Medical Institute's Statement on HPV Vaccine
A quadrivalent HPV (human papillomavirus) vaccine1 received FDA approval in June 2006. This vaccine is intended to provide immunity against four common HPV types -- 16, 18, 6, & 11. It is marketed under the name Gardasil®.Scientific evidence on immunization with this quadrivalent vaccine suggests that it • substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 182,3,4 (responsible for ~70% of all cervical cancers in the US5 ) • substantially reduces the risk of genital warts caused by HPV types 6 & 116 (responsible for ~90% of all genital warts in the US7 ) • substantially reduces the risk of precancerous vulvar and vaginal lesions caused by HPV types 16 & 188 • is cost effective when administered to adolescent females9
However, there is no evidence to suggest that the vaccine • is effective against HPV types that are present at the time of immunization10 • reduces the risk of other sexually transmitted infections (STIs) • offers any protection against the other consequences of nonmarital sexual activity such as pregnancy and emotional damage
Furthermore, currently • one study suggests that immunization may provide limited protection against precancerous lesions caused by other types of HPV11 • the duration of immunity following immunization is unknown • the role of the vaccine for males is under investigation
Therefore, we • promote abstinence for unmarried persons as a primary method to prevent pregnancy,12,13 STIs including HIV,14 and the emotional consequences of sexual activity15 • promote monogamy as a primary method to prevent STIs including HIV16 • support the development and widespread use of vaccines against HPV and other STIs • encourage further research into the duration of immunity and the optimal timing of immunization • recommend continued regular health screening and counseling including pelvic examinations, Pap tests, and appropriate STI screening
Finally, we encourage physicians to counsel all their patients regarding sexual health. References: 1. FDA. FDA licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus. Available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html. Accessed July 17, 2006. 2. Koutsky LA, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002;347(21):1645-51. 3. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356:1915-27. 4. FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virilogic evidence of HPV infection. J Infect Dis. 2007;196:1438-46. 5. Munoz N, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348(6):518-27. 6. FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virilogic evidence of HPV infection. J Infect Dis. 2007;196:1438-46. 7. Villa LL, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like vaccine in young women: a randomized double-blind placebo-controlled mutlicentre phase II efficacy trial. Lancet Oncol. 2005;6(5):271-8. 8. FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virilogic evidence of HPV infection. J Infect Dis. 2007;196:1438-46. 9. Goldie SJ, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16.18 vaccine. J Nat Cancer Inst. 2004;96(8):604-614. 10. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356:1915-27. 11. Moscicki AB. HPV vaccines: today and in the future. J Adolesc Health. 2008;43:S26-S40. 12. Vincent ML, et al. Reducing adolescent pregnancy through school and community--based education. JAMA 1987;257:3382-86. 13. Doniger AS, et al. Impact evaluation of the "Not Me, Not Now" abstinence-oriented, adolescent pregnancy prevention communications program, Monroe County, New York. J Health Communications 2001. 14. Green EG. Rethinking AIDS Prevention: Learning from success in developing countries.Westport, CT: Praeger, 2003. 15. Hallfors DD, Waller MW, Bauer D, et al. Which comes first in adolescence--sex and drugs or depression? Am J Prev Med. 2005;29(3):163-70. 16. Michael, RT, et al. Sex in America: A Definitive Survey. 1st ed. viii, 300 p vols. Boston: Little, Brown, 1994, 1-300.
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