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 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 26 years of age, GARDASIL 9 is administered using a
3-dose schedule at 0, 2 months, and6 months .
Before administering
| 1. | 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. |
| 2. | 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. |
| 3. | 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. |
| 4. | 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. |
| 5. | 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. |
| 6. | 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. |
| 7. | 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. |
| 8. | Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1096399-0000. |
| 9. | 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. |
| 10. | 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. |
| 11. | 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. |
| 12. | Schuchat A. Recommending HPV vaccine successfully. http://www.medscape.com/viewarticle/810030. Published September 3, 2013. Accessed May 1, 2017. |
| 13. | 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. |
| 14. | 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. |
| 15. | 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. |
| 16. | Finer LB, Philbin JM. Sexual initiation, contraceptive use, and pregnancy among young adolescents. Pediatrics. 2013;131(5):1–6. |
| 17. | Data available on request from Merck Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1208190-0000. |
| 18. | Centers for Disease Control and Prevention (CDC). Human papillomavirus. In: Hamborsky J, Kroger A, Wolf C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:175–186. |
| 19. | 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. |
Routine Recommendations
CDC's ACIP recommends routine HPV vaccination for both males and
11- or 12-year-old males should be vaccinated routinely13
11- or 12-year-old females should be vaccinated routinely13
- AAP, AAFP, and ACOG support the ACIP routine recommendation to vaccinate 11- and 12-year-old males and
females. 14
CDC's ACIP=Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
AAFP=American Academy of Family Physicians.
AAP=American Academy of Pediatrics.
ACOG=American College of Obstetricians and Gynecologists.
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 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 26 years of age, GARDASIL 9 is administered using a
3-dose schedule at 0, 2 months, and6 months .
Before administering