Take a Stand Against Certain HPV-Related Cancers—Including Cervical and Oropharyngeal—With HPV Vaccination

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For Adolescents
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For Adults
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  1. Objio T, Morelli V, Trimble S. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 5: Storage and handling. Centers for Disease Control and Prevention. Updated August 2021. Accessed October 24, 2023. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html

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  1. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2024. Centers for Disease Control and Prevention. Last reviewed November 16, 2023. Accessed November 17, 2023. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
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  1. Recommended adult immunization schedule for ages 19 years or older, United States, 2024. Centers for Disease Control and Prevention. Last effective date February 28, 2024. Accessed March 19, 2024. https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
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  1. Vaccines to prevent human papillomavirus. Advisory Committee on Immunization Practices Vaccines for Children Program. Adopted and effective October 19, 2016. Accessed October 25, 2023. https://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/2016-10-2-hpv.pdf
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  1. AAP vaccine coding table 2023. American Academy of Pediatrics. Updated November 2023. Accessed January 11, 2024. https://downloads.aap.org/AAP/PDF/coding_vaccine_coding_table.pdf?_ga=2.257952778.1406650452.1677116595-1192231546.1677116594
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  1. ICD-10-CM tabular list of diseases and injuries. Centers for Medicare and Medicaid Services. Last updated June 29, 2023. Accessed December 4, 2023. https://www.cms.gov/files/zip/2024-code-tables-tabular-and-index-updated-06/29/2023.zip
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  1. 2024 ICD-10-CM – September 2023 update. Centers for Medicare and Medicaid Services. Last updated September 6, 2023. Accessed December 4, 2023. https://www.cms.gov/medicare/coding-billing/icd-10-codes/2024-icd-10-cm
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  1. Oh NL, Biddell CB, Rhodes BE, Brewer NT. Provider communication and HPV vaccine uptake: a meta-analysis and systematic review. Prev Med. 2021;148:106554. doi:10.1016/j.ypmed.2021.106554
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  1. Meites E, Gee J, Unger E, Markowitz L. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 11: Human Papillomavirus. Centers for Disease Control and Prevention. Updated August 2021. Accessed February 20, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hpv.pdf
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  1. HPV and oropharyngeal cancer. Centers for Disease Control and Prevention. Last reviewed November 14, 2023. Accessed May 16, 2024. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html
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  1. Human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed May 13, 2024. https://www.cdc.gov/std/treatment-guidelines/hpv.htm
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  1. Cancers caused by HPV. Centers for Disease Control and Prevention. Last reviewed February 28, 2022. Accessed June 6, 2024. https://www.cdc.gov/hpv/parents/cancer.html
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  1. Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human papillomavirus–attributable cancers — United States, 2012–2016. MMWR Morb Mortal Wkly Rep. 2019;68:724-728. doi:http://dx.doi.org/10.15585/mmwr.mm6833a3
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  1. HPV and cancer. National Cancer Institute. Updated October 18, 2023. Accessed October 19, 2023. https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer
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  1. 2023 population estimates by age and sex. Table 1. Population by age and sex: 2023. United States Census Bureau. May 2024. Accessed May 28, 2024. https://www.census.gov/data/tables/2023/demo/age-and-sex/2023-age-sex-composition.html
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  1. Saraiya M, Unger ER, Thompson TD, et al. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. J Natl Cancer Inst. 2015;107(6):1-12, s13-s26. doi:10.1093/jnci/djv086
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  1. 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-04591. Expires October 5, 2024
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  1. Lu P, Hung M, Srivastav A, et al. Surveillance of vaccination coverage among adult populations – United States, 2018. MMWR Surveill Summ. 2021;70(3):1-26. doi:10.15585/mmwr.ss7003a1
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  1. Kasting ML, Giuliano AR, Christy SM, Rouse CE, Robertson SE, Thompson EL. Human papillomavirus vaccination prevalence among adults aged 19–45 Years: An analysis of the 2017 National Health Interview Survey. Am J Prev Med. 2020;59(6):837–849. doi:10.1016/j.amepre.2020.05.031
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  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-GSL-04591. Expires October 5, 2024

Indication for GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal 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, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal 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.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

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].

GARDASIL ®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 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 a 2-dose schedule of GARDASIL 9 has not been established.

Dosage and Administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid or 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 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal 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, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal 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.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

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