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 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
GARDASIL 9 does not eliminate the necessity for girls to undergo recommended cervical cancer screening later in life.
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 US-GSL-01080. |
| 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. | Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68(32):698–702. |
| 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 April 4, 2017. |
| 25. | Centers for Disease Control and Prevention (CDC). Vaccination Coverage Among Adults in the United States, National Health Interview Survey, 2017. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2017.html. Reviewed February 8, 2018. Accessed September 18, 2019. |
| 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
WHAT THE CDC RECOMMENDS FOR HPV VACCINATION14
ROUTINE VACCINATION RECOMMENDED
for males and females at
age 11 or 12 years, but can be given
starting at age 9 years
CATCH-UP VACCINATION RECOMMENDED
for males and females
through age 26 years who are
not adequately vaccinated
SHARED CLINICAL DECISION-MAKING RECOMMENDED
for some males and females
ages 27 through 45 years who are
not adequately 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 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
GARDASIL 9 does not eliminate the necessity for girls to undergo recommended cervical cancer screening later in life.
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