The HPV Vaccine: GARDASIL 9

 Gardasil 9, the HPV vaccine is the only vaccine that helps protect against certain cancers and diseases caused by 9 types of HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58). 

These 9 types are responsible for the majority of HPV-related cancers and diseases.

GARDASIL 9 works to help prevent disease when given before there is any contact with the virus.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccination for children at age 11 or 12, but it may be given as early as 9 years of age.

GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases

GARDASIL 9 helps protect against certain HPV-related cancers and precancers

  • Cervical cancer

  • Vulvar and vaginal cancers

  • Anal cancer

  • Genital warts (condyloma)

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS)

  • Cervical intraepithelial neoplasia (CIN) grade 1

  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

GARDASIL 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:

  • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.

  • And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Notes

The HPV vaccine does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The HPV vaccine is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or 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 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 does not protect against genital diseases not caused by HPV.

Vaccine Schedule

Ages 9 through 14 years

  • 2-dose 0, 6 to 12 months

Ages 15 through 45 years

  • 3-dose 0, 2, 6 months

Side Effects

Because individuals 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.

The most common (≥10%) local and systemic adverse reactions reported

In girls and women 16 through 26 years of age:

  • injection-site pain (89.9%)

  • injection-site swelling (40.0%)

  • injection-site erythema (34.0%)  

  • headache (14.6%)

In girls 9 through 15 years of age

  • injection-site pain (89.3%)

  • injection-site swelling (47.8%)

  • injection-site erythema (34.1%)

  • headache (11.4%)

In boys and men 16 through 26 years of age

  • injection-site pain (63.4%)

  • injection-site swelling (20.2%)

  • injection-site erythema (20.7%)

In boys 9 through 15 years of age

  • injection-site pain (71.5%)

  • injection-site swelling (26.9%)

  • injection-site erythema (24.9%)

 

 

 

 

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