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Millions of men and women aged 45 and under may still benefit from vaccination5,6

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

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 cancer has become the most common HPV-related cancer7

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

For most people, HPV clears on its own. But for those who don’t clear the virus, it could cause certain cancers and diseases.6, 8, 9

~31,400 HPV-attributable cancer cases per year7

Annual Statistics of Certain HPV-related Cancer Cases in Men and Women

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 2012-2016.7

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.7,10

Not all cervical, vulvar, vaginal, anal, and oropharyngeal cancers are caused by HPV.7

Detection of HPV DNA in an HPV study is insufficient to indicate a causal relation with the tumor.10

Don’t assume adults through age 45 have been vaccinated

According to National Health Interview Survey (NHIS) data based on a 2019 analysis11,b

bNote that 718 respondents did not answer the question linked to the outcome of interest (“Have you ever received an HPV shot or vaccine?”) and were therefore excluded from the logistic regression analysis. We built crude and adjusted models, and using multivariable logistic regression, we estimated associations between sociodemographic factors and HPV vaccine uptake, obtaining odds ratios at a 95% confidence interval to determine statistical significance.11

Study design

There is still an opportunity to vaccinate appropriate adults aged 18-26

According to NHIS data based on a 2018, 2019, and 2022 analysis12,b

Study design

Seize the opportunity to help protect your appropriate adult patients against certain HPV-related cancers.

References:

  1. 2023 population estimates by age and sex. Table 1. Population by age and sex: 2023. United States Census Bureau. May 2024. Accessed May 20, 2025.
    https://www.census.gov/data/tables/2023/demo/age-and-sex/2023-age-sex-composition.html
  2. Meites E, Gee J, Unger E, Markowitz L. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Chapter 11: Human Papillomavirus. Centers for Disease Control and Prevention. April 23, 2024. Accessed July 9, 2025. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-11-human-papillomavirus.html
  3. 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
  4. HPV and oropharyngeal cancer. Centers for Disease Control and Prevention. September 17, 2024. Accessed September 25, 2024.
    https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html
  5. Human papillomavirus (HPV) infection. Centers for Disease Control and Prevention. Last reviewed July 22, 2021. Accessed April 28, 2025. https://www.cdc.gov/std/treatment-guidelines/hpv.htm
  6. 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
  7. Rincon NL, McDowell KR, Weatherspoon D, et al. Racial and ethnic disparities in human papillomavirus (HPV) vaccine uptake among United States adults, aged 27-45 years. Hum Vaccin Immunother. 2024;20(1):2313249. doi:10.1080/21645515.2024.2313249
  8. Sonawane K, Garg A, Meissner EG, et al. Human papillomavirus vaccination among young adults before and during the COVID-19 pandemic. JAMA Netw Open. 2024;7(2):e2356875. doi:10.1001/jamanetworkopen.2023.56875

studyDesignHPV

Study design

Objective

  • Assess the self-reported HPV vaccination status in adults aged 27-45 years in 2019.11

Population/data source

  • HPV vaccination data were from the NHIS, a cross-sectional survey conducted face-to-face through a household interview that is nationally representative of the US civilian, noninstitutionalized population.11,13
  • A total of 9440 adults aged 27 to 45 years with HPV vaccination information were identified in 2019 (50.9% females, 49.1% males), and 68.9% were married/partnered.11

Methodology

  • As a 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 or vaccine (data collection 2018-2019). Adults aged 27 to 45 years who received ≥1 dose HPV vaccine were assessed.11

Limitations

  • NHIS data were self-reported and are subject to reporting biases.11
  • While individuals in the study were between 27 and 45 years, they may have received their HPV vaccine at an earlier age and the exact year of receiving the HPV vaccine was not established in this study.11
  • In 2019, the total household response rate was 61.1%.13
  • The NHIS sample excluded persons in the military, those with no fixed household address, and those residing in institutions.13

References:

  1. Rincon NL, McDowell KR, Weatherspoon D, et al. Racial and ethnic disparities in human papillomavirus (HPV) vaccine uptake among United States adults, aged 27-45 years. Hum Vaccin Immunother. 2024;20(1):2313249. doi:10.1080/21645515.2024.2313249
  1. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. National health interview survey: 2019 survey description. Centers for Disease Control and Prevention. September 2020. Accessed April 14, 2025. https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHIS/2019/srvydesc-508.pdf
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studyDesignHPV2

Study design

Objective

  • Assess the self-reported HPV vaccination rate by sociodemographic characteristics in adults aged 18 to 26 years in 2018, 2019, and 2022.12

Population/data source

  • HPV vaccination data were from the NHIS, a cross-sectional survey typically conducted in person through a household interview that is nationally representative of the US civilian, noninstitutionalized population.12,14
  • A total of 2159 adults aged 18 to 26 years with HPV vaccination information were identified in 2022 (50.5% females, 49.5% males).12

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 18-26 who received ≥1 dose of HPV vaccination were assessed.12

Limitations

  • NHIS data were self-reported and are subject to recall biases.12
  • The response rate was 47.7%.14
  • The NHIS sample excluded persons in the military, those with no fixed household address, and those residing in institutions.14
  • Lack of data on transgender and nonbinary individuals, HIV or immunocompromised status, and total number of doses received, prohibiting presentation of up-to-date status.12

References:

  1. Sonawane K, Garg A, Meissner EG, et al. Human papillomavirus vaccination among young adults before and during the COVID-19 pandemic. JAMA Netw Open. 2024;7(2):e2356875. doi:10.1001/jamanetworkopen.2023.56875
  1. National Health Interview Survey 2022 survey description. Centers for Disease Control and Prevention. U.S. Department of Health and Human Services. June 2023. Accessed February 12, 2025. https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHIS/2022/srvydesc-508.pdf
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Indication

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

Select Safety Information

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

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 accompanying Prescribing Information. The Patient Information also is available.

Indication

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 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 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine for patients 9 through 45 years of age for the prevention of certain cancers and other diseases caused by 9 types of human papillomavirus (HPV).

 

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.

 

Click to view full Indication.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine for patients 9 through 45 years of age for the prevention of certain cancers and other diseases caused by 9 types of human papillomavirus (HPV).

 

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.

 

Click to view full Indication.

Select Safety Information

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

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 accompanying Prescribing Information. The Patient Information also is available.

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 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].