THE 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®. A bivalent HPV vaccine, intended to provide immunity against HPV types 16 and 18, received FDA approval in October 2009.² It is marketed under the name Cervarix®.

Scientific evidence on immunization with the quadrivalent vaccine suggests that it

• substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 18^3,4,5 (responsible for ~70% of all cervical cancers in the US⁶)

• substantially reduces the risk of genital warts caused by HPV types 6 & 11⁷ (responsible for ~90% of all genital warts in the US⁸)

• substantially reduces the risk of precancerous vulvar and vaginal lesions caused by HPV types 16 & 18⁹

• is cost effective when administered to adolescent females¹⁰

Scientific evidence on immunization with the bivalent vaccine suggests that it

• substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 18¹¹ (responsible for ~70% of all cervical cancers in the US¹²)

However, there is no evidence to suggest that the vaccines

• are effective against HPV types that are present at the time of immunization^13,14

• reduce the risk of other sexually transmitted infections (STIs)

• offer any protection against the other consequences of nonmarital sexual activity such as pregnancy and emotional damage

Furthermore, currently

• a few studies suggest that immunization may provide limited protection against precancerous lesions caused by other types of HPV^15,16,17,18

• the duration of immunity following immunization is unknown^19,20

• the role of the vaccine for males is under investigation^21,22

Therefore, we

• promote abstinence for unmarried persons as a primary method to prevent pregnancy,^23,24 STIs including HIV,²⁵ and the emotional consequences of sexual activity²⁶

• promote monogamy as a primary method to prevent STIs including HIV²⁷

• 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 licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus [press release]. Silver Spring: U.S. Food and Drug Administration; June 8, 2006. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm. Accessed March 16, 2010.

2. FDA approves new vaccine for the prevention of cervical cancer [press release]. Silver Spring: U.S. Food and Drug Administration; Oct 16, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm187048.htm. Accessed March 16, 2010.

3. Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002;347:1645-1651.

4. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356:1915-1927.

5. 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;196:1438-1446.

6. Munoz N, Bosch FX, Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348:518-527.

7. 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;196:1438-1446.

8. Villa LL, Costa R, Petta CA, 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;6:271-278.

9. 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;196:1438-1446.

10. Goldie SJ, Kohli M, Grima D, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16.18 vaccine. J Nat Cancer Inst. 2004;96:604-614.

11. Paavonen J, Naud P, Salmeron J, et al. Efficacy of human papillomavirus (HPV)-16/18 ASO4-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009;374:301-314.

12. Munoz N, Bosch FX, Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348:518-527.

13. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356:1915-1927.

14. Paavonen J, Naud P, Salmeron J, et al. Efficacy of human papillomavirus (HPV)-16/18 ASO4-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009;374:301-314.

15. Moscicki AB. HPV vaccines: today and in the future. J Adolesc Health. 2008;43(Suppl 4):S26-S40.

16. Brown DR, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naïve women aged 16-26 years. J Infect Dis. 2009;199:926-935. Available from: http://www.journals.uchicago.edu/doi/pdf/10.1086/597307. Accessed March 23, 2010.

17. Wheeler CM, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009;199:936-944. Available from: http://www.journals.uchicago.edu/doi/pdf/10.1086/597309. Accessed March 26, 2010.

18. Paavonen J, Naud P, Salmeron J, et al. Efficacy of human papillomavirus (HPV)-16/18 ASO4-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009;374:301-314.

19. Olsson SE, Villa LL, Costa RLR, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine 2007;25:4931-4939.

20. Romanowski B, de Borba PC, Naud PS, et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV) - 16/18 ASO4-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 2009;374:1975-1985.

21. Kim JJ, Goldie SJ. Cost effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States. Br Med J. 2009;339:b3884. Available from: http://www.bmj.com/cgi/reprint/339/oct08_2/b3884. Accessed March 25, 2010.

22. FDA approves new indication for Gardasil to prevent genital warts in men and boys [press release]. Silver Spring: U.S. Food and Drug Administration; Oct. 16, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm187003.htm. Accessed March 16, 2010.

23. Vincent ML, Clearie AF, Schluchter MD. Reducing adolescent pregnancy through school and community--based education. JAMA. 1987;257:3382-3386.

24. Doniger AS, Adams E, Utter CA, Riley JS. Impact evaluation of the "Not Me, Not Now" abstinence-oriented, adolescent pregnancy prevention communications program, Monroe County, New York. J Health Commun. 2001;6:45-60.

25. Green EG. Rethinking AIDS Prevention: Learning from success in developing countries. Westport, CT: Praeger; 2003.

26. Hallfors DD, Waller MW, Bauer D, et al. Which comes first in adolescence--sex and drugs or depression? Am J Prev Med. 2005;29:163-170.

27. Michael RT, Gagnon JH, Laumann EO, Kolata G. Sex in America: A Definitive Survey. 1st ed. Canada: Little, Brown & Company; 1994.