Indication for
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal cancer caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care professional.
Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care professional.
GARDASIL 9 has not been demonstrated to provide protection against diseases from vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).
Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
Select Safety Information for
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.
The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been established.
There was an increase in injection-site swelling reported at the injection site for GARDASIL 9 when administered concomitantly with Menactra and Adacel. The majority of injection-site swelling adverse experiences were reported as being mild to moderate in intensity.
Dosage and Administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
- For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a
2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least4 months after the second dose. For the3-dose schedule, GARDASIL 9 should be administered at 0,2 months , and6 months . - For individuals 15 through 45 years of age, GARDASIL 9 is administered using a
3-dose schedule at 0, 2 months, and6 months .
Before administering
| 1. | National Foundation for Infectious Diseases (NFID). Call to action: HPV vaccination as a public health priority. http://www.nfid.org/publications/cta/hpv-call-to-action.pdf. Published August 2014. Accessed March 25, 2017. |
| 2. | de Sanjose S, Quint WGV, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048–1056. |
| 3. | de Sanjose S, Alemany L, Ordi J, et al. Worldwide human papillomavirus genotype attribution in over 2000 cases of intraepithelial and invasive lesions of the vulva. Eur J Cancer. 2013;49(16):3450–3461. |
| 4. | Alemany L, Saunier M, Tinoco L, et al. Large contribution of human papillomavirus in vaginal neoplastic lesions: a worldwide study in 597 samples. Eur J Cancer. 2014;50(16):2846–2854. |
| 5. | Alemany L, Saunier M, Alvarado-Cabrero I, et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. Int J Cancer. 2015;136(1):98–107. |
| 6. | Joura EA, Ault KA, Bosch FX, et al. Attribution of 12 high-risk human papillomavirus genotypes to infection and cervical disease. Cancer Epidemiol Biomarkers Prev. 2014;23(10):1997–2008. |
| 7. | Garland SM, Steben M, Sings HL, et al. Natural history of genital warts: analysis of the placebo arm of 2 randomised phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009;199(6):805–814. |
| 8. | Guan P, Howell-Jones R, Li N, et al. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012;131(10):2349–2359. |
| 9. | Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1196399-0000. |
| 10. | Centers for Disease Control and Prevention (CDC). Storage and handling. In: Hamborsky J, Kroger A, Wolf C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:63–77. |
| 11. | Centers for Disease Control and Prevention (CDC). Vaccine administration. In: Hamborsky J, Kroger A, Wolf C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:79–106. |
| 12. | Centers for Disease Control and Prevention (CDC). National, regional, state, and selected local area vaccination coverage among adolescents aged 13–17 years—United States, 2014. https://www.cdc.gov/mmwr/ preview/mmwrhtml/mm6429a3.htm. Accessed June 22, 2017. |
| 13. | Schuchat A. Recommending HPV vaccine successfully. http://www.medscape.com/viewarticle/810030. Published September 3, 2013. Accessed May 1, 2017. |
| 14. | Petrosky E, Bocchini JA Jr, Hariri S, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015;64(11):300–304. |
| 15. | Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger—United States, 2017. https://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combined-schedule.pdf. Published January 1, 2017. Accessed May 8, 2017. |
| 16. | Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2014;63(RR-5):1–30. |
| 17. | Finer LB, Philbin JM. Sexual initiation, contraceptive use, and pregnancy among young adolescents. Pediatrics. 2013;131(5):1–6. |
| 18. | Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1244939-0000. |
| 19. | Centers for Disease Control and Prevention (CDC). Use of a 2-dose schedule for human papillomavirus vaccination—updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016;65(49):1405–1408. |
| 20. | Centers for Disease Control and Prevention (CDC). Human papillomavirus. In: Hamborsky J, Kroger A, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington DC: Public Health Foundation; 2015:175–186. |
| 21. | American Academy of Family Physicians (AAFP). Strong recommendation to vaccinate against HPV is key to boosting uptake. http://www.aafp.org/news/health-of-the-public/20140212hpv-vaccltr.html. Published February 12, 2014. Accessed May 7, 2017. |
| 22. | Markowitz LE, Dunne EF, Saraiya M, et al. Human Papillomavirus Vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2014;63(5):1–30. |
| 23. | Burger EA, Kim JJ, Sy S, Castle PE. Age of acquiring causal Human Papillomavirus (HPV) infections: leveraging simulation models to explore the natural history of HPV-induced cervical cancer. Clin Infect Dis. 2017;65(6):893–899. |
| 24. | Centers for Disease Control and Prevention (CDC). The Link Between HPV and Cancer. https://www.cdc.gov/hpv/parents/cancer.html. Updated December 16, 2016. Accessed February 14, 2018. |
| 25. | Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014;41(11):660–664. |
| 26. | Dempsey AF, Brewer SE, Pyrzanowski J, Sevick C, O’leary ST. Acceptability of human papillomavirus vaccines among women older than 26 years. Vaccine. 2015;33:1556–1561. |
| 27. | National Center for Health Statistics.1993. Section 1. In: Vital Statistics of the United States, 1989, Volume I – Natality. Public Health Service, Washington. U.S. Government Printing Office, |
| 28. | Barnard M, George P, Perryman ML, et al. Human papillomavirus (HPV) vaccine knowledge, attitudes, and uptake in college students: implications from the precaution adoption process model. PLOS ONE. 2017;12(8):1–9. |
| 29. | Rosenthal SL, Weiss TW, Zimet GD, et al. Predictors of HPV vaccine uptake among women aged 19–26: importance of a physician's recommendation. Vaccine. 2011;29(5):890–895. |
| 30. | Yanofsky VR, Patel RV, Goldenberg G. Genital warts: a comprehensive review. J Clin Aesthet Dermatol. 2012;5(6):25–36. |
| 31. | Centers for Disease Control and Prevention (CDC). The Link Between HPV and Cancer. https://www.cdc.gov/hpv/parents/cancer.html. Updated December 16, 2016. Accessed February 14, 2018. |
| 32. | American Cancer Society (ACS). Cancer Facts & Figures 2018. Atlanta, GA: American Cancer Society; 2018. |
| 33. | Chesson HW, Ekwueme DU, Saraiya M. Estimates of the annual direct medical costs of the prevention and treatment of disease associated with human papillomavirus in the United States. Vaccine. 2012;42(30):6016–6019. |
CDC Recommendations
CDC'S ACIP recommends HPV vaccination for both males and females14
Routine
CDC recommends routine HPV vaccination at age 11 or 12 years.
Vaccination can be given starting at 9 years.
Catch-up
- females 13–26
- males 13–21
For patients who have not been vaccinated previously,
CDC recommends vaccination for
Males aged 22–26 may also be vaccinated.
AAP, AAFP, and ACOG support the ACIP routine recommendation to vaccinate 11- and 12-year-old males and
CDC=Centers for Disease Control and Prevention.
AAFP=American Academy of Family Physicians.
AAP=American Academy of Pediatrics.
ACIP=Advisory Committee on Immunization Practices.
ACOG=American College of Obstetricians and Gynecologists.
Indication for
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal cancer caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care professional.
Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care professional.
GARDASIL 9 has not been demonstrated to provide protection against diseases from vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).
Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
Select Safety Information for
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.
The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been established.
There was an increase in injection-site swelling reported at the injection site for GARDASIL 9 when administered concomitantly with Menactra and Adacel. The majority of injection-site swelling adverse experiences were reported as being mild to moderate in intensity.
Dosage and Administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
- For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a
2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least4 months after the second dose. For the3-dose schedule, GARDASIL 9 should be administered at 0,2 months , and6 months . - For individuals 15 through 45 years of age, GARDASIL 9 is administered using a
3-dose schedule at 0, 2 months, and6 months .
Before administering