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U.S. Department of Health and Human Services

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FDA Licenses Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) for the Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus

On June 8, 2006, the U.S. Food and Drug Administration approved Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil, Merck & Co., Inc.) for vaccination of females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:

  • Cervical cancer
  • Genital warts (condyloma acuminata)
  • The following precancerous or dysplastic lesions:
    • Cervical adenocarcinoma in situ (AIS)
    • Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
    • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
    • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
    • Cervical intraepithelial neoplasia (CIN) grade 1

This vaccine is not intended to be used for treatment of cervical cancer, CIN, VIN, VaIN, or genital warts.

Gardasil has not been shown to protect against diseases due to non-vaccine HPV types.

Vaccination does not substitute for routine cervical cancer screening. Gardasil recipients should continue to undergo cervical cancer screening per standard of care.

The efficacy of the vaccine was studied in four randomized, double-blind, placebo-controlled trials enrolling a total of 20,541 females between the ages of 16 and 26. Subjects were randomized to receive three doses of the vaccine (on a schedule of 0, 2, and 6 months) or placebo. The per-protocol population consisted of individuals who received all 3 vaccinations within 1 year of enrollment who did not have major deviations from the study protocol and were naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3. In the per-protocol population, the efficacy of the vaccine was:

  • 100% (95% CI: 92.9%, 100%) for prevention of HPV 16- or 18- related CIN 2/3 or AIS;
  • 95.2% (95% CI: 87.2%, 98.7%) for prevention of HPV 6-, 11-, 16-, or 18- related CIN or AIS;
  • 100% (95% CI: 55.5%, 100.0%) for prevention of HPV 16- or 18-related VIN 2/3 or VaIN 2/3; and
  • 98.9% (95% CI: 93.7%, 100.0%) for prevention of HPV 6-, 11-, 16-, or 18- related genital warts.

There was no clear evidence of protection from disease caused by HPV types for which subjects were PCR positive (cervicovaginal specimen) and/or seropositive at baseline. Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.

In the general study population, i.e., females with any HPV status at baseline who received at least one vaccine dose with case counting started at 1 month Postdose 1, the prophylactic efficacy of the vaccine was:

  • 39.0% (95% CI: 23.3%, 51.7%) for prevention of HPV 16- or 18- related CIN 2/3 or AIS;
  • 46.4% (95% CI: 35.2%, 55.7%) for prevention of HPV 6-, 11-, 16-, or 18- related CIN and AIS;
  • 9.1% (95% CI: 29.8%, 87.9%) for prevention of HPV 16- or 18-related VIN 2/3 and VaIN 2/3; and
  • 68.5% (95% CI: 57.5%, 77.0%) for prevention of HPV 6-, 11-, 16-, or 18- related genital warts.

Anti-HPV antibody responses 1 month Postdose 3 among 9-15 year old girls were non-inferior to anti-HPV responses in 16-26 year old females in the combined database of immunogenicity studies for Gardasil. On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9-15 years old girls was inferred. Administration of the vaccine with hepatitis B vaccine did not affect the immunogenicity of either vaccine, whether administered at the same or different visits.

The most common vaccination site toxicities observed for Gardasil compared to aluminum-containing placebo and saline placebo were pain (83.9% vs. 75.4% and 48.6%), swelling (25.4% vs. 15.8% and 7.3%), and erythema (24.6% vs. 18.4% and 12.1%). The most common systemic adverse events for Gardasil compared to saline placebo were fever (13.0% vs. 11.2%) and nausea (6.7% vs. 6.6%).

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at Gardasil  For additional Questions and Answers see: Gardasil 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500