Gardasil 9 Approved for Use in Women and Men 27 Through 45 Years Old

The FDA granted the Gardasil 9 application priority review status
The FDA granted the Gardasil 9 application priority review status

The Food and Drug Administration (FDA) has expanded the approval of Gardasil 9 (human papillomavirus 9-valent vaccine [HPV], recombinant; Merck) to include the use of the vaccine in women and men aged 27-45 years. Previously, the HPV vaccine was indicated for females and males 9-26 years of age.

The approval of the expanded age range was based on data from a clinical trial which evaluated the efficacy of Gardasil (quadrivalent human papillomavirus recombinant vaccine) in 3253 women 27-45 years of age with a median duration of follow-up of 3.5 years post-dose 3. Results showed that the efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, and 18-related persistent infection, genital warts, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, vulvar cancer, vaginal cancer, cervical dysplasia (any grade cervical intraepithelial neoplasia [CIN] ), anal intraepithelial neoplasia and cervical cancer in the per-protocol efficacy population was 87.7% (95% CI: 75.4%, 94.6%).

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In a long-term extension of this study, subjects (N=600) randomized to the Gardasil group in the base study were monitored for HPV 6-, 11-, 16-, and 18-related genital warts or cervical dysplasia; median duration of follow-up post-dose 3 was 8.9 years. No cases of HPV 6-, 11-, 16-, or 18- related CIN (any grade) or genital warts were observed in the per-protocol efficacy (PPE) population during the long-term extension phase.

For men, the effectiveness of Gardasil was inferred from efficacy data in women 27-45 years of age and supported by immunogenicity data from a study in which 150 men (27-45 years) received a 3-dose regimen of Gardasil over 6 months.

As the vaccines are manufactured similarly, the effectiveness of Gardasil in these patient populations is relevant to Gardasil 9, which covers the same 4 HPV types (6, 11, 16, 18) plus an additional 5 HPV types (31, 33, 45, 52, and 58). The quadrivalent vaccine is no longer being distributed in the US.

Gardasil 9 is supplied in 0.5mL single-dose vials and 0.5mL single-dose prefilled syringes.

For more information visit Merck.com.