The U.S. Food and Drug Administration recently approved a quadrivalent human papillomavirus (HPV) vaccine for females aged 9–26 years. The American College of Obstetricians and Gynecologists (ACOG) recommends the vaccination of females in this age group. The Advisory Committee on Immunization Practices has recommended that the vaccination routinely be given to girls when they are 11 or 12 years old. Although obstetrician–gynecologists are not likely to care for many girls in this initial vaccination target group, they are critical to the widespread use of the vaccine for females aged 13–26 years. Specific recommendations regarding the use of the quadrivalent HPV vaccine will be published in the September 2006 issue of Obstetrics & Gynecology. Because of the urgent nature of this information, excerpts of the recommendations are being posted online in advance of publication.

Recommendations

Vaccination of Girls, Adolescents, and Young Women

The ACOG Committee on Adolescent Health Care and the ACOG Working Group on Immunization recommend the vaccination of females aged 9–26 years against HPV. The Advisory Committee on Immunization Practices has recommended the initial vaccination target of females aged 11 or 12 years (1). Although obstetrician–gynecologists are not likely to care for many girls in this initial vaccination target group, they are critical to the widespread use of the vaccine for females aged 13–26 years. The American College of Obstetricians and Gynecologists has recommended that the first adolescent reproductive health care visit take place between ages 13 years and 15 years (2). Adolescents and young women aged 16–26 years who are in the vaccination age groups visit obstetrician–gynecologists for primary care, contraceptive or other gynecologic needs, or pregnancy-related services. These visits are a strategic time to discuss HPV and the potential benefit of the HPV vaccine and to offer vaccination to those who have not already received it. During a health care visit with a girl or woman in the age range for vaccination, an assessment of the patient’s HPV vaccine status should be conducted and documented in the patient record.

Cervical Cytology Screening

Current cervical cytology screening recommendations remain unchanged and should be followed regardless of vaccination status (2–6). Cervical cancer screening should begin approximately 3 years after the onset of vaginal intercourse or no later than age 21 years (5). After the first screening, annual cervical cytology screening should be conducted for women younger than 30 years (6). It must be emphasized that the currently approved quadrivalent vaccine protects against acquisition of HPV genotypes that account for only 70% of HPV-related cervical cancer and only 90% of genital warts cases (7). The vaccine is a preventive tool and is not a substitute for cancer screening.

Human Papillomavirus Testing

Testing for HPV is currently not recommended before vaccination. Testing for HPV DNA would not identify past HPV infections, only current HPV infections. Serologic assays for HPV are unreliable and currently not commercially available. Requiring any type of screening test would raise the cost of vaccination programs dramatically and reduce the cost-effectiveness of vaccination.

Vaccination of Sexually Active Women

Sexually active women can receive the quadrivalent HPV vaccine. Women with previous abnormal cervical cytology or genital warts also can receive the quadrivalent HPV vaccine. These patients should be counseled that the vaccine may be less effective in women who have been exposed to HPV before vaccination than in women who were HPV naive at the time of vaccination (8, 9). Women with previous HPV infection will benefit from protection against disease caused by the HPV vaccine genotypes with which they have not been infected. The need for annual cervical cytology screening should be emphasized.

Vaccination of Women With Previous Cervical Intraepithelial Neoplasia

There is concern that provision of the vaccination to women with previous cervical intraepithelial neoplasia may create a false sense of protection, potentially deterring patients from continuing their regular screening and management. The quadrivalent vaccine can be given to patients with previous cervical intraepithelial neoplasia, but practitioners need to emphasize that the benefits may be limited, and cervical cytology screening and corresponding management based on ACOG recommendations must continue.

Vaccination Is Not Treatment

The quadrivalent HPV vaccine is not intended to treat patients with cervical cytologic abnormalities or genital warts. Patients with these conditions should undergo the appropriate evaluation and treatment. It is important to note that many early cytologic abnormalities can be detected and managed conservatively given the significant rate of regression. This is especially true in adolescents and young women (4, 10).

Vaccination of Pregnant and Lactating Women

The quadrivalent HPV vaccine has been classified by the FDA as pregnancy category B. Although its use in pregnancy is not recommended, no teratogenic effects have been reported in animal studies. In clinical studies, the proportion of pregnancies with an adverse outcome was comparable in women who received the quadrivalent HPV vaccine and in women who received a placebo (8). The manufacturer’s pregnancy registry should be contacted if pregnancy is detected during the vaccination schedule. Completion of the series should be delayed until pregnancy is completed. It is not known whether vaccine antigens or antibodies found in the quadrivalent vaccine are excreted in human milk (8). Lactating women can receive the quadrivalent HPV vaccine because inactivated vaccines such as this vaccine do not affect the safety of breastfeeding for mothers or infants (11).

Vaccination of Immunosuppressed Patients

The presence of immunosuppression, like that experienced in patients with HIV infection, is not a contraindication to the quadrivalent HPV vaccine. However, the immune response may be smaller in the immunocompromised patient than in immunocompetent patients (8).

Vaccination of Women Older Than 26 Years and Males

Research regarding vaccination of women older than 26 years and males is currently under way. Data available are insufficient to make recommendations for these populations.

For additional information prior to the release of the September 2006 issue of Obstetrics & Gynecology, please refer to the following web sites:

Product approval information for GARDASIL www.fda.gov/cber/products/hpvmer060806.htm

FDA Office of Women's Health Fact Sheet—HPV
www.fda.gov/womens/getthefacts/hpv.html

HPV Vaccine Questions and Answers
www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm

The Society for Adolescent Medicine held a webcast on “HPV: Human Papillomavirus: What You Need to Know” in March 2006, which contained information on how to talk to parents about the vaccine for their children. It is available at: www.adolescenthealth.org/cme/program_hpv .

References

1.      Centers for Disease Control and Prevention. HPV vaccine [human papillomavirus (HPV) and the HPV vaccine]. Atlanta (GA): CDC. Available at: www.cdc.gov/nip/vaccine/hpv/ . Retrieved July 26, 2006.

2.      American College of Obstetricians and Gynecologists. Primary and preventive health care for female adolescents. In: Health care for adolescents. Washington, DC : ACOG; 2003. p. 1–24.

3.      Human papillomavirus. ACOG Practice Bulletin No. 61. American College of Obstetricians and Gynecologists. Obstet Gynecol 2005;105:905–18.

4.      Evaluation and management of abnormal cervical cytology and histology in the adolescent. ACOG Committee Opinion No. 330. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006:107:963–8.

5.      Cervical cancer screening in adolescents. ACOG Committee Opinion No. 300. American College of Obstetricians and Gynecologists. Obstet Gynecol 2004;104:885–9.

6.      Cervical cytology screening. ACOG Practice Bulletin No. 45. American College of Obstetricians and Gynecologists. Obstet Gynecol 2003;102:417–27.

7.      Bosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, et al. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst 1995;87:796–802.

8.      Prescribing information for GARDASIL. Whitehouse Station (NJ): Merck & Co., Inc.; 2006. Available at: www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf . Retrieved June 26, 2006.

9.      Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown DR, Wiley DJ, et al. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial [published erratum appears in Obstet Gynecol 006;107:1425]. Obstet Gynecol 2006;107:18–27.

10.  Moscicki AB, Shiboski S, Broering J, Powell K, Clayton L, Jay N, et al. The natural history of human papillomavirus infection as measured by repeated DNA testing in adolescent and young women. J Pediatr 1998;132:277–84.

11.  Atkinson WL, Pickering LK, Schwartz B, Weniger BG, Iskander JK, Watson JC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family
Physicians (AAFP). Centers for Disease Control and Prevention. MMWR Recomm Rep 2002;51(RR-2):1–35.