GARDASIL®9 FOR ADULTS

DISCUSS GARDASIL 9
WITH ADULT PATIENTS
THROUGH AGE 45.

You may be able to help protect them
from certain HPV-related cancers.

US HPV infections

Patient engagement
alt text

Millions of men and women aged 45 and under may still benefit from vaccination16

Help protect against certain HPV-related cancers caused by HPV types to which they haven’t yet been exposed.

HPV-related cancers
Recommend GARDASIL 9

GARDASIL 9 helps protect against certain cancers caused by 7 HPV typesa

  • Cervical
  • Vulvar
  • Oropharyngeal*

*Continued approval contingent upon confirmatory trial.

  • Vaginal
  • Anal

aHPV Types 16, 18, 31, 33, 45, 52, and 58.
HPV is not the only cause of these cancers.

HPV-related oropharyngeal cancers affect men ~5x more than women14,b

CDC-estimated 2012-2016 US incidence model of cancer cases attributed to 7 HPV types (16, 18, 31, 33, 45, 52, and 58)

For most people, HPV clears on its own. But for those who don’t clear the virus, it could cause certain cancers and diseases.10,11,12

~31,400 annual cancer cases in both men and women.14

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.

US Cancer Statistics assessed incidence of HPV-associated cancers to estimate the annual number of cancers caused by HPV, overall, and by state in 2012-2016.14

The estimated number of cancers attributable to HPV was calculated by multiplying the average number of HPV-associated cancers by the percentage of cancers diagnosed from 1993-2005 (prevaccine) that were attributable to HPV.14,17

Not all cervical, vulvar, vaginal, anal, and oropharyngeal cancers are caused by HPV.14

Detection of HPV DNA in an HPV study is insufficient to indicate a causal relation with the tumor.17

Go to Recommend GARDASIL 9
ref18

Reference

  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
ref1

Reference

  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

ref2

Reference

  1. Wolicki J, Miller E. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 6: Vaccine administration. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed October 25, 2023. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html
ref3

Reference

  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
ref11

Reference

  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
ref12

Reference

  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
ref16

Reference

  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
ref17

Reference

  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
ref14

Reference

  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
ref20

Reference

  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
ref19

Reference

  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
ref1-new

Reference

  1. Age and sex composition in the United States: 2019. Table 1. Population by age and sex: 2019. United States Census Bureau. April 2020. Accessed March 18, 2022.
    https://www.census.gov/data/tables/2019/demo/age-and-sex/2019-age-sex-composition.html
ref2-new

Reference

  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
ref3-new

Reference

  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
ref4-new

Reference

  1. FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. Food and Drug Administration. Published October 5, 2018. Accessed May 16, 2022.
    https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-gardasil-9-include-individuals-27-through-45-years-old
ref5-new

Reference

  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-03533.
ref6-new

Reference

  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 24, 2022.
    https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hpv.pdf
ref7-new

Reference

  1. Sexually transmitted infections treatment guidelines, 2021 – human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed January 7, 2022.
    https://www.cdc.gov/std/treatment-guidelines/hpv.htm
ref8-new

Reference

  1. HPV and oropharyngeal cancer. Centers for Disease Control and Prevention (CDC). Last reviewed December 13, 2021. Accessed July 25, 2022.
    https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm
ref9

Reference

  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
ref10

Reference

  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
study-design

Study Design of 2018 National Health Interview Study (NHIS)

Objective:
Assess vaccination coverage among adults aged ≥19 years for selected vaccines and demographic factors associated with vaccination.

Population/data source:
HPV vaccination data were from the NHIS, a cross-sectional survey conducted in-person through a household interview that is nationally representative of the US civilian, noninstitutionalized population.

The 2018 NHIS survey included 25,417 participants aged ≥19 years (response rate=53.1%).

The analyses included the sample of individuals aged 19-26 years (n=5930) from the total adult sample (persons aged ≥19 years) for all vaccine types (n=25,207).

Methodology:
As part of the survey, HPV vaccination status was determined on the basis of a person’s response to whether they had ever received the HPV shot. Adults aged 19-26 years who received ≥1 dose of HPV vaccination was assessed.

LIMITATIONS:
The data set did not include behavioral variables, including the use of preventive health services, vaccine safety concerns, state laws and immunization intervention programs, and cultural and religious factors.

NHIS data, such as vaccination status and demographic and other characteristics (eg, insurance status, usual source and frequency of health care), were self-reported and are subject to recall biases; vaccination status and demographic and other reported characteristics were not validated through medical records.

The response rate was 53.1%; nonresponse bias may have resulted if respondents and nonrespondents differed in their vaccination rates.

The NHIS sample excluded persons in the military and those residing in institutions, which might have resulted in underestimation or overestimation of overall US vaccination coverage levels.19

19Lu 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

study-design-nis

Study Design of 2022 National Immunization Survey (NIS)

Adolescents (N=16,043) in the NIS-Teen survey were born January 2004 through January 2010. The response rate was 23.0%, and 38.8% of adolescents with completed interviews had adequate provider data.

Of these adolescents, 3198 were aged 13 and 3019 were aged 17 at the time of interview. Vaccination coverage estimates are based on provider-reported vaccination histories and include any vaccines administered before the 2022 NIS-Teen interview date. Vaccination coverage by age 13 years was determined from adolescents born in 2008 and 2009 (those who reached age 13 years in 2021 and 2022, respectively).

“HPV vaccine” included 9-valent (9vHPV), quadrivalent (4vHPV), or bivalent (2vHPV) vaccines. HPV up-to-date included those with ≥3 doses and those with 2 doses when the first HPV vaccine dose was initiated prior to age 15 years and there was at least ≥5 months minus 4 days between the first and second dose. This update to the HPV vaccination recommendation occurred in December 2016.18

18Pingali C, Yankey D, Elam-Evans LD, et al. Vaccination coverage among adolescents aged 13–17 Years — National Immunization Survey–teen, United States, 2022. MMWR Morb Mortal Wkly Rep. 2023;72(34):912-919. doi:10.15585/mmwr.mm7234a3

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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