Vaccines, Blood & Biologics

Gardasil 9

STN:   125508
Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant
Tradename: Gardasil 9
Manufacturer: Merck & CO., Inc.

Indications: 

 Indicated in girls and women 9 through 26 years of age for the prevention of the following diseases:
  • Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. (1.1)
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.1)
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). (1.1)
  • Cervical intraepithelial neoplasia (CIN) grade 1. (1.1)
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. (1.1)
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. (1.1)
  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.1)
 Indicated in boys 9 through 15 years of age for the prevention of the following diseases:
  • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. (1.2)
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.2)
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. (1.2)

 Indicated in boys and men 9 through 26 years of age for the prevention of the following diseases:

  • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. (1.2)
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.2)

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. (1.2)

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 12/21/2015
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