations for HPV vaccination
of vaccine introduction (13). There also was a significant of specific groups. Testing for HPV DNA is not required
decrease in the diagnosis of genital warts in heterosexual or recommended before vaccination in any group. If
men, suggesting herd immunity. In Sweden, data that the patient is tested for HPV DNA and the results are
linked multiple population registers showed that vaccine positive, vaccination is still recommended because the

VOL. 123, NO. 3, MARCH 2014 Committee Opinion Human Papillomavirus Vaccination 713
chance that the patient has been exposed to all vaccine- warts associated with HPV infection. The quadrivalent
preventable HPV genotypes is low. HPV vaccine is approved for use in males and females,
In all states, minors are allowed to give consent for whereas the bivalent HPV vaccine is approved for use
the diagnosis and treatment of sexually transmitted infec- only in females. Depending on the circumstances, the
tions. However, many of the laws that authorize them to vaccine can be given to individuals as young as 9 years.
provide such consent may only permit it after they have For those not vaccinated at the target age, catch-up vac-
reached a specific age. Furthermore, these laws do not cination is recommended up to age 26 years (see Box 1)
mention vaccinations (22). Clinicians should be familiar (2). Once the vaccination series has begun, there is no
with state and local statutes regarding the rights of minors evidence to suggest that the series needs to be restarted if
to consent to health care services and the federal and state there is a delay in administration of subsequent vaccine
laws that affect confidentiality. doses.
The American College of Obstetricians and Gyne-
Girls and Boys, Adolescents, and Young cologists endorses these recommendations. During a
Women and Men health care visit with a girl, adolescent, or a young woman
The Advisory Committee on Immunization Practices of in the age range for vaccination, obstetrician–gynecolo-
the CDC recommends that HPV vaccination routinely be gists should assess the patient’s HPV vaccine status, dis-
targeted to females and males aged 11 years or 12 years cuss HPV and the potential benefit of HPV vaccination,
as part of the adolescent immunization platform to help offer vaccination as needed, and document this informa-
reduce the incidence of anogenital cancer and genital tion in the patient’s medical record.

Box 1. Key Information Regarding the Bivalent and

Quadrivalent Human Papillomavirus Vaccines* ^

Dosage
Administered intramuscularly as three separate 0.5-mL doses based on the following schedule:
1. First dose: at elected date
2. Second dose: 1–2 months after the first dose
3. Third dose: 6 months after the first dose
Minimum interval between first and second dose is 4 weeks, between second and third dose is 12 weeks, and between first and
third dose is 24 weeks. If the vaccine schedule is interrupted, the series does not need to be restarted, regardless of the length
of time between doses. Whenever possible, the same vaccine product should be used for all doses in the series.
Recommended Age
• Target population: females and males† aged 11 years or 12 years (can be started as early as age 9 years)
• Females and males† who did not receive the vaccination at the target age can be vaccinated from age 13 years through 26
years
Contraindications
Individuals who develop symptoms indicative of hypersensitivity to the active substances or to any of the components of either
vaccine after receiving a dose of vaccine should not receive further doses of the product. Safety and effectiveness of the two
formulations have not been established in pregnant women. Any exposure to it during pregnancy should be reported to the
manufacturer by calling 1-877-888-4231 for the quadrivalent vaccine and 1-888-452-9622 for the bivalent vaccine.
Precautions
As with any vaccine, vaccination may not protect all vaccine recipients. Neither vaccine is intended to be used for treatment
of active disease (ie, genital warts, cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or
vaginal intraepithelial neoplasia). Human papillomavirus (HPV) vaccines can be administered simultaneously or at any time
before or after a different inactivated or live vaccine administration. Because vaccinated individuals may develop syncope,
sometimes resulting in falling with injury, health care providers should consider observing patients for 15 minutes after vaccine
administration.
Storage
Both formulations should be refrigerated at 2–8°C (36–46°F), should not be frozen, and should be protected from light.
Vaccine Adverse Event Reporting
To report an adverse event associated with administration, go to http://vaers.hhs.gov.
(continued)

714 Committee Opinion Human Papillomavirus Vaccination OBSTETRICS & GYNECOLOGY

 Box 1. Key Information Regarding the Bivalent and
Quadrivalent Human Papillomavirus Vaccines* (continued)

Advisory Committee on Immunization Practices Recommendations

For current recommendations by the Advisory Committee on Immunization Practices, go to http://www.cdc.gov/vaccines/recs/
acip/default.htm.
Current Procedural Terminology Code‡
The American Medical Association has established a Current Procedural Terminology code of 90649 for quadrivalent HPV
vaccination and 90650 for bivalent HPV vaccine.
*Note that the U.S. Food and Drug Administration labeling for the bivalent vaccine indicates it is for use in females aged 9–25 years. In addi-
tion, the U.S. Food and Drug Administration approved dosage intervals for the quadrivalent and bivalent vaccines to be 0 months, 2 months,
and 6 months and 0 months, 1 month, and 6 months, respectively.
†
The U.S. Food and Drug Administration has approved the quadrivalent vaccine for use in males aged 9–26 years for the prevention of genital
warts.
‡
Current Procedural Terminology (CPT) copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of
the American Medical Association.
Data from Centers for Disease Control and Prevention. FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use
in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP). MMWR Morb
Mortal Wkly Rep 2010;59:626–9.

Sexually Active Adolescents and Young Women vaccination. Currently, there are few data on HPV vac-
Sexually active adolescents and young women can receive cine administration in pregnancy; however, the available
either the quadrivalent or bivalent HPV vaccine. These safety data regarding the inadvertent administration
patients should be counseled that the vaccine may be less of the vaccine during pregnancy are reassuring (25,
effective in individuals who have been exposed to HPV 26). In clinical studies, the proportion of pregnancies
before vaccination than in individuals who were HPV with adverse outcomes was comparable in women who
naive at the time of vaccination (8, 12). However, sexually received the HPV vaccine and in women who received
active individuals can receive some benefit from the vac- a placebo (9, 27). However, it is wise to remind patients
cination because exposure to all HPV types prevented by to use contraception during the period when they are
the vaccines is unlikely in persons aged 13 years through receiving the vaccination series. The manufacturer should
26 years. The need for ongoing cervical cytology screen- be contacted if pregnancy is detected during the vaccina-
ing should be emphasized in all women aged 21 years and tion schedule (see Box 1). Completion of the vaccine
older, even those vaccinated before the onset of sexual series should be delayed until pregnancy is completed.
activity. Lactating women can receive either HPV vaccine because
inactivated vaccines, such as these vaccines, do not affect
Adolescents and Young Women With Previous the safety of breastfeeding for mothers or infants (28).
Cervical Intraepithelial Neoplasia or Genital
Warts Immunosuppressed Patients
The HPV vaccines can be given to patients with previ- The presence of immunosuppression, like that experi-
ous CIN or genital warts. Health care providers need to enced in patients with HIV infection or organ transplan-
emphasize that the benefits may be limited and cervi- tation, is not a contraindication to HPV vaccination.
cal cytology screening and corresponding management However, the immune response may be less robust in the
based on College recommendations must continue. The immunocompromised patient (29).
HPV vaccines are not intended to be treatment for cervi- Women Older Than 26 Years
cal cytologic abnormalities, genital warts, or a positive
Human papillomavirus vaccines are not currently licensed
HPV DNA test result. Patients with these conditions
should undergo the appropriate evaluation and treat- in the United States for women older than 26 years. Off-
ment (23, 24). label use may be indicated on a case-by-case basis because
vaccination may provide some marginal benefit (16).
Pregnant and Lactating Women
Both the quadrivalent and bivalent HPV vaccines have Patient Education and Vaccination
been classified by the FDA as pregnancy category B. Efforts
Although HPV vaccination in pregnancy is not recom- Obstetrician–gynecologists are encouraged to discuss
mended, neither is routine pregnancy testing before the benefits of HPV vaccination with patients aged

VOL. 123, NO. 3, MARCH 2014 Committee Opinion Human Papillomavirus Vaccination 715
11–26 years and to offer initial vaccination and catch-up Pamphlet AP073. Washington, DC: American College of
vaccination as needed. Although obstetrician–gynecolo- Obstetricians and Gynecologists; 2013.
gists are not likely to care for many patients in the initial American College of Obstetricians and Gynecologists.
HPV vaccination target group, they have the opportunity Infeccion del virus del papiloma humano [Spanish]. Patient
to educate mothers about the importance of vaccinating Education Pamphlet SP073. Washington, DC: American
their children at the recommended age and are critical College of Obstetricians and Gynecologists; 2013.
to vaccinating adolescent girls and young women during
American College of Obstetricians and Gynecologists.
the catch-up period. It is important for health care pro-
Human papillomavirus. In: Tool kit for teen care. 2nd ed.
viders to educate patients and parents of children in the
Washington, DC: ACOG; 2009. 
target age range for HPV vaccination about HPV-related
disease and be prepared to respond to questions regard- American College of Obstetricians and Gynecologists.
ing HPV vaccination, including its benefits, limitations, Immunization for women. Available at: http://www.
and safety, as discussed earlier. Studies have shown that immunizationforwomen.org. Retrieved January 10, 2013.
physicians’ recommendations play a crucial role in the Screening for cervical cancer. Practice Bulletin No. 131.
acceptance of HPV vaccination by patients and parents American College of Obstetricians and Gynecologists.
of patients (30). Many parents think that HPV vaccina- Obstet Gynecol 2012;120:1222–38.
tion is not needed and are concerned about safety and
adverse reactions (31). Obstetrician–gynecologists should Other Resources
advise patients and parents that HPV vaccines are most The following list is for information purposes only. Referral to these sources
effective in preventing genital cancers when administered and web sites does not imply the endorsement of the American College of
before the onset of sexual activity, although HPV can be Obstetricians and Gynecologists. This list is not meant to be comprehensive.
The exclusion of a source or web site does not reflect the quality of that
contracted without sexual activity. In addition, patients source or web site. Please note that web sites are subject to change without
and parents can be counseled that HPV vaccines are safe notice.
and associated with few side effects, none of which are
severe. An additional concern among some parents is that American Cancer Society 
HPV vaccination may cause an increase in sexual activity 250 Williams Street, NW
among adolescents. However, health care providers can Atlanta, GA 30303
reassure parents that this is not the case. A study of 1,398 1-800-227-2345
girls aged 11–12 years found that HPV vaccination was http://www.cancer.org
not associated with increased sexual activity outcomes American Sexual Health Association
that included pregnancy, sexually transmitted infection PO Box 13827
testing or diagnosis, or contraceptive counseling (32). Research Triangle Park, NC 27709
According to the CDC, if health care providers (919) 361-8400
increase HPV vaccination coverage to 80%, it is estimated http://www.ashastd.org
that an additional 53,000 cases of cervical cancer could be American Society for Colposcopy and Cervical
prevented during the lifetime of those younger than 12 Pathology
years (19). Furthermore, for every year that coverage does 1530 Tilco Drive, Suite C
not increase, an additional 4,400 women will develop Frederick, MD 21704
cervical cancer. These data highlight the overwhelming (301) 733-3640
importance of HPV vaccination efforts, including discus- 1-800-787-7227
sions with patients and parents of children and adoles- http://www.asccp.org
cents about the benefit of HPV immunization for cancer Center for Young Women’s Health
prevention (19). 333 Longwood Avenue, 5th floor
Boston, MA 02115 
American College of Obstetricians and (617) 355-2994 
Gynecologists’ Resources http://www.youngwomenshealth.org
American College of Obstetricians and Gynecologists. Centers for Disease Control and Prevention
Cómo prevenir las enfermedades de transmisión sexual 1600 Clifton Road
[Spanish]. Patient Education Pamphlet SP009. Wash- Atlanta, GA 30333
ington, DC: American College of Obstetricians and 1-800-CDC-INFO (1-800-232-4636)
Gynecologists; 2013. http://www.cdc.gov
American College of Obstetricians and Gynecologists. Planned Parenthood Federation of America
How to prevent sexually transmitted diseases. Patient 434 West 33rd Street
Education Pamphlet AP009. Washington, DC: American New York, NY 10001
College of Obstetricians and Gynecologists; 2013. (212) 541-7800
American College of Obstetricians and Gynecologists. 1-800-230-7526
Human papillomavirus infection. Patient Education http://www.plannedparenthood.org

716 Committee Opinion Human Papillomavirus Vaccination OBSTETRICS & GYNECOLOGY

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