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Gardasil 9 FDA Approval History

Reviewed by Judith Stewart BPharm. Last updated on June 14, 2020.

FDA Approved: Yes (First approved December 10, 2014)
Brand name: Gardasil 9
Generic name: human papillomavirus 9-valent vaccine, recombinant
Dosage form: Injection
Company: Merck
Treatment for: Human Papillomavirus Prophylaxis

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine indicated for use in:

  • girls and women 9 through 45 years of age for the prevention of:
    • cervical, vulvar, vaginal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • boys and men 9 through 45 years for the prevention of:
    • anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Gardasil (human papillomavirus quadrivalent vaccine, recombinant) was first approved June 8, 2006. The last doses of Gardasil expired on May 1, 2017 and it is no longer available for use in the United States. Gardasil has now been replaced by Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant).

Development Timeline for Gardasil 9

DateArticle
Jun 15, 2020ApprovalFDA Approves Merck’s Gardasil 9 for the Prevention of Certain HPV-Related Head and Neck Cancers
Oct  5, 2018ApprovalFDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
Dec 15, 2015ApprovalFDA Approves Expanded Age Indication for Gardasil 9 in Males
Dec 10, 2014ApprovalFDA Approves Gardasil 9 for Prevention of Certain Cancers Caused by Five Additional Types of HPV

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.