Indication for GARDASIL 9

GARDASIL 9 is a vaccine indicated in females 9 through 26 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 26 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.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) does not eliminate the necessity for womengirls to continue 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 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

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 least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 26 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), please read the Prescribing Information. The Patient Information also is available.

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. Centers for Disease Control and Prevention (CDC). Surveillance of Vaccination Coverage Among Adult Populations—United States, 2015. https://www.cdc.gov/mmwr/volumes/66/ss/ss6611a1.htm. Updated June 21, 2017. Accessed January 21, 2018.
23. McQuillan G, Kruszon-Moran D. Prevalence of HPV in Adults Aged 18–69: United States, 2011–2014. NCHS Data Brief. 2017;280:1–7.
24. Rahman S, Pierce Campbell CM, Rolisson DE, et al. Seroprevalence and associated factors of 9-valent human papillomavirus (HPV) types among men in the multinational HIM study. PLOS ONE. 2016(11):1–16.
25. Bahmanyar ER, Paavonen J, et al. Prevalence and risk factors for cervical HPV infection and abnormalities in young adult women at enrolment in the multinational PATRICIA trial. Gynecologic Oncology. 2012;(127):440–450.
26. American Cancer Society (ACS). American Cancer Society Recommendations for Human Papillomavirus (HPV) Vaccine Use. https://www.cancer.org/cancer/cancer-causes/infectious-agents/hpv/acs-recommendations-for-hpv-vaccine-use.html. Revised July 19, 2016. Accessed February 14, 2018.
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, 1–370.
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.

Frequently Asked Questions

1.

Why 9 HPV types?

Worldwide estimated type contribution for certain HPV-related cancer and disease cases caused by 9 HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58):

  • Cervical cancer 90%2
  • Vulvar cancer 90%3,a
  • Vaginal cancer 85%4,a
  • Anal cancer 90%-95%5,a
  • High-grade cervical precancers 80%6,a,b
  • Low-grade cervical precancers 50%6,a
  • Genital warts 90%7,a

aNot all cervical precancers and lesions, and vulvar, vaginal, and anal cancer cases are caused by HPV. Approximately 90% of high-grade cervical precancers,8 75% of low-grade cervical lesions,8 30% of vulvar cancer cases,3 70% to 75% of vaginal cancer cases,4 and 85% to 90% of anal cancer cases5 are HPV related.

bHigh-grade cervical precancers defined as CIN 2/3.

CIN=cervical intraepithelial neoplasia.

Learn about the efficacy of GARDASIL 9 >

2.

What are the age indications for GARDASIL 9?

GARDASIL 9 is a vaccine indicated in females 9 through 26 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 26 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.

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Learn more about the routine recommendations for GARDASIL 9 >

3.

Is HPV vaccination recommended for males and females by any professional societies or organizations?

Yes, the CDC's Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination for 11- or 12-year-old males and females. Vaccination can be started at age 9. For those who have not been vaccinated previously. CDC's ACIP also recommends HPV vaccination for females 13 through age 26 and for males 13 through age 21. Males aged 22 through 26 can also be vaccinated14

See how you can improve your recommendation to parents of preteen patients>

Get tips on making a clear recommendation to your catch-up cohort patients>

4.

How is GARDASIL 9 packaged and stored?

GARDASIL9® (Human Papillomavirus 9-valent Vaccine, Recombinant) is supplied in 0.5-mL single-dose vials and prefilled syringes.

Storage for GARDASIL 9 :

  • Store refrigerated at 2°C to 8°C (36°F to 46°F).
  • Do not freeze; protect from light.
  • Vaccine should be administered as soon as possible after being removed from refrigeration.

Learn more about the storage and handling of GARDASIL 9 >

5.

What is the recommended dosage and administration of 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 least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 26 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Learn more about the dosage and administration of GARDASIL 9 >

6.

Can GARDASIL 9 be administered simultaneously with other vaccines?

Concomitant administration of GARDASIL 9, at a separate injection site, did not interfere with the antibody responses to any of these vaccines when compared with nonconcomitant administration of GARDASIL 9:

  • Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine]
  • Adacel® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

The rates of injection-site adverse reactions were similar between the concomitant group and nonconcomitant group (vaccination with GARDASIL 9 separated from vaccination with Menactra and Adacel by 1 month) with the exception of an increased rate of swelling reported at the injection site for GARDASIL 9 in the concomitant group (14.4%) compared to the nonconcomitant group (9.4%). The majority of injection-site swelling adverse reactions were reported as being mild to moderate in intensity.

Menactra and Adacel are the trademarks of their respective owners and are not trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Access concomitant use data for GARDASIL 9 >

7.

Is GARDASIL 9 funded through the Vaccines for Children (VFC) Program?

Funding will cover the cost of HPV vaccination with GARDASIL 9 for eligible males and females.c

cAdvisory Committee on Immunization Practices Vaccines for Children Program. Vaccines to prevent human papillomavirus. Resolution No. 10/16-2. Adopted and effective October 19, 2016. http://www.cdc.gov/vaccines/programs/vfc/
downloads/resolutions/2016-10-2-hpv.pdf. Accessed May 9, 2017.

Indication for GARDASIL 9

GARDASIL 9 is a vaccine indicated in females 9 through 26 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 26 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.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) does not eliminate the necessity for womengirls to continue 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 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

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 least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 26 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), please read the Prescribing Information. The Patient Information also is available.

VACC-1246170-0000 05/18